(12) Patent Application Publication (10) Pub. No.: US 2015/0018432 A1 Prakash Et Al

US 201500 18432A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2015/0018432 A1 Prakash et al. (43) Pub. Date: Jan. 15, 2015

(54) COMPOSITIONS AND METHODS USING (52) U.S. Cl. REBAUDIOSIDE XTO PROVIDE CPC ...... A2.3L I/2363 (2013.01); A61K 47/36 SWEETNESSENHANCEMENT (2013.01) (71) Applicants: Indra Prakash, Alpharetta, GA (US); USPC 514/777; 426/658; 426/548; 426/650: 426/3; Juvenal Higiro, Atlanta, GA (US); 426/618; 426/580: 426/590: 426/72: 426/61; Mary Campbell, Acworth, GA (US) 426/71; 426/656: 426/532: 426/66: 426/593; 426/594:426/597: 426/599 (72) Inventors: Indra Prakash, Alpharetta, GA (US); s s Juvenal Higiro, Atlanta, GA (US); Mary Campbell, Acworth, GA (US) (57) ABSTRACT (21) Appl. No.: 14/036,654 Sweetened compositions comprising at least one Sweetener (22) Filed: Sep. 25, 2013 and rebaudioside X are provided herein. Rebaudioside X is present in the Sweetened compositions in a concentrationator Related U.S. Application Data below the sweetness recognition threshold, while the at least (60) Provisional application No. 61/845,812, filed on Jul. one Sweetener is present in a concentration above its Sweet 12, 2013. sy- . 1–s ness recognition threshold. Rebaudioside X acts to enhance the Sweetness of the Sweetened compositions, e.g. beverages Publication Classification and concentrate compositions, thereby allowing for prepara (51) Int. Cl tion of Sweetened compositions with reduced calorie content. A2.3L I/236 (2006.01) Methods of enhancing the Sweetness of a Sweetened compo A6 IK 47/36 (2006.01) sition with rebaudioside Xare also provided herein. Patent Application Publication Jan. 15, 2015 Sheet 1 of 4 US 201S/0018432 A1

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COMPOSITIONS AND METHODS USING taste, bitterness, astringency, Sweet aftertaste, bitter after REBAUDIOSIDE XTO PROVIDE taste, licorice aftertaste, and become more prominent with SWEETNESSENHANCEMENT increase of concentration. These undesirable taste attributes are particularly prominent in carbonated beverages, where CROSS REFERENCE TO RELATED full replacement of Sugar requires concentrations of Steviol APPLICATIONS glycosides that exceed 500 mg/L. Use of steviol glycosides at Such concentrations results in significant deterioration in the 0001. This application claims priority under 35 U.S.C. final product taste. S119 to U.S. Provisional Patent Application No. 61/845,812, 0007 Accordingly, there remains a need to address the filed Jul. 12, 2013. The contents of the above-referenced taste issues of natural Sweeteners and reduce caloric content priority document is hereby fully incorporated herein by ref of compositions containing traditional Sweeteners. CCC. SUMMARY OF THE INVENTION 0008. In one embodiment, the present invention provides a FIELD OF THE INVENTION Sweetened composition comprising at least one Sweetener 0002 The present invention relates generally to the use of and rebaudioside X, wherein the at least one Sweetener is rebaudioside X as a Sweetness enhancer. The present inven present in a concentration above its Sweetness recognition threshold, wherein rebaudioside X is present in a concentra tion provides Sweetened compositions (e.g., beverages) and tion at or below its Sweetness recognition threshold, and concentrate compositions comprising at least one Sweetener wherein rebaudioside Xenhances the sweetness of the Sweet and rebaudioside X. The present invention also relates to ened composition by an amount more than the detectable methods for enhancing the Sweetness of a Sweetened compo Sweetness of a solution containing the same concentration of sition using rebaudioside X. rebaudioside X in the absence of the at least one Sweetener and/or the rebaudioside X enhances the sweetness of the BACKGROUND OF THE INVENTION sweetened composition by about 1.0% (w/v) sucrose equiva lence or greater, such as, for example, about 1.5% (w/v) or 0003 Natural caloric sugars, such as sucrose, fructose and greater. In another embodiment, the rebaudiosideX enhances glucose, are utilized to provide a pleasant taste to beverages, the sweetness of the Sweetened composition from about 1.0% to about 3.0% (w/v) sucrose equivalence. foods, pharmaceuticals, oral hygienic and cosmetic products. 0009. The present invention also provides a method for Sucrose, in particular, imparts a taste preferred by consumers. enhancing the Sweetness of a Sweetened composition com Although Sucrose provides Superior Sweetness characteris prising at least one Sweetener in a concentration above its tics, it is caloric. Non-caloric or low caloric sweeteners have Sweetness recognition threshold, said method comprising been introduced to satisfy consumer demand. However, adding rebaudioside X to the Sweetened composition in a Sweeteners within this class differ from natural caloric Sugars concentrationator below its Sweetness recognition threshold, in ways that consumers do not perceive the same taste quality. wherein the rebaudioside X enhances the Sweetness of the Onataste basis, non-caloric or low caloric Sweeteners exhibit Sweetened composition by an amount more than the detect a temporal profile, maximal response, flavor profile, mouth able Sweetness of a solution containing the same concentra feel, and/or adaptation behavior that differ from sugar. Spe tion of rebaudioside X and/or the rebaudioside X enhances cifically, non-caloric or low caloric Sweeteners exhibit the sweetness of the sweetened composition by about 1.0% delayed Sweetness onset, lingering Sweet aftertaste, bitter (w/v) Sucrose equivalence or greater. taste, metallic taste, astringent taste, cooling taste and/or lico 0010. In preferred embodiments, the rebaudiosideX has a rice-like taste. On a source basis, many non-caloric or low purity from about 80% to about 99%, i.e. rebaudioside X caloric Sweeteners are synthetic chemicals. The desire for a accounts for about 80% to about 99% by weight of the Stevia natural non-caloric or low caloric Sweetener that tastes like extract or mixture of Steviol glycosides. In a preferred Sucrose remains high. embodiment, the rebaudioside X has a purity greater than 0004 Stevia rebaudiana Bertoni is a perennial shrub of the about 95%. Asteraceae (Compositae) family native to certain regions of 0011. The Sweetener can be any natural or synthetic sweetener. In a preferred embodiment, the sweetener is a South America. Its leaves have been traditionally used for caloric Sweetener. In another embodiment, the Sweetener is a hundreds of years in Paraguay and Brazil to Sweeten local teas carbohydrate Sweeteners such as, for example. Sucrose, fruc and medicines. The plant is commercially cultivated in Japan, tose, glucose, high fructose corn syrup, high fructose starch Singapore, Taiwan, Malaysia, South Korea, China, Israel, syrup and/or combinations thereof. In still another embodi India, Brazil, Australia and Paraguay. ment, the Sweetener is a rare Sugar, such as, for example, 0005. The leaves of the plant contain a mixture containing D-psicose, D-allose, D-turanose, D-tagatose, D-trehalose, diterpene glycosides in an amount ranging from about 10 to D-leucrose, rare Sugar syrup and/or combinations thereof. 20% of the total dry weight. These diterpene glycosides are 0012. The Sweetened composition is selected from the about 150 to 450 times sweeter than sugar. Structurally, the group consisting of pharmaceutical compositions, edible gel diterpene glycosides are characterized by a single base, Ste mixes and compositions, dental compositions, foodstuffs, viol, and differ by the presence of carbohydrate residues at confections, condiments, chewing gum, cereal compositions, positions C13 and C19. Typically, on a dry weight basis, the baked goods, dairy products, tabletop Sweetener composi four major steviol glycosides found in the leaves of Stevia are tions, beverages and beverage products. Dulcoside A (0.3%), Rebaudioside C (0.6-1.0%), Rebaudio 0013 The Sweetened compositions of the present inven side A (3.8%) and Stevioside (9.1%). Other glycosides iden tion may further comprise any number of functional ingredi tified in Stevia extract include Rebaudioside B, D, E, and F. ents and/or additives. Steviolbioside and Rubusoside. Among these, only Stevio 0014. In a preferred embodiment, the sweetened compo side and Rebaudioside A are available on a commercial scale. sition is a beverage. The beverages comprise a liquid matrix. 0006. The use of steviol glycosides has been limited to In some embodiments, the beverage is a reduced-calorie bev date by certain undesirable taste properties, including licorice erage. US 2015/0018432 A1 Jan. 15, 2015

0015. In another embodiment, the present invention also 0022 Rebaudioside X is present in minute quantities in provides a concentrate composition comprising at least one Stevia rebaudiana, about 0.05-0.5% by weight. Methods of sweetener and rebaudioside X, wherein theat least one Sweet isolating rebaudioside X have been disclosed in the co-pend ener is present in the beverage in a concentration above its ing application PCT/US2012/070562, the contents of which sweetness recognition threshold and the rebaudioside X is are incorporated herein by reference. presentina concentrationator below it Sweetness recognition 0023 RebaudiosideX (also referred to as rebaudioside M) threshold once the concentrate composition is either (i) added is also commercially available from Chromadex. to the full-strength beverage or (ii) diluted to a full-strength 0024. The present invention is based on the discovery that beverage, and wherein the concentrate composition enhances rebaudioside X acts as a Sweetness enhancer when used in the Sweetness of a beverage by an amount more than the certain concentrations in compositions, e.g. beverages, con detectable Sweetness of a solution containing the same con taining traditional caloric Sweeteners. Therefore, the present centration of rebaudioside X in the concentrate composition invention allows for the reduction of the amount of caloric and/or the concentrate composition enhances the Sweetness Sweetener(s) used in said compositions. of the beverage containing at least one Sweetener by about 1.0% (w/v) Sucrose equivalence or greater. I. DEFINITIONS 0016 Suitable concentrate compositions include, for example, syrups, powdered beverages, flavor packets or fla 0025. The term “sweetness recognition threshold, as gen erally used herein, is the lowest known concentration of a Vor enhancer drops. Sweet compound that is perceivable by the human sense of BRIEF DESCRIPTION OF THE FIGURES taste. As such, rebaudioside X enhances or potentiates the Sweet taste of Sweeteners without providing any noticeable 0017 FIG. 1: illustrates the CNMR spectrum of RebX sweet taste by itself when present below its sweetness recog (150 MHz, CDN). nition threshold concentration. However, rebaudioside X 0018 FIG. 2: illustrates the "H NMR spectrum of Reb X may provide a detectable Sweet taste at concentrations above (600 MHz, CDN). its Sweetness recognition threshold. The Sweetness recogni 0019 FIG.3: illustrates the H-H COSY spectrum of Reb tion threshold of rebaudioside X is about 20 to about 30 ppm. X (600 MHz, CDN). 0026. The term “isosweet,” as used herein, refers to com 0020 FIG. 4: illustrates the HMBC spectrum of Reb X positions that have equivalent Sweetness. Generally, the (600 MHz, CDN). Sweetness of a given composition is typically measured with reference to a solution of sucrose. See “A Systematic Study of DETAILED DESCRIPTION OF THE INVENTION Concentration-Response Relationships of Sweeteners. G. E. 0021 Recently, rebaudioside X, 13-(2-O-B-D-glucopy DuBois, D. E. Walters, S. S. Schiffman, Z. S. Warwick, B.J. ranosyl-3-O-B-D-glucopyranosyl-B-D-glucopyranosyl)oxy Booth, S. D. Pecore, K. Gibes, B.T. Carr, and L. M. Brands, ent kaur-16-en-19-oic acid-(2-O-B-D-glucopyranosyl-3-O- in Sweeteners: Discovery, Molecular Design and Chemore B-D-glucopyranosyl-B-D-glucopyranosyl)ester. WaS ception, D. E. Walters, F. T. Orthoefer, and G. E. DuBois, isolated from Stevia rebaudiana and characterized: Eds. American Chemical Society, Washington, D.C. (1991), pp. 261-276. 0027. The term “sucrose equivalence,” as used herein, refers to the Sweetness of a composition containing at least one non-Sucrose Sweetener against a Sucrose reference. Typi cally, taste panelists are trained to detect Sweetness of refer ence Sucrose solutions containing between 1-15% Sucrose (w/v). Other non-Sucrose Sweeteners are then tasted at a series of dilutions to determine the concentration of the non-Su crose, i.e. rebaudioside X, Sweetener that is as Sweet (i.e. isoSweet) to a given percent Sucrose reference. 0028. For example, if a 1% solution of a sweetener com position containing a carbohydrate Sweetener and rebaudio side X is as Sweet as a 10% sucrose solution, then the sweet ener composition is said to be 10 times as potent as Sucrose, and has 10%. Sucrose equivalence. II. COMPOSITIONS

HO 0029 A. Sweetened Compositions 0030. In one embodiment, the present invention provides a HO Sweetened composition comprising at least one Sweetener HO and rebaudioside X. The at least one sweetener, which is not rebaudiosideX, is present in a concentration above the Sweet ness recognition threshold. In contrast, rebaudioside X is present in the Sweetened composition in a concentration at or below its sweetness recognition threshold. The Sweetness recognition threshold of rebaudioside X is about 20-30 ppm, which is sufficient to provide about a Sucrose equivalence of about 1.0-1.5%. US 2015/0018432 A1 Jan. 15, 2015

0031 Rebaudioside X, when present in the sweetened Sweeteners include Sucrose, fructose, glucose, erythritol, composition in a concentration at or below the Sweetness maltitol, lactitol, Sorbitol, mannitol. Xylitol, tagatose, treha recognition threshold, enhances the Sweetness of a Sweetened lose, leucrose, galactose, rhamnose, cyclodextrin (e.g., C.-cy composition by an amount more than the detectable Sweet clodextrin, B-cyclodextrin, and Y-cyclodextrin), ribulose, ness of a solution containing the same concentration of rebau threose, arabinose, Xylose, lyxose, allose, altrose, mannose, dioside X (in the absence of any additional sweeteners). In idose, lactose, maltose, invert Sugar, isotrehalose, neotreha other words, the increase in isoSweetness of a Sweetened lose, palatinose or isomalitulose, erythrose, deoxyribose, composition containing rebaudioside X in an amount at or gulose, idose, talose, erythrulose, Xylulose, psicose, turanose, below its Sweetness recognition threshold concentration cellobiose, glucosamine, mannosamine, fucose, fuculose, compared to the same Sweetened composition in the absence glucuronic acid, gluconic acid, glucono-lactone, abequose, of rebaudioside X is greater than the isosweetness of a solu galactosamine, Xylo-oligosaccharides (Xylotriose, Xylobiose tion of rebaudioside X (in the absence of any additional and the like), gentio-oligoscaccharides (gentiobiose, gentiot Sweeteners). riose, gentiotetraose and the like), galacto-oligosaccharides, 0032. As an example, a solution containing 20 ppm rebau Sorbose, ketotriose (dehydroxyacetone), aldotriose (glyceral dioside X was found to be isosweet to a 1.0% (w/v) sucrose dehyde), nigero-oligosaccharides, fructooligosaccharides solution. A beverage containing 7.0% (w/v) sucrose and 20 (kestose, nystose and the like), maltotetraose, maltotriol, tet ppm rebaudioside X was isosweet to a 9.5% (w/v) sucrose rasaccharides, mannan-oligosaccharides, malto-oligosac Solution. Accordingly, the increase in isoSweetness provided charides (maltotriose, maltotetraose, maltopentaose, malto by the 20 ppm rebaudioside X (2.5% (w/v)) is greater than the hexaose, maltoheptaose and the like), dextrins, lactulose, sweetness of 20 ppm rebaudioside X alone (1.0% (w/v)). melibiose, raffinose, rhamnose, ribose, isomerized liquid Therefore, it can be said that the effect of rebaudioside X is sugars such as high fructose corn/starch syrup (HFCS/HFSS) not merely additive to the sucrose in the beverage (if that were (e.g., HFCS55, HFCS42, or HFCS90), coupling sugars, soy the case, one would expect an isosweetness of 8.0% (w/v)), bean oligosaccharides, glucose syrup and combinations but rather is acting to enhance the detected sweetness of the thereof. Sucrose in beverage. 0039. In a particular embodiment, the Sweetener is a car 0033. In one embodiment, rebaudioside X enhances the bohydrate Sweetener selected from the group consisting of sweetness of the Sweetened composition by about 1.0% (w/v) glucose, fructose, Sucrose, high fructose corn Syrup and com Sucrose equivalence or greater. The rebaudiosideX enhances binations thereof. the sweetness of the sweetened composition from about 1.0% 0040. In another particular embodiment, the carbohydrate to about 3.0% (w/v) sucrose equivalence, such as, for Sweeteneris a rare Sugar selected from the group consisting of example, about 1.1%, about 1.2%, about 1.3%, about 1.4%, D-psicose, D-allose, D-turanose, D-tagatose, D-trehalose, about 1.5%, about 1.6%, about 1.7%, about 1.8%, about D-leucrose and combinations thereof. 1.9%, about 2.0%, about 2.1%, about 2.2%, about 2.3%, 0041. In yet other embodiments, the sweetener is a syn about 2.4%, about 2.5%, about 2.6%, about 2.7%, about thetic sweetener. As used herein, the phrase “synthetic sweet 2.8%, about 2.9% or about 3.0% sucrose equivalence. ener” refers to any composition which is not found naturally 0034. In another particular embodiment, rebaudioside X in nature and characteristically has a Sweetness potency enhances the Sweetness of the Sweetened composition by greater than Sucrose, fructose, or glucose, yet has less calo about 1.5% (w/v) sucrose equivalence or greater. The rebau ries. Non-limiting examples of synthetic high-potency Sweet dioside X enhances the Sweetness of the Sweetened compo eners suitable for embodiments of this disclosure include sition from about 1.5% to about 3.0% (w/v) sucrose equiva Sucralose, potassium acesulfame, acesulfame acid and salts lence, such as, for example, about 1.5%, about 1.6%, about thereof, aspartame, alitame, saccharin and salts thereof, neo 1.7%, about 1.8%, about 1.9%, about 2.0%, about 2.1%, hesperidin dihydrochalcone, cyclamate, cyclamic acid and about 2.2%, about 2.3%, about 2.4%, about 2.5%, about salts thereof, neotame, advantame, glucosylated Steviol gly 2.6%, about 2.7%, about 2.8%, about 2.9% or about 3.0% cosides (GSGs) and combinations thereof. Sucrose equivalence. 0042. In still other embodiments, the sweetener can be a 0035. The rebaudioside X can be provided as a purified natural high potency Sweetener that is not rebaudioside X. material (e.g. 100% pure) or as part of a Stevia extract or Suitable natural high potency Sweeteners include, but are not mixture of Steviol glycosides. In one embodiment, rebaudio limited to, rebaudioside A, rebaudioside B, rebaudioside C, side X is from about 80% to about 99% pure, that is, rebau rebaudioside D, rebaudioside E, rebaudioside F, rebaudioside dioside X comprises about 80% to about 99% by weight in a I, rebaudioside H, rebaudioside L, rebaudioside K, rebaudio Stevia extract or Steviol glycoside mixture. In a particular side J, rebaudioside N, rebaudioside O. dulcoside A, dulco embodiment, rebaudioside X is about 95% pure. side B, rubusoside, Stevia, Stevioside, mogroside IV. mogro 0036 Moreover, the form of rebaudioside X can be poly side V. Luo Han Guo Sweetener, siamenoside, monatin and its morphic, amorphous or a combination thereof. In one salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid embodiment, the rebaudioside X is Form. A rebaudioside X. and its salts, thaumatin, monellin, mabinlin, braZZein, her In another embodiment, the rebaudioside X is amorphous nandulcin, phyllodulcin, glycyphyllin, phloridzin, trilobtain, rebaudioside X. Furthermore the rebaudioside X can be baiyunoside, osladin, polypodoside A, pterocaryoside A, spray-dried. pterocaryoside B, mukurozioside, phlomisoside I, periandrin 0037. The Sweetener in the Sweetened composition may I, abrusoside A, Steviolbioside and cyclocarioside I. The natu be any caloric or non-caloric, natural or synthetic Sweetener. ral high potency Sweetener can be provided as a pure com In a preferred embodiment, the Sweetener is a caloric Sweet pound or, alternatively, as part of an extract. C. 0043. The sweetened compositions can have any concen 0038. In one embodiment, the Sweetener is a carbohydrate tration of Sweetener described herein. In some embodiments, sweetener. Non-limiting examples of suitable carbohydrate the Sweetened composition has a Sweetener concentration of US 2015/0018432 A1 Jan. 15, 2015

at least about 2% (w/v), such as, for example, from about 2% threshold, wherein the rebaudioside X is present in a concen to about 15%, or from about 5% to about 12%. tration at or below the Sweetness recognition threshold, and 0044. In one embodiment, a Sweetened composition com wherein the rebaudioside X enhances the Sweetness of said prises rebaudioside X having greater than about 95% purity Sweetened composition by an amount more than the detect and at least one Sweetener selected from the group consisting able Sweetness of a solution containing the same concentra of Sucrose, fructose, glucose, high fructose corn syrup, high tion of rebaudioside X (in the absence of any other sweet fructose starch syrup, D-psicose, D-allose, D-turanose, ener). D-tagatose, D-trehalose, D-leucrose, rare Sugar syrup and/or 0050. In another particular embodiment, a sweetened a combination thereof, wherein the at least one Sweetener is composition comprises rebaudioside X having a purity present in a concentration above the Sweetness recognition greater than about 95% and D-allose, wherein D-allose is threshold concentration, wherein the rebaudioside X is present in a concentration above the Sweetness recognition present in a concentration at or below the Sweetness recogni threshold, wherein the rebaudioside X is present in a concen tion threshold, and wherein the rebaudiosideX enhances the tration at or below the Sweetness recognition threshold, and Sweetness of said Sweetened composition by an amount more wherein the rebaudioside X enhances the Sweetness of said than the detectable Sweetness of a solution containing the Sweetened composition by an amount more than the detect same concentration of rebaudioside X (in the absence of any able Sweetness of a solution containing the same concentra additional Sweeteners). tion of rebaudioside X (in the absence of any other sweet 0045. In a particular embodiment, a sweetened composi ener). tion comprises rebaudioside X having a purity greater than 0051. In another particular embodiment, a sweetened about 95% and Sucrose, wherein Sucrose is present in a con composition comprises rebaudioside X having a purity centration above the Sweetness recognition threshold, greater than about 95% and D-turanose, wherein D-turanose wherein the rebaudioside X is present in a concentration at or is present in a concentration above the Sweetness recognition below the sweetness recognition threshold, and wherein the threshold, wherein the rebaudioside X is present in a concen rebaudioside X enhances the sweetness of said sweetened tration at or below the Sweetness recognition threshold, and composition by an amount more than the detectable Sweet wherein the rebaudioside X enhances the Sweetness of said ness of a solution containing the same concentration of rebau Sweetened composition by an amount more than the detect dioside X (in the absence of any other sweetener). able Sweetness of a solution containing the same concentra 0046. In another particular embodiment, a sweetened tion of rebaudioside X (in the absence of any other sweet composition comprises rebaudioside X having a purity ener). greater than about 95% and fructose, wherein fructose is 0052. In another particular embodiment, a sweetened present in a concentration above the Sweetness recognition composition comprises rebaudioside X having a purity threshold, wherein the rebaudioside X is present in a concen greater than about 95% and D-tagatose, wherein D-tagatose is tration at or below the Sweetness recognition threshold, and present in a concentration above the Sweetness recognition wherein the rebaudioside X enhances the Sweetness of said threshold, wherein the rebaudioside X is present in a concen Sweetened composition by an amount more than the detect tration at or below the Sweetness recognition threshold, and able Sweetness of a solution containing the same concentra wherein the rebaudioside X enhances the Sweetness of said tion of rebaudioside X (in the absence of any other sweet Sweetened composition by an amount more than the detect ener). able Sweetness of a solution containing the same concentra 0047. In another particular embodiment, a sweetened tion of rebaudioside X (in the absence of any other sweet composition comprises rebaudioside X having a purity ener). greater than about 95% and glucose, wherein glucose is 0053. In another particular embodiment, a sweetened present in a concentration above the Sweetness recognition composition comprises rebaudioside X having a purity threshold, wherein the rebaudioside X is present in a concen greater than about 95% and D-trehalose, wherein D-trehalose tration at or below the Sweetness recognition threshold, and is present in a concentration above the Sweetness recognition wherein the rebaudioside X enhances the Sweetness of said threshold, wherein the rebaudioside X is present in a concen Sweetened composition by an amount more than the detect tration at or below the Sweetness recognition threshold, and able Sweetness of a solution containing the same concentra wherein the rebaudioside X enhances the Sweetness of said tion of rebaudioside X (in the absence of any other sweet Sweetened composition by an amount more than the detect ener). able Sweetness of a solution containing the same concentra 0048. In another particular embodiment, a sweetened tion of rebaudioside X (in the absence of any other sweet composition comprises rebaudioside X having a purity ener). greater than about 95% and high fructose corn syrup, wherein 0054. In another particular embodiment, a sweetened high fructose corn syrup is present in a concentration above composition comprises rebaudioside X having a purity the sweetness recognition threshold, wherein the rebaudio greater than about 95% and D-leucrose, wherein D-leucrose side X is present in a concentration at or below the Sweetness is present in a concentration above the Sweetness recognition recognition threshold, and wherein the rebaudioside X threshold, wherein the rebaudioside X is present in a concen enhances the Sweetness of said Sweetened composition by an tration at or below the Sweetness recognition threshold, and amount more than the detectable Sweetness of a solution wherein the rebaudioside X enhances the Sweetness of said containing the same concentration of rebaudioside X (in the Sweetened composition by an amount more than the detect absence of any other Sweetener). able Sweetness of a solution containing the same concentra 0049. In another particular embodiment, a sweetened tion of rebaudioside X (in the absence of any other sweet composition comprises rebaudioside X having a purity ener). greater than about 95% and D-psicose, wherein D-psicose is 0055. In another particular embodiment, a sweetened present in a concentration above the Sweetness recognition composition comprises rebaudioside X having a purity US 2015/0018432 A1 Jan. 15, 2015

greater than about 95% and rare Sugar syrup, wherein rare the sweetness recognition threshold, and wherein the rebau Sugar syrup is present in a concentration above the Sweetness dioside X enhances the Sweetness of the Sweetened compo recognition threshold, wherein the rebaudioside X is present sition by at least about 1.0% (w/v) sucrose equivalence. In a in a concentration at or below the Sweetness recognition more particular embodiment, the rebaudioside X enhances threshold, and wherein the rebaudioside X enhances the the sweetness of the Sweetened composition from about 1.0% Sweetness of said Sweetened composition by an amount more to about 3.0% (w/v) sucrose equivalence. than the detectable Sweetness of a solution containing the 0061. In another particular embodiment, a sweetened same concentration of rebaudioside X (in the absence of any composition comprises rebaudioside X having a purity other sweetener). greater than about 95% and D-psicose, wherein D-psicose is 0056. In one embodiment, a Sweetened composition com present in a concentration above the Sweetness recognition prises rebaudioside Xhaving a purity greater than about 95% threshold concentration, wherein the rebaudioside X is and at least one Sweetener selected from the group consisting present in a concentration at or below the Sweetness recogni of Sucrose, fructose, glucose, high fructose corn syrup, high tion threshold, and wherein the rebaudioside X enhances the fructose starch syrup, D-psicose, D-allose, D-turanose, Sweetness of the Sweetened composition by at least about D-tagatose, D-trehalose, D-leucrose, rare Sugar syrup or a 1.0% (w/v) sucrose equivalence. In a more particular embodi combination thereof, wherein the at least one Sweetener is ment, the rebaudioside X enhances the sweetness of the present in a concentration above the Sweetness recognition sweetened composition from about 1.0% to about 3.0% (w/v) threshold concentration, wherein the rebaudioside X is Sucrose equivalence. present in a concentration at or below the Sweetness recogni 0062. In another particular embodiment, a sweetened tion threshold, and wherein the rebaudiosideX enhances the composition comprises rebaudioside X having a purity Sweetness of the Sweetened composition by at least about greater than about 95% and D-allose, wherein D-allose is 1.0% (w/v) sucrose equivalence. present in a concentration above the Sweetness recognition 0057. In a more particular embodiment, a sweetened com threshold concentration, wherein the rebaudioside X is position comprises rebaudioside X having a purity greater present in a concentration at or below the Sweetness recogni than about 95% and sucrose, wherein sucrose is present in a tion threshold, and wherein the rebaudioside X enhances the concentration above the Sweetness recognition threshold con Sweetness of the Sweetened composition by at least about centration, wherein the rebaudioside X is present in a con 1.0% (w/v) sucrose equivalence. In a more particular embodi centration at or below the Sweetness recognition threshold, ment, the rebaudioside X enhances the sweetness of the and wherein the rebaudioside X enhances the sweetness of sweetened composition from about 1.0%to about 3.0% (w/v) the Sweetened composition by at least about 1.0% (w/v) Sucrose equivalence. Sucrose equivalence. In a more particular embodiment, the rebaudioside X enhances the Sweetness of the sweetened 0063. In another particular embodiment, a sweetened composition from about 1.0% (w/v) to about 3.0% (w/v) composition comprises rebaudioside X having a purity Sucrose equivalence. greater than about 95% and D-turanose, wherein D-turanose 0058. In another particular embodiment, a sweetened is present in a concentration above the Sweetness recognition composition comprises rebaudioside X having a purity threshold concentration, wherein the rebaudioside X is greater than about 95% and fructose, wherein fructose is present in a concentration at or below the Sweetness recogni present in a concentration above the Sweetness recognition tion threshold, and wherein the rebaudioside X enhances the threshold concentration, wherein the rebaudioside X is Sweetness of the Sweetened composition by at least about present in a concentration at or below the Sweetness recogni 1.0% (w/v) sucrose equivalence. In a more particular embodi tion threshold, and wherein the rebaudiosideX enhances the ment, the rebaudioside X enhances the sweetness of the Sweetness of the Sweetened composition by at least about sweetened composition from about 1.0% to about 3.0% (w/v) 1.0% (w/v) sucrose equivalence. In a more particular embodi Sucrose equivalence. ment, the rebaudioside X enhances the Sweetness of the 0064. In another particular embodiment, a sweetened sweetened composition from about 1.0% to about 3.0% (w/v) composition comprises rebaudioside X having a purity Sucrose equivalence. greater than about 95% and D-tagatose, wherein D-tagatose is 0059. In another particular embodiment, a sweetened present in a concentration above the Sweetness recognition composition comprises rebaudioside X having a purity threshold concentration, wherein the rebaudioside X is greater than about 95% and glucose, wherein glucose is present in a concentration at or below the Sweetness recogni present in a concentration above the Sweetness recognition tion threshold, and wherein the rebaudioside X enhances the threshold concentration, wherein the rebaudioside X is Sweetness of the Sweetened composition by at least about present in a concentration at or below the Sweetness recogni 1.0% (w/v) sucrose equivalence. In a more particular embodi tion threshold, and wherein the rebaudiosideX enhances the ment, the rebaudioside X enhances the sweetness of the Sweetness of the Sweetened composition by at least about sweetened composition from about 1.0% to about 3.0% (w/v) 1.0% (w/v) sucrose equivalence. In a more particular embodi Sucrose equivalence. ment, the rebaudioside X enhances the Sweetness of the 0065. In another particular embodiment, a sweetened sweetened composition from about 1.0% to about 3.0% (w/v) composition comprises rebaudioside X having a purity Sucrose equivalence. greater than about 95% and D-trehalose, wherein D-trehalose 0060. In another particular embodiment, a sweetened is present in a concentration above the Sweetness recognition composition comprises rebaudioside X having a purity threshold concentration, wherein the rebaudioside X is greater than about 95% and high fructose corn syrup, wherein present in a concentration at or below the Sweetness recogni high fructose corn syrup is present in a concentration above tion threshold, and wherein the rebaudioside X enhances the the Sweetness recognition threshold concentration, wherein Sweetness of the Sweetened composition by at least about the rebaudioside X is present in a concentration at or below 1.0% (w/v) sucrose equivalence. In a more particular embodi US 2015/0018432 A1 Jan. 15, 2015

ment, the rebaudioside X enhances the Sweetness of the 0074 Non-carbonated beverages include, but are not lim sweetened composition from about 1.0% to about 3.0% (w/v) ited to fruit juice, fruit-flavored juice, juice drinks, nectars, Sucrose equivalence. Vegetable juice, vegetable-flavored juice, sports drinks, 0066. In another particular embodiment, a sweetened energy drinks, protein drinks, enhanced water with Vitamins, composition comprises rebaudioside X having a purity near water drinks (e.g., water with natural or synthetic fla greater than about 95% and D-leucrose, wherein D-leucrose Vorants), coconut water, tea type (e.g. black tea, green tea, red is present in a concentration above the Sweetness recognition tea, oolong tea), coffee, cocoa drink, beverage containing threshold concentration, wherein the rebaudioside X is milk components (e.g. milk beverages, coffee containing present in a concentration at or below the Sweetness recogni milk components, café au lait, milk tea, fruit milk beverages). tion threshold, and wherein the rebaudiosideX enhances the beverages containing cereal extracts, Smoothies and combi Sweetness of the Sweetened composition by at least about nations thereof. 1.0% (w/v) sucrose equivalence. In a more particular embodi 0075 Beverages contain a liquid matrix, i.e. the basic ment, the rebaudioside X enhances the Sweetness of the ingredient in which the ingredients—including the Sweetener sweetened composition from about 1.0% to about 3.0% (w/v) and rebaudioside X of the present invention—are dissolved. Sucrose equivalence. In one embodiment, the liquid matrix is water of beverage 0067. In another particular embodiment, a sweetened quality, such as, for example deionized water, distilled water, composition comprises rebaudioside X having a purity reverse osmosis water, carbon-treated water, purified water, greater than about 95% and rare Sugar syrup, wherein rare demineralized water and combinations thereof, can be used. Sugar syrup is present in a concentration above the Sweetness Additional suitable liquid matrices include, but are not lim recognition threshold concentration, wherein the rebaudio ited to phosphoric acid, phosphate buffer, citric acid, citrate side X is present in a concentration at or below the Sweetness buffer and carbon-treated water. recognition threshold, and wherein the rebaudioside X 0076. In one embodiment, the beverage contains inclu enhances the Sweetness of the Sweetened composition by at sions, i.e. pulp, seed, chunks, etc. Carbohydrate Sweeteners least about 1.0% (w/v) Sucrose equivalence. In a more par can be present in the beverage in a concentration from about ticular embodiment, the rebaudiosideX enhances the Sweet 100 ppm to about 140,000 ppm. Rare sugars can be present in ness of the Sweetened composition from about 1.0% to about the beverage in a concentration from about 50 ppm to about 3.0% (w/v) sucrose equivalence. 100,000 ppm. Synthetic sweeteners may be present in the 0068. The Sweetened composition can be any edible or beverage in a concentration from about 0.3 ppm to about oral composition suitable for use in the mouth or ingestion. 3,500 ppm. Natural high potency sweeteners may be preset in Exemplary Sweetened compositions include, for example, the beverage in a concentration from about 0.1 ppm to about pharmaceutical compositions, edible gel mixes and compo 3,000 ppm. sitions, dental compositions, foodstuffs (confections, condi 0077. The beverage can further include additives includ ments, chewing gum, cereal compositions, baked goods, ing, but not limited to, carbohydrates, polyols, amino acids dairy products, and tabletop Sweetener compositions), bever and their corresponding salts, poly-amino acids and their ages and beverage products. corresponding salts, Sugar acids and their corresponding 0069. The Sweetened composition can further contain one salts, nucleotides, organic acids, inorganic acids, organic salts or more functional ingredients, detailed below. Functional including organic acid salts and organic base salts, inorganic ingredients include, but are not limited to, vitamins, minerals, salts, bitter compounds, caffeine, flavorants and flavoring antioxidants, preservatives, glucosamine, polyphenols and ingredients, astringent compounds, proteins or protein combinations thereof. Any Suitable functional ingredient hydrolysates, Surfactants, emulsifiers, weighing agents, juice, described herein can be used. dairy, cereal and other plant extracts, flavonoids, alcohols, 0070 The Sweetened composition can further contain one polymers and combinations thereof. Any suitable additive or more additives including, but not limited to, carbohydrates, described herein can be used. polyols, amino acids and their corresponding salts, poly 0078. In one embodiment, the polyol can be present in the amino acids and their corresponding salts, Sugar acids and beverage in a concentration from about 100 ppm to about their corresponding salts, nucleotides, organic acids, inor 250,000 ppm, such as, for example, from about 5,000 ppm to ganic acids, organic salts including organic acid salts and about 40,000 ppm. organic base salts, inorganic salts, bitter compounds, caf 0079. In another embodiment, the amino acid can be feine, flavorants and flavoring ingredients, astringent com present in the beverage in a concentration from about 10 ppm pounds, proteins or protein hydrolysates, Surfactants, emul to about 50,000 ppm, such as, for example, from about 1,000 sifiers, weighing agents, juice, dairy, cereal and other plant ppm to about 10,000 ppm, from about 2,500 ppm to about extracts, flavonoids, alcohols, polymers and combinations 5,000 ppm or from about 250 ppm to about 7,500 ppm. thereof. Any suitable additive described herein can be used. 0080. In still another embodiment, the nucleotide can be (0071 1. Beverages present in the beverage in a concentration from about 5 ppm 0072. In a particular embodiment, the Sweetened compo to about 1,000 ppm. sition is a beverage. I0081. In yet another embodiment, the organic acid addi 0073. As used herein, a “beverage' is a ready-to-drink tive can be present in the beverage in a concentration from beverage. Suitable ready-to-drink beverages include carbon about 10 ppm to about 5,000 ppm. ated and non-carbonated beverages. Carbonated beverages I0082 In yet another embodiment, the inorganic acid addi include, but are not limited to, Soft drinks, cola, lemon-lime tive can be present in the beverage in a concentration from flavored sparkling beverage, orange flavored sparkling bev about 25 ppm to about 25,000 ppm. erage, grape flavored sparkling beverage, Strawberry flavored I0083. In still another embodiment, the bitter compound sparkling beverage, pineapple flavored sparkling beverage, can be present in the beverage in a concentration from about ginger-ale, Soft drinks, root beer and malt beverages. 25 ppm to about 25,000 ppm. US 2015/0018432 A1 Jan. 15, 2015

0084. In yet another embodiment, the flavorant can be additives, such as, for example, erythritol. The beverage can present in the beverage a concentration from about 0.1 ppm to further include functional ingredients, such as vitamins. about 5,000 ppm. 0102. In one embodiment, a beverage comprises at least 0085. In a still further embodiment, the polymer can be one Sweetener and rebaudioside X having a purity greater present in the beverage in a concentration from about 30 ppm than about 95%, wherein the at least one sweetener selected to about 2,000 ppm. from the group consisting of Sucrose, fructose, glucose, high I0086. In another embodiment, the protein hydrosylate can fructose corn Syrup, high fructose starch syrup, D-psicose, be present in the beverage in a concentration from about 200 D-allose, D-turanose, D-tagatose, D-trehalose, D-leucrose, ppm to about 50,000. rare Sugar syrup or a combination thereof is present in a 0087. In yet another embodiment, the surfactant additive concentration above its Sweetness recognition threshold, can be present in the beverage in a concentration from about wherein rebaudioside X is present in a concentration at or 30 ppm to about 2,000 ppm. below its sweetness recognition threshold, and wherein 0088. In still another embodiment, the flavonoid additive rebaudiosideX enhances the Sweetness of the beverage by an can be present in the beverage a concentration from about 0.1 amount more than the detectable Sweetness of a solution ppm to about 1,000 ppm. containing the same concentration of rebaudioside X in the 0089. In yet another embodiment, the alcohol additive can absence of the at least one Sweetener. be present in the beverage in a concentration from about 625 0103) In another embodiment, a beverage comprises ppm to about 10,000 ppm. rebaudiosideX having a purity greater than about 95% and at 0090. In a still further embodiment, the astringent additive least one Sweetener selected from the group consisting of can be present in the beverage in a concentration from about Sucrose, fructose, glucose, high fructose corn Syrup, high 10 ppm to about 5,000 ppm. fructose starch syrup, D-psicose, D-allose, D-turanose, 0091. The beverage can further contain one or more func D-tagatose, D-trehalose, D-leucrose, rare Sugar syrup or a tional ingredients, detailed below. Functional ingredients combination thereof, wherein the at least one sweetener is include, but are not limited to, Vitamins, minerals, antioxi present in a concentration above the Sweetness recognition dants, preservatives, glucosamine, polyphenols and combi threshold concentration, wherein the rebaudioside X is nations thereof. Any suitable functional ingredient described present in a concentration at or below the Sweetness recogni herein can be used. tion threshold, and wherein the rebaudioside X enhances the 0092. It is contemplated that the pH of the beverage does sweetness of the beverage by at least about 1.0% (w/v) not materially or adversely affect the Sweetness enhance Sucrose equivalence, such as, for example, from about 1.0% ment. A non-limiting example of the pH range of the beverage to about 3.0%. may be from about 1.8 to about 10. A further example 0104. In one embodiment, a reduced-calorie soda com includes a pH range from about 2 to about 5. In a particular prises, for example, caramel color, phosphoric acid, Sugar embodiment, the pH of beverage can be from about 2.5 to (i.e. sucrose, HFCS or HFSS), rebaudioside X, potassium about 4.2. One of skill in the art will understand that the pH of benzoate, natural colors, citric acid, and caffeine. the beverage can vary based on the type of beverage. Dairy 0105. In another embodiment, a reduced-calorie soda beverages, for example, can have pHs greater than 4.2. comprises, for example, caramel color, phosphoric acid, 0093. The titratable acidity of the beverage may, for Sugar, erythritol, rebaudiosideX, potassium benzoate, natural example, range from about 0.01 to about 1.0% by weight of colors, citric acid, and caffeine. beverage. 0106. In still another embodiment, a reduced-calorie soda 0094. In one embodiment, the sparkling beverage product comprises, for example, caramel color, phosphoric acid, has an acidity from about 0.01 to about 1.0% by weight of the Sugar, erythritol, D-tagatose, rebaudioside X, potassium ben beverage, such as, for example, from about 0.05% to about Zoate, natural colors, citric acid, and caffeine. 0.25% by weight of beverage. 0107. In yet another embodiment, a reduced-calorie soda 0095. The carbonation of a sparkling beverage product has comprises, for example, caramel color, phosphoric acid, 0 to about 2% (w/w) of carbon dioxide or its equivalent, for Sugar, D-tagatose, rebaudiosideX, potassium benzoate, natu example, from about 0.1 to about 1.0% (w/w). ral colors, citric acid, and caffeine. 0096. The temperature of the beverage may, for example, 0108. In one embodiment, a reduced-calorie soda com range from about 4°C. to about 100°C., such as, for example, prises, for example, caramel color, phosphoric acid, Sugar, from about 4° C. to about 25° C. D-psicose, rebaudioside X, potassium benzoate, natural col 0097. The beverage can be a full-calorie beverage that has ors, citric acid, and caffeine. up to about 120 calories per 8 oz. serving. 0109. In another embodiment, a reduced-calorie lemon 0098. The beverage can be a mid-calorie beverage that has lime carbonated soft drink comprises, for example, Sugar, up to about 60 calories per 8 oz serving. rebaudioside X, natural flavors, citric acid, Sodium citrate, 0099. The beverage can be a low-calorie beverage that has Sodium benzoate, malic acid and Stevia leaf extract. up to about 40 calories per 8 oz. serving. 0110. In still another embodiment, a half-calorie lemon 0100. The beverage can be a zero-calorie that has less than lime carbonated soft drink comprises, for example, Sugar, about 5 calories per 8 oz. serving. erythritol, rebaudioside X, natural flavors, citric acid, malic 0101. In one embodiment, a beverage comprises a carbo acid, Sodium citrate, sodium benzoate and Stevia leaf extract. hydrate sweetener and between about 20-30 ppm rebaudio 0111. In one embodiment, a reduced-calorie orange-fla side X, wherein the liquid matrix of the beverage is selected Vored carbonated soft drink comprises, for example, Sugar, from the group consisting of water, phosphoric acid, phos rebaudioside X, natural flavors, citric acid, modified food phate buffer, citric acid, citrate buffer, carbon-treated water starch, Sodium hexametaphosphate, glycerol ester of rosin, and combinations thereof. The pH of the beverage can be yellow 6, sodium benzoate, stevia leaf extract, brominated from about 2.5 to about 4.2. The beverage can further include vegetable oil and red 40. US 2015/0018432 A1 Jan. 15, 2015

0112. In another embodiment, a reduced-calorie citrus tem, for contraception, for obstetrics and gynecology, for the flavored carbonated Soft drink comprises, for example, Sugar, skin, for infections and infestations, for immunology, for rebaudioside X, natural flavors, citric acid, potassium citrate, allergic disorders, for nutrition, for neoplastic disorders, for concentrated grape fruit juice, potassium Sorbate, potassium diagnostics, for euthanasia, or other biological functions or benzoate, EDTA, acacia, glycerol ester of rosin, brominated disorders. Examples of suitable pharmaceutically active sub Vegetable oil and carobbean gum. stances for embodiments of the present invention include, but 0113. In another embodiment, a reduced-calorie sports are not limited to, antacids, reflux Suppressants, antiflatulents, drink comprises, for example, rebaudioside X, citric acid, antidopaminergics, proton pump inhibitors, cytoprotectants, salt, monopotassium phosphate, magnesium chloride, cal prostaglandin analogues, laxatives, antispasmodics, antidiar cium chloride, natural flavors, sugar, vitamins B3, B6, B12, rhoeals, bile acid sequestrants, opioids, beta-receptor block blue 1, ascorbic acid, and calcium disodium EDTA. ers, calcium channel blockers, diuretics, cardiac glycosides, 0114. In still another embodiment, a reduced-calorie spicy cherry carbonated Soft drink comprises, for example, rebau antiarrhythmics, nitrates, antianginals, vasoconstrictors, dioside X, Sugar caramel color, phosphoric acid, potassium vasodilators, peripheral activators, ACE inhibitors, angio Sorbate, potassium benzoate, artificial and natural flavors, tensin receptor blockers, alpha blockers, anticoagulants, hep caffeine, monosodium phosphate, lactic acid, and polyethyl arin, antiplatelet drugs, fibrinolytics, anti-hemophilic factors, ene glycol. haemostatic drugs, hypolipidaemic agents, statins, hynoptics, 0115. In yet another embodiment, an enhanced water bev anaesthetics, antipsychotics, antidepressants, anti-emetics, erage comprises, for example, rebaudioside X, erythritol, anticonvulsants, antiepileptics, anxiolytics, barbiturates, Sugar, magnesium and calcium lactate, potassium phosphate, movement disorder drugs, stimulants, benzodiazepines, citric acid, natural flavors, vitamin C (ascorbic acid), phos cyclopyrrolones, dopamine antagonists, antihistamines, cho phoric acid, calcium phosphate, vitamins B3, E, B5, B6, B12, linergics, anticholinergics, emetics, cannabinoids, analge Zinc gluconate and vitamin A palmitate sics, muscle relaxants, antibiotics, aminoglycosides, anti-vi 0116. Use of rebaudiosideX in a concentrationator below rals, anti-fungals, anti-inflammatories, anti-gluacoma drugs, its Sweetness recognition threshold in a beverage containing a sympathomimetics, steroids, ceruminolytics, bronchodila Sweetener in a concentration above its Sweetness recognition tors, NSAIDS, antitussive, mucolytics, decongestants, corti threshold means less caloric Sweetener is required to provide costeroids, androgens, antiandrogens, gonadotropins, growth the same Sucrose equivalence. Accordingly, the amount of hormones, insulin, antidiabetics, thyroid hormones, calcito caloric sweetener in a beverage can be reduced by about 15% nin, diphosphonates, vasopressin analogues, alkalizing to about 20%, while providing the same Sucrose equivalence. agents, quinolones, anticholinesterase, sildenafil, oral contra 0117 Use of rebaudiosideX in a concentrationator below ceptives, Hormone Replacement Therapies, bone regulators, its Sweetness recognition threshold in a beverage containing a follicle stimulating hormones, luteinizings hormones, gamo Sweetener in a concentration above its Sweetness recognition lenic acid, progestogen, dopamine agonist, Oestrogen, pros threshold can provide a reduced calorie beverage with a taglandin, gonadorelin, clomiphene, tamoxifen, diethylstil sucrose equivalence from about 7.5% to about 10.0% (w/v), bestrol, antileprotics, antituberculous drugs, antimalarials, where the amount of Sucrose in the beverage is less than anthelmintics, antiprotozoal, antiserums, vaccines, interfer would normally be used to provide a 7.5%-10.0% (w/v) ons, tonics, vitamins, cytotoxic drugs, sex hormones, aro Sucrose solution (in the absence of any additional Sweeten matase inhibitors, Somatostatin inhibitors, or similar type ers). Substances, or combinations thereof. Such components gen 0118 2. Other Sweetened Compositions erally are recognized as safe (GRAS) and/or are U.S. Food 0119 Pharmaceutical Compositions and Drug Administration (FDA)-approved. 0120 In one embodiment, the Sweetened composition is a I0123. The pharmaceutically active substance is present in pharmaceutical composition. The pharmaceutical composi the pharmaceutical composition in widely ranging amounts tion may be in the form of a syrup, an emulsion, a Suspension, depending on the particular pharmaceutically active agent a solution, or any other liquid form for providing the pharma being used and its intended applications. An effective dose of ceutical composition to a patient. In particular embodiments, any of the herein described pharmaceutically active sub the pharmaceutical composition may be in a form for oral stances can be readily determined by the use of conventional administration, buccal administration, Sublingual administra techniques and by observing results obtained under analo tion, or any other route of administration as known in the art. gous circumstances. In determining the effective dose, a num 0121. As referred to herein, “pharmaceutically active sub ber of factors are considered including, but not limited to: the stance' means any drug, drug formulation, medication, pro species of the patient; its size, age, and general health; the phylactic agent, therapeutic agent, or other substance having specific disease involved; the degree of involvement or the biological activity. As referred to herein, “excipient material severity of the disease; the response of the individual patient; refers to any inactive Substance used as a vehicle for an active the particular pharmaceutically active agent administered; ingredient. Such as any material to facilitate handling, stabil the mode of administration; the bioavailability characteristic ity, dispersibility, wettability, and/or release kinetics of a of the preparation administered; the dose regimen selected; pharmaceutically active Substance. and the use of concomitant medication. The pharmaceutically 0122) Suitable pharmaceutically active substances active Substance is included in the pharmaceutically accept include, but are not limited to, medications for the gas able carrier, diluent, or excipient in an amount Sufficient to trointestinal tract or digestive system, for the cardiovascular deliver to a patient a therapeutic amount of the pharmaceuti system, for the central nervous system, for pain or conscious cally active Substance in vivo in the absence of serious toxic ness, for musculo-skeletal disorders, for the eye, for the ear, effects when used in generally acceptable amounts. Thus, nose and oropharynx, for the respiratory system, for endo suitable amounts can be readily discerned by those skilled in crine problems, for the reproductive system or urinary sys the art. US 2015/0018432 A1 Jan. 15, 2015

0.124. According to particular embodiments of the present dings, jellies, pastes, trifles, aspics, marshmallows, gummy invention, the concentration of pharmaceutically active Sub candies, or the like. Edible gel mixes generally are powdered stance in the pharmaceutical composition will depend on or granular solids to which a fluid may be added to form an absorption, inactivation, and excretion rates of the drug as edible gel composition. Non-limiting examples of fluids for well as other factors known to those of skill in the art. It is to use in particular embodiments include water, dairy fluids, be noted that dosage values will also vary with the severity of dairy analogue fluids, juices, alcohol, alcoholic beverages, the condition to be alleviated. It is to be further understood and combinations thereof. Non-limiting examples of dairy that for any particular Subject, specific dosage regimes should fluids which may be used in particular embodiments include be adjusted overtime according to the individual need and the milk, cultured milk, cream, fluid whey, and mixtures thereof. professional judgment of the person administering or Super Non-limiting examples of dairy analogue fluids which may vising the administration of the pharmaceutical composi be used in particular embodiments include, for example, Soy tions, and that the dosage ranges set forth herein are exem milk and non-dairy coffee whitener. Because edible gel prod plary only and are not intended to limit the scope or practice ucts found in the marketplace typically are Sweetened with of the claimed composition. The pharmaceutically active Sub sucrose, it is desirable to Sweetenedible gels with an alterna stance may be administered at once, or may be divided into a tive sweetener in order provide a low-calorie or non-calorie number of Smaller doses to be administered at varying inter alternative. vals of time. I0131. As used herein, the term “gelling ingredient’ 0.125. The pharmaceutical composition also may com denotes any material that can form a colloidal system within prise other pharmaceutically acceptable excipient materials. a liquid medium. Non-limiting examples of gelling ingredi Examples of suitable excipient materials for embodiments of ents for use in particular embodiments include gelatin, algi this invention include, but are not limited to, antiadherents, nate, carageenan, gum, pectin, konjac, agar, food acid, rennet, binders (e.g., microcrystalline cellulose, gum tragacanth, or starch, starch derivatives, and combinations thereof. It is well gelatin), coatings, disintegrants, fillers, diluents, softeners, known to those having ordinary skill in the art that the amount emulsifiers, flavoring agents, coloring agents, adjuvants, of gelling ingredient used in an edible gel mix or an edible gel lubricants, functional agents (e.g., nutrients), viscosity modi composition varies considerably depending on a number of fiers, bulking agents, glidiants (e.g., colloidal silicon dioxide) factors, such as the particular gelling ingredient used, the Surface active agents, osmotic agents, diluents, or any other particular fluid base used, and the desired properties of the non-active ingredient, or combinations thereof. For example, gel. the pharmaceutical compositions of the present invention 0.132. Non-limiting examples of other ingredients for use may include excipient materials selected from the group con in particular embodiments include a food acid, a salt of a food sisting of calcium carbonate, coloring agents, whiteners, pre acid, a buffering system, a bulking agent, a sequestrant, a servatives, and flavors, triacetin, magnesium Stearate, Ste cross-linking agent, one or more flavors, one or more colors, rotes, natural or artificial flavors, essential oils, plant extracts, and combinations thereof. Non-limiting examples of food fruit essences, gelatins, or combinations thereof. acids for use in particular embodiments include citric acid, 0126 The excipient material of the pharmaceutical com adipic acid, fumaric acid, lactic acid, malic acid, and combi position may optionally include other artificial or natural nations thereof. Non-limiting examples of salts of food acids sweeteners, bulk sweeteners, or combinations thereof. Bulk for use in particular embodiments include sodium salts of Sweeteners include both caloric and non-caloric compounds. food acids, potassium salts of food acids, and combinations In a particular embodiment, the additive functions as the bulk thereof. Non-limiting examples of bulking agents for use in sweetener. Non-limiting examples of bulk sweeteners include particular embodiments include raftilose, isomalt, Sorbitol, Sucrose, dextrose, maltose, dextrin, dried invert Sugar, fruc polydextrose, maltodextrin, and combinations thereof. Non tose, high fructose corn syrup, levulose, galactose, corn syrup limiting examples of sequestrants for use in particular Solids, tagatose, polyols (e.g., Sorbitol, mannitol, Xylitol, lac embodiments include calcium disodium ethylene tetra-ac titol, erythritol, and maltitol), hydrogenated Starch hydroly etate, glucono delta-lactone, sodium gluconate, potassium sates, isomalt, trehalose, and mixtures thereof. In particular gluconate, ethylenediaminetetraacetic acid (EDTA), and embodiments, the bulk Sweetener is present in the pharma combinations thereof. Non-limiting examples of cross-link ceutical composition in widely ranging amounts depending ing agents for use in particular embodiments include calcium on the degree of sweetness desired. Suitable amounts of both ions, magnesium ions, sodium ions, and combinations sweeteners would be readily discernible to those skilled in the thereof. art Dental Compositions 0127 Edible Gel Mixes and Edible Gel Compositions 0.133 0128. In one embodiment, the Sweetened composition is I0134. In one embodiment, the Sweetened composition is a an edible gel or edible gel mix. dental composition. 0129 Edible gels are gels that can be eaten. A gel is a 0.135 The dental composition may be in the form of any colloidal system in which a network of particles spans the oral composition used in the oral cavity Such as mouth fresh Volume of a liquid medium. Although gels mainly are com ening agents, gargling agents, mouth rinsing agents, tooth posed of liquids, and thus exhibit densities similar to liquids, paste, tooth polish, dentifrices, mouth sprays, teeth-whiten gels have the structural coherence of solids due to the network ing agent, dental floss, and the like, for example. of particles that spans the liquid medium. For this reason, gels 0.136. As referred to herein, “active dental substance' generally appear to be solid, jelly-like materials. Gels can be means any composition which can be used to improve the used in a number of applications. For example, gels can be aesthetic appearance and/or health ofteeth or gums or prevent used in foods, paints, and adhesives. dental caries. As referred to herein, “base material” refers to 0130 Non-limiting examples of edible gel compositions any inactive Substance used as a vehicle for an active dental for use in particular embodiments include gel desserts, pud Substance, such as any material to facilitate handling, stabil US 2015/0018432 A1 Jan. 15, 2015

ity, dispersibility, wettability, foaming, and/or release kinet position and the desired degree of sweetness. Those skilled in ics of an active dental Substance. the art will be able to discern a suitable amount of Sweetener 0137 Suitable active dental substances for embodiments for Such dental composition. of this invention include, but are not limited to, substances 014.4 Foodstuffs include, but are not limited to, confec which remove dental plaque, remove food from teeth, aid in tions, condiments, chewing gum, cereal, baked goods, and the elimination and/or masking of halitosis, prevent tooth dairy products. decay, and prevent gum disease (i.e., Gingiva). Examples of (0145 Confections suitable active dental substances for embodiments of the 0146 In one embodiment, the Sweetened composition is a present invention include, but are not limited to, anticaries confection. drugs, fluoride, Sodium fluoride, Sodium monofluorophos 0147 As referred to herein, “confection can mean a phate, Stannos fluoride, hydrogen peroxide, carbamide per Sweet, a lollie, a confectionery, or similar term. The confec oxide (i.e., urea peroxide), antibacterial agents, plaque tion generally contains a base composition component and a removing agents, stain removers, anticalculus agents, abra sweetener component. The confection may be in the form of sives, baking Soda, percarbonates, perborates of alkali and any food that is typically perceived to be rich in Sugar or is alkaline earth metals, or similar type Substances, or combi typically Sweet. According to particular embodiments of the nations thereof. Such components generally are recognized present invention, the confections may be bakery products as safe (GRAS) and/or are U.S. Food and Drug Administra Such as pastries; desserts such as yogurt, jellies, drinkable tion (FDA)-approved. jellies, puddings, Bavarian cream, blancmange, cakes, 0138 According to particular embodiments of the inven brownies, mousse and the like, Sweetened food products tion, the active dental Substance is present in the dental com eaten at tea time or following meals; frozen foods; cold con position in an amount ranging from about 50 ppm to about fections, e.g. types of ice cream Such as ice cream, ice milk, 3000 ppm of the dental composition. Generally, the active lacto-ice and the like (food products in which sweeteners and dental Substance is present in the dental composition in an various other types of raw materials are added to milk prod amount effective to at least improve the aesthetic appearance ucts, and the resulting mixture is agitated and frozen), and ice and/or health of teeth or gums marginally or prevent dental confections such as Sherbets, dessertices and the like (food caries. For example, a dental composition comprising a tooth products in which various other types of raw materials are paste may include an active dental Substance comprising fluo added to a Sugary liquid, and the resulting mixture is agitated ride in an amount of about 850 to 1,150 ppm. and frozen); general confections, e.g., baked confections or 0139. The dental composition also may comprise other steamed confections such as crackers, biscuits, buns with base materials. Examples of suitable base materials for bean-jam filling, halvah, alfajor, and the like; rice cakes and embodiments of this invention include, but are not limited to, Snacks; table top products; general Sugar confections such as water, Sodium lauryl Sulfate or other Sulfates, humectants, chewing gum (e.g. including compositions which comprise a enzymes, vitamins, herbs, calcium, flavorings (e.g., mint, Substantially water-insoluble, chewable gum base. Such as bubblegum, cinnamon, lemon, or orange), Surface-active chicle or Substitutes thereof, including jetulong, guttakay rub agents, binders, preservatives, gelling agents, pH modifiers, ber or certain comestible natural synthetic resins or waxes), peroxide activators, stabilizers, coloring agents, or similar hard candy, Soft candy, mints, nougat candy, jelly beans, type materials, and combinations thereof. fudge, toffee, taffy, Swiss milk tablet, licorice candy, choco 0140. The base material of the dental composition may lates, gelatin candies, marshmallow, marzipan, divinity, cot optionally include other artificial or natural sweeteners, bulk ton candy, and the like; sauces including fruit flavored sauces, sweeteners, or combinations thereof. Bulk sweeteners chocolate sauces and the like; edible gels; cremes including include both caloric and non-caloric compounds. Non-limit butter cremes, flour pastes, whipped cream and the like: jams ing examples of bulk Sweeteners include Sucrose, dextrose, including strawberry jam, marmalade and the like; and breads maltose, dextrin, dried invert Sugar, fructose, high fructose including Sweetbreads and the like or other starch products, corn Syrup, levulose, galactose, corn Syrup Solids, tagatose, and combinations thereof. polyols (e.g., Sorbitol, mannitol. Xylitol, lactitol, erythritol, 0.148. As referred to herein, “base composition” means and maltitol), hydrogenated Starch hydrolysates, isomalt, tre any composition which can be a food item and provides a halose, and mixtures thereof. matrix for carrying the Sweetener component. 0149 Suitable base compositions for embodiments of this 0141 Generally, the amount of bulk sweetener present in invention may include flour, yeast, water, salt, butter, eggs, the dental composition ranges widely depending on the par milk, milk powder, liquor, gelatin, nuts, chocolate, citric acid, ticular embodiment of the dental composition and the desired tartaric acid, fumaric acid, natural flavors, artificial flavors, degree of sweetness. Those of ordinary skill in the art will colorings, polyols, Sorbitol, isomalt, maltitol, lactitol, malic readily ascertain the appropriate amount of bulk Sweetener. In acid, magnesium Stearate, lecithin, hydrogenated glucose particular embodiments, the bulk sweetener is present in the syrup, glycerine, natural or synthetic gum, starch, and the dental composition in an amount in the range of about 0.1 to like, and combinations thereof. Such components generally about 5 weight percent of the dental composition. are recognized as safe (GRAS) and/or are U.S. Food and Drug 0142. According to particular embodiments of the inven Administration (FDA)-approved. According to particular tion, the base material is present in the dental composition in embodiments of the invention, the base composition is an amount ranging from about 20 to about 99 percent by present in the confection in an amount ranging from about 0.1 weight of the dental composition. Generally, the base mate to about 99 weight percent of the confection. rial is present in an amount effective to provide a vehicle for 0150. The base composition of the confection may option an active dental Substance. ally include other artificial or natural sweeteners, bulk sweet 0143 Generally, the amount of the sweetener varies eners, or combinations thereof. Bulk sweeteners include both widely depending on the nature of the particular dental com caloric and non-caloric compounds. Non-limiting examples US 2015/0018432 A1 Jan. 15, 2015

of bulk Sweeteners include Sucrose, dextrose, maltose, dex erally comprise a water-soluble portion and a water-insoluble trin, dried invert Sugar, fructose, high fructose corn Syrup, chewable gum base portion. The water soluble portion, which levulose, galactose, corn syrup Solids, tagatose, polyols (e.g., typically includes the rebaudioside X, dissipates with a por sorbitol, mannitol, xylitol, lactitol, erythritol, and maltitol), tion of the flavoring agent over a period of time during chew hydrogenated Starch hydrolysates, isomalt, trehalose, and ing while the insoluble gum base portion is retained in the mixtures thereof. Generally, the amount of bulk sweetener mouth. The insolublegum base generally determines whether present in the confection ranges widely depending on the a gum is considered chewing gum, bubblegum, or a func particular embodiment of the confection and the desired tional gum. degree of sweetness. Those of ordinary skill in the art will 0160 The insolublegum base, which is generally present readily ascertain the appropriate amount of bulk Sweetener. in the chewing gum composition in an amount in the range of 0151. In a particular embodiment, a confection comprises about 15 to about 35 weight percent of the chewing gum a non-rebaudioside X sweetener, rebaudioside X and a base composition, generally comprises combinations of elas composition. Those of ordinary skill in the art will readily tomers, softeners (plasticizers), emulsifiers, resins, and fill ascertain the appropriate amount of non-rebaudioside X ers. Such components generally are considered food grade, Sweetener. In a particular embodiment, the non-rebaudioside recognized as safe (GRA), and/or are U.S. Food and Drug X Sweetener is present in the confection in an amount in the Administration (FDA)-approved. range of about 30 ppm to about 6000 ppm of the confection. 0.161 Elastomers, the primary component of the gum 0152 Condiment Compositions base, provide the rubbery, cohesive nature to gums and can 0153. In one embodiment, the Sweetened composition is a include one or more natural rubbers (e.g., Smoked latex, liq condiment. uid latex, or guayule); natural gums (e.g., jelutong, perillo, 0154 Condiments, as used herein, are compositions used Sorva, massaranduba balata, massaranduba chocolate, nis to enhance or improve the flavor of a food or beverage. Non pero, rosindinha, chicle, and gutta hang kang); or synthetic limiting examples of condiments include ketchup (catsup); elastomers (e.g., butadiene-styrene copolymers, isobutylene mustard; barbecue sauce; butter, chili sauce; chutney; cock isoprene copolymers, polybutadiene, polyisobutylene, and tail sauce; curry; dips; fish sauce; horseradish: hot sauce; vinyl polymeric elastomers). In a particular embodiment, the jellies, jams, marmalades, or preserves; mayonnaise; peanut elastomer is present in the gum base in an amount in the range butter, relish; remoulade; salad dressings (e.g., oil and Vin of about 3 to about 50 weight percent of the gum base. egar, Caesar, French, ranch, bleu cheese, Russian, Thousand 0162 Resins are used to vary the firmness of the gum base Island, Italian, and balsamic vinaigrette), Salsa, Sauerkraut, and aid in softening the elastomer component of the gum soy sauce; steak sauce; syrups; tartar sauce; and Worcester base. Non-limiting examples of suitable resins include arosin shire sauce. ester, a terpene resin (e.g., a terpene resin from C-pinene, 0155 Condiment bases generally comprise a mixture of B-pinene and/or d-limonene), polyvinyl acetate, polyvinyl differentingredients, non-limiting examples of which include alcohol, ethylene vinyl acetate, and vinyl acetate-vinyl lau Vehicles (e.g., water and Vinegar); Spices or seasonings (e.g., rate copolymers. Non-limiting examples of rosin esters salt, pepper, garlic, mustard seed, onion, paprika, turmeric, include a glycerol ester of a partially hydrogenated rosin, a and combinations thereof); fruits, vegetables, or their prod glycerol ester of a polymerized rosin, a glycerol ester of a ucts (e.g., tomatoes or tomato-based products (paste, puree), partially dimerized rosin, a glycerol ester of rosin, a pen fruit juices, fruit juice peels, and combinations thereof); oils taerythritol ester of a partially hydrogenated rosin, a methyl or oil emulsions, particularly vegetable oils; thickeners (e.g., ester of rosin, or a methyl ester of a partially hydrogenated Xanthan gum, food starch, other hydrocolloids, and combina rosin. In a particular embodiment, the resin is present in the tions thereof); and emulsifying agents (e.g., egg yolk Solids, gum base in an amount in the range of about 5 to about 75 protein, gum arabic, carobbean gum, guar gum, gum karaya, weight percent of the gum base. gum tragacanth, carageenan, pectin, propylene glycol esters 0163 Softeners, which also are known as plasticizers, are of alginic acid, sodium carboxymethyl-cellulose, polysor used to modify the ease of chewing and/or mouthfeel of the bates, and combinations thereof). Recipes for condiment chewing gum composition. Generally, softeners comprise bases and methods of making condiment bases are well oils, fats, waxes, and emulsifiers. Non-limiting examples of known to those of ordinary skill in the art. oils and fats include tallow, hydrogenated tallow, large, 0156 Generally, condiments also comprise caloric Sweet hydrogenated or partially hydrogenated vegetable oils (e.g., eners. Such as Sucrose, high fructose corn syrup, molasses, Soybean, canola, cottonseed, Sunflower, palm, coconut, corn, honey, or brown Sugar. In exemplary embodiments of the safflower, or palm kernel oils), cocoa butter, glycerol condiments provided herein, rebaudioside X is used in addi monostearate, glycerol triacetate, glycerol abietate, leithin, tion to traditional caloric Sweeteners. Accordingly, a condi monoglycerides, diglycerides, triglycerides acetylated ment composition desirably comprises rebaudioside X, a monoglycerides, and free fatty acids. Non-limiting examples caloric Sweetener and a condiment base. of waxes include polypropylene/polyethylene/Fisher-Trop 0157. The condiment composition optionally may include sch waxes, paraffin, and microcrystalline and natural waxes other natural and/or synthetic high-potency Sweeteners, bulk (e.g., candelilla, beeswas and carnauba). Microcrystalline Sweeteners, pH modifying agents (e.g., lactic acid, citric acid, waxes, especially those with a high degree of crystallinity and phosphoric acid, hydrochloric acid, acetic acid, and combi a high melting point, also may be considered as bodying nations thereof), fillers, functional agents (e.g., pharmaceuti agents or textural modifiers. In a particular embodiment, the cal agents, nutrients, or components of a food or plant), fla softeners are present in the gum base in an amount in the Vorings, colorings, or combinations thereof. range of about 0.5 to about 25 weight percent of the gum base. 0158 Chewing Gum Compositions 0164. Emulsifiers are used to form a uniform dispersion of 0159. In one embodiment, the Sweetened composition is a the insoluble and soluble phases of the chewing gum compo chewing gum composition. Chewing gum compositions gen sition and also have plasticizing properties. Suitable emulsi US 2015/0018432 A1 Jan. 15, 2015

fiers include glycerol monostearate (GMS), lecithin (Phos 0170 In a particular embodiment, a chewing gum compo phatidylcholine), polyglycerol polyricinoleic acid (PPGR), sition comprises rebaudioside X, at least one caloric Sweet mono and diglycerides of fatty acids, glycerol distearate, ener and a gum base. tracetin, acetylated monoglyceride, glycerol triactetate, and 0171 Cereal Compositions magnesium Stearate. In a particular embodiment, the emulsi 0172. In one embodiment, the Sweetened composition is a fiers are present in the gum base in an amount in the range of cereal composition. Cereal compositions typically are eaten about 2 to about 30 weight percent of the gum base. either as staple foods or as Snacks. Non-limiting examples of cereal compositions for use in particular embodiments 0165. The chewing gum composition also may comprise include ready-to-eat cereals as well as hot cereals. Ready-to adjuvants or fillers in either the gum base and/or the soluble eat cereals are cereals which may be eaten without further portion of the chewing gum composition. Suitable adjuvants processing (i.e. cooking) by the consumer. Examples of and fillers include lecithin, inulin, polydextrin, calcium car ready-to-eat cereals include breakfast cereals and Snack bars. bonate, magnesium carbonate, magnesium silicate, ground Breakfast cereals typically are processed to produce a shred limestome, aluminum hydroxide, aluminum silicate, talc, ded, flaky, puffy, or extruded form. Breakfast cereals gener clay, alumina, titanium dioxide, and calcium phosphate. In ally are eaten cold and are often mixed with milk and/or fruit. particular embodiments, lecithin can be used as an inert filler Snack bars include, for example, energy bars, rice cakes, to decrease the Stickiness of the chewing gum composition. In granola bars, and nutritional bars. Hot cereals generally are other particular embodiments, lactic acid copolymers, pro cooked, usually in either milk or water, before being eaten. teins (e.g., gluten and/or Zein) and/or guar can be used to Non-limiting examples of hot cereals include grits, porridge, create a gum that is more readily biodegradable. The adju polenta, rice, and rolled oats. vants or fillers are generally present in the gum base in an 0173 Cereal compositions generally comprise at least one amount up to about 20 weight percent of the gum base. Other cerealingredient. As used herein, the term “cereal ingredient’ optional ingredients include coloring agents, whiteners, pre denotes materials such as whole or part grains, whole or part servatives, and flavors. seeds, and whole or part grass. Non-limiting examples of 0166 In particular embodiments of the chewing gum cereal ingredients for use in particular embodiments include composition, the gum base comprises about 5 to about 95 maize, wheat, rice, barley, bran, bran endosperm, bulgur, weight percent of the chewing gum composition, more desir Soghums, millets, oats, rye, triticale, buchwheat, fonio, ably about 15 to about 50 weight percent of the chewing gum quinoa, bean, Soybean, amaranth, teff, spelt, and kaniwa. composition, and even more desirably from about 20 to about (0174. In a particular embodiment, the cereal composition 30 weight percent of the chewing gum composition. comprises rebaudioside X, at least one caloric Sweetener and 0167. The soluble portion of the chewing gum composi at least one cereal ingredient. The rebaudioside X may be tion may optionally include other artificial or natural Sweet added to the cereal composition in a variety of ways, such as, eners, bulk Sweeteners, softeners, emulsifiers, flavoring for example, as a coating, as a frosting, as a glaze, or as a agents, coloring agents, adjuvants, fillers, functional agents matrix blend (i.e. added as an ingredient to the cereal formu (e.g., pharmaceutical agents or nutrients), or combinations lation prior to the preparation of the final cereal product). thereof. Suitable examples of softeners and emulsifiers are (0175 Baked Goods described above. 0176). In one embodiment, the Sweetened composition is a baked good. Baked goods, as used herein, include ready to eat 0168 Bulk sweeteners include both caloric and non-ca and all ready to bake products, flours, and mixes requiring loric compounds. Non-limiting examples of bulk Sweeteners preparation before serving. Non-limiting examples of baked include Sucrose, dextrose, maltose, dextrin, dried invert Sugar, goods include cakes, crackers, cookies, brownies, muffins, fructose, high fructose corn Syrup, levulose, galactose, corn rolls, bagels, donuts, strudels, pastries, croissants, biscuits, syrup Solids, tagatose, polyols (e.g., Sorbitol, mannitol. Xyli bread, bread products, and buns. tol, lactitol, erythritol, and maltitol), hydrogenated Starch 0177 Preferred baked goods in accordance with embodi hydrolysates, isomalt, trehalose, and mixtures thereof. In par ments of this invention can be classified into three groups: ticular embodiments, the bulk sweetener is present in the bread-type doughs (e.g., white breads, variety breads, soft chewing gum composition in an amount in the range of about buns, hard rolls, bagels, pizza dough, and flour tortillas), 1 to about 75 weight percent of the chewing gum composi Sweet doughs (e.g., danishes, croissants, crackers, puffpastry, tion. pie crust, biscuits, and cookies), and batters (e.g., cakes Such 0169 Flavoring agents may be used in either the insoluble as sponge, pound, devil's food, cheesecake, and layer cake, gum base or soluble portion of the chewing gum composition. donuts or other yeast raised cakes, brownies, and muffins). Such flavoring agents may be natural or artificial flavors. In a Doughs generally are characterized as being flour-based, particular embodiment, the flavoring agent comprises an whereas batters are more water-based. essential oil. Such as an oil derived from a plant or a fruit, 0.178 Baked goods in accordance with particular embodi peppermint oil, spearmint oil, other mint oils, clove oil, cin ments of this invention generally comprise a combination of namon oil, oil of wintergreen, bay, thyme, cedar leaf, nutmeg, Sweetener, water, and fat. Baked goods made in accordance allspice, Sage, mace, and almonds. In another particular with many embodiments of this invention also contain flourin embodiment, the flavoring agent comprises a plant extract or order to make a dough or a batter. The term "dough' as used a fruit essence Such as apple, banana, watermelon, pear, herein is a mixture of flour and other ingredients stiff enough peach, grape, Strawberry, raspberry, cherry, plum, pineapple, to knead or roll. The term “batter” as used herein consists of apricot, and mixtures thereof. In still another particular flour, liquids Such as milk or water, and other ingredients, and embodiment, the flavoring agent comprises a citrus flavor, is thin enough to pour or drop from a spoon. Desirably, in Such as an extract, essence, or oil of lemon, lime, orange, accordance with particular embodiments of the invention, the tangerine, grapefruit, citron, or kumquat. flour is present in the baked goods in an amount in the range US 2015/0018432 A1 Jan. 15, 2015

of about 15 to about 60% on a dry weight basis, more desir combinations thereof. In particular embodiments, the baked ably from about 23 to about 48% on a dry weight basis. goods may also comprise emulsifiers, such as lecithin and (0179 The type of flour may be selected based on the monoglycerides. desired product. Generally, the flour comprises an edible 0183. According to particular embodiments of this inven non-toxic flour that is conventionally utilized in baked goods. tion, leavening agents may comprise chemical leavening According to particular embodiments, the flour may be a agents or yeast leavening agents. Non-limiting examples of bleached bake flour, general purpose flour, or unbleached chemical leavening agents suitable for use in particular flour. In other particular embodiments, flours also may be embodiments of this invention include baking Soda (e.g., used that have been treated in other manners. For example, in Sodium, potassium, or aluminum bicarbonate), baking acid particular embodiments flour may be enriched with addi (e.g., Sodium aluminum phosphate, monocalcium phosphate, tional vitamins, minerals, or proteins. Non-limiting examples or dicalcium phosphate), and combinations thereof. of flours suitable for use in particular embodiments of the 0184. In accordance with another particular embodiment invention include wheat, corn meal, whole grain, fractions of of this invention, cocoa may comprise natural or “Dutched whole grains (wheat, bran, and oatmeal), and combinations chocolate from which a substantial portion of the fat or cocoa thereof. Starches or farinaceous material also may be used as butter has been expressed or removed by solvent extraction, the flour in particular embodiments. Common food starches pressing, or other means. In a particular embodiment, it may generally are derived from potato, corn, wheat, barley, oat, be necessary to reduce the amount of fat in a baked good tapioca, arrow root, and Sago. Modified Starches and prege comprising chocolate because of the additional fat present in latinized starches also may be used in particular embodiments cocoa butter. In particular embodiments, it may be necessary of the invention. to add larger amounts of chocolate as compared to cocoa in 0180. The type offat or oil used in particular embodiments order to provide an equivalent amount of flavoring and col of the invention may comprise any edible fat, oil, or combi nation thereof that is suitable for baking Non-limiting oring. examples of fats suitable for use in particular embodiments of 0185 Baked goods generally also comprise caloric sweet the invention include vegetable oils, tallow, lard, marine oils, eners, such as Sucrose, high fructose corn Syrup, erythritol, and combinations thereof. According to particular embodi molasses, honey, or brown Sugar. In exemplary embodiments ments, the fats may be fractionated, partially hydrogenated, of the baked goods provided herein, the caloric sweetener is and/or interesterified. In another particular embodiment, the Supplemented with rebaudioside X. Accordingly, in one fat desirably comprises reduced, low calorie, or non-digest embodiment a baked good comprises rebaudioside X, the ible fats, fat substitutes, or synthetic fats. In yet another par caloric Sweetener(s), fat, water, and optionally flour. In a ticular embodiment, shortenings, fats, or mixtures of hard and particular embodiment, the baked good optionally may Soft fats also may be used. In particular embodiments, short include other natural and/or synthetic high-potency Sweeten enings may be derived principally from triglycerides derived ers and/or bulk sweeteners. from vegetable sources (e.g., cotton seed oil, Soybean oil, 0186. Dairy Products peanut oil, linseed oil, sesame oil, palm oil, palm kernel oil, 0187. In one embodiment, the Sweetened composition is a rapeseed oil, safflower oil, coconut oil, corn oil, Sunflower dairy product. Dairy products and processes for making dairy seed oil, and mixtures thereof). Synthetic or natural triglyc products suitable for use in this invention are well known to erides offatty acids having chain lengths from 8 to 24 carbon those of ordinary skill in the art. Dairy products, as used atoms also may be used in particular embodiments. Desir herein, comprise milk or foodstuffs produced from milk. ably, in accordance with particular embodiments of this Non-limiting examples of dairy products Suitable for use in invention, the fat is present in the baked good in an amount in embodiments of this invention include milk, milk cream, Sour the range of about 2 to about 35% by weight on a dry basis, cream, creme fraiche, buttermilk, cultured buttermilk, milk more desirably from about 3 to about 29% by weight on a dry powder, condensed milk, evaporated milk, butter, cheese, basis. cottage cheese, cream cheese, yogurt, ice cream, frozen cus 0181 Baked goods in accordance with particular embodi tard, frozen yogurt, gelato, Vla, pima, filmjolk, kajmak, ments of this invention also comprise water in amounts Suf ficient to provide the desired consistency, enabling proper kephir, viili, kumiss, airag, ice milk, casein, ayran, lassi, khoa, forming, machining and cutting of the baked good prior or or combinations thereof. Subsequent to cooking. The total moisture content of the 0188 Milk is a fluid secreted by the mammary glands of baked good includes any water added directly to the baked female mammals for the nourishment of their young. The good as well as water present in separately added ingredients female ability to produce milk is one of the defining charac (e.g., flour, which generally includes about 12 to about 14% teristics of mammals and provides the primary source of by weight moisture). Desirably, in accordance with particular nutrition for newborns before they are able to digest more embodiments of this invention, the water is present in the diverse foods. In particular embodiments of this invention, baked good in an amount up to about 25% by weight of the the dairy products are derived from the raw milk of cows, baked good. goats, sheep, horses, donkeys, camels, water buffalo, yaks, 0182 Baked goods in accordance with particular embodi reindeer, moose, or humans. ments of this invention also may comprise a number of addi 0189 In particular embodiments of this invention, the pro tional conventional ingredients such as leavening agents, fla cessing of the dairy product from raw milk generally com Vors, colors, milk, milk by-products, egg, egg by-products, prises the steps of pasteurizing, creaming, and homogenizing. cocoa, Vanilla or other flavoring, as well as inclusions such as Although raw milk may be consumed without pasteurization, nuts, raisins, cherries, apples, apricots, peaches, other fruits, it usually is pasteurized to destroy harmful microorganisms citrus peel, preservative, coconuts, flavored chips such a Such as bacteria, viruses, protozoa, molds, and yeasts. Pas chocolate chips, butterscotch chips, and caramel chips, and teurizing generally comprises heating the milk to a high tem US 2015/0018432 A1 Jan. 15, 2015 perature for a short period of time to substantially reduce the invention, the dairy product comprises a dry creamer, a number of microorganisms, thereby reducing the risk of dis caloric sweetener and rebaudioside X. CaSC. 0194 In another particular embodiment, the dairy product 0190. Creaming traditionally follows pasteurization step, provided herein comprises butter. Butter generally is made by and involves the separation of milk into a higher-fat cream churning fresh or fermented cream or milk. Butter generally layer and a lower-fat milk layer. Milk will separate into milk comprises butterfat Surrounding Small droplets comprising and cream layers upon standing for twelve to twenty-four mostly water and milk proteins. The churning process dam hours. The cream rises to the top of the milk layer and may be ages the membranes Surrounding the microscopic globules of skimmed and used as a separate dairy product. Alternatively, butterfat, allowing the milk fats to conjoin and to separate centrifuges may be used to separate the cream from the milk. from the other parts of the cream. In yet another particular The remaining milk is classified according to the fat content embodiment, the dairy product comprises buttermilk, which of the milk, non-limiting examples of which include whole, is the Sour-tasting liquid remaining after producing butter 2%, 1%, and skim milk. from full-cream milk by the churning process. 0191 After removing the desired amount of fat from the 0.195. In still another particular embodiment, the dairy milk by creaming, milk is often homogenized. Homogeniza product comprises cheese, a solid foodstuff produced by cur tion prevents cream from separating from the milk and gen dling milk using a combination of rennet or rennet Substitutes erally involves pumping the milk at high pressures through and acidification. Rennet, a natural complex of enzymes pro narrow tubes in order to break up fat globules in the milk. duced in mammalian stomachs to digest milk, is used in Pasteurization, creaming, and homogenization of milk are cheese-making to curdle the milk, causing it to separate into common but are not required to produce consumable dairy Solids known as curds and liquids known as whey. Generally, products. Accordingly, Suitable dairy products for use in rennet is obtained from the stomachs of young ruminants, embodiments of this invention may undergo no processing Such as calves; however, alternative sources of rennet include steps, a single processing step, or combinations of the pro Some plants, microbial organisms, and genetically modified cessing steps described herein. Suitable dairy products foruse bacteria, fungus, or yeast. In addition, milk may be coagul in embodiments of this invention may also undergo process lated by adding acid, such as citric acid. Generally, a combi ing steps in addition to or apart from the processing steps nation of rennet and/or acidification is used to curdle the milk. described herein. After separating the milk into curds and whey, Some cheeses 0.192 Particular embodiments of this invention comprise are made by simply draining, salting, and packaging the dairy products produced from milk by additional processing curds. For most cheeses, however, more processing is needed. steps. As described above, cream may be skimmed from the Many different methods may be used to produce the hundreds top of milk or separated from the milk using machine-centri of available varieties of cheese. Processing methods include fuges. In a particular embodiment, the dairy product com heating the cheese, cutting it into Small cubes to drain, salting, prises sour cream, a dairy product rich in fats that is obtained stretching, cheddaring, Washing, molding, aging, and ripen by fermenting cream using a bacterial culture. The bacteria ing. Some cheeses, such as the blue cheeses, have additional produce lactic acid during fermentation, which sours and bacteria or molds introduced to them before or during aging, thickens the cream. In another particular embodiment, the imparting flavor and aroma to the finished product. Cottage dairy product comprises creme fraiche, a heavy cream cheese is a cheese curd product with a mild flavor that is slightly soured with bacterial culture in a similar manner to drained but not pressed so that Some whey remains. The curd sour cream. Creme fraiche ordinarily is not as thick or as sour is usually washed to remove acidity. Cream cheese is a soft, as sour cream. In yet another particular embodiment, the mild-tasting, white cheese with a high fat content that is dairy product comprises cultured buttermilk. Cultured butter produced by adding cream to milk and then curdling to form milk is obtained by adding bacteria to milk. The resulting a rich curd. Alternatively, cream cheese can be made from fermentation, in which the bacterial culture turns lactose into skim milk with cream added to the curd. It should be under lactic acid, gives cultured buttermilk a sour taste. Although it stood that cheese, as used herein, comprises all solid foodstuff is produced in a different manner, cultured buttermilk gener produced by the curdling milk. ally is similar to traditional buttermilk, which is a by-product 0196. In another particular embodiment of this invention, of butter manufacture. the dairy product comprises yogurt. Yogurt generally is pro 0193 According to other particular embodiments of this duced by the bacterial fermentation of milk. The fermentation invention, the dairy products comprise milk powder, con of lactose produces lactic acid, which acts on proteins in milk densed milk, evaporated milk, or combinations thereof. Milk to give the yogurt a gel-like texture and tartness. In particu powder, condensed milk, and evaporated milk generally are larly desirable embodiments, the yogurt may be sweetened produced by removing water from milk. In a particular with a sweetener and/or flavored. Non-limiting examples of embodiment, the dairy product comprises a milk powder flavorings include, but are not limited to, fruits (e.g., peach, comprising dried milk Solids with a low moisture content. In Strawberry, banana), Vanilla, and chocolate. Yogurt, as used another particular embodiment, the dairy product comprises herein, also includes yogurt varieties with different consis condensed milk. Condensed milk generally comprises milk tencies and Viscosities, such as dahi, dadih or dadiah, labneh with a reduced water content and added Sweetener, yielding a or labaneh, bulgarian, kefir, and matsoni. In another particular thick, Sweet product with a long shelf-life. In yet another embodiment, the dairy product comprises a yogurt-based particular embodiment, the dairy product comprises evapo beverage, also known as drinkable yogurt or a yogurt rated milk. Evaporated milk generally comprises fresh, Smoothie. In particularly desirable embodiments, the yogurt homogenized milk from which about 60% of the water has based beverage may comprise Sweeteners, flavorings, other been removed, that has been chilled, fortified with additives ingredients, or combinations thereof. Such as vitamins and stabilizers, packaged, and finally steril 0.197 Other dairy products beyond those described herein ized. According to another particular embodiment of this may be used in particular embodiments of this invention. US 2015/0018432 A1 Jan. 15, 2015

Such dairy products are well known to those of ordinary skill composition is a powdered beverage or syrup). The concen in the art, non-limiting examples of which include milk, milk trate composition enhances the Sweetness of the beverage by and juice, coffee, tea, Vla, pima, filmjolk, kajmak, kephir, an amount more than the detectable Sweetness of a solution vili, kumiss, airag, ice milk, casein, ayran, lassi, and khoa. containing the same concentration or rebaudioside X in the 0198 According to particular embodiments of this inven concentrate composition. tion, the dairy compositions also may comprise other addi 0205. In one embodiment, a concentrate composition tives. Non-limiting examples of suitable additives include comprises rebaudiosideX having a purity greater than about Sweeteners and flavorants such as chocolate, Strawberry, and 95% and at least one sweetener selected from the group banana. Particular embodiments of the dairy compositions consisting of Sucrose, fructose, glucose, high fructose corn provided herein also may comprise additional nutritional syrup, high fructose starch syrup, D-psicose, D-allose, Supplements such as vitamins (e.g., vitamin D) and minerals D-turanose, D-tagatose, D-trehalose, D-leucrose, rare Sugar (e.g., calcium) to improve the nutritional composition of the syrup or a combination thereof. The at least one Sweetener is milk. present in a concentration above its Sweetness recognition 0199 RebaudiosideX is also suitable for use in processed threshold once the concentrate composition is added to the agricultural products, livestock products or seafood; pro full-strength beverage (when the concentrate composition is a cessed meat products such as sausage and the like; retort food flavor packet or flavor enhancer drops) or once the concen products, pickles, preserves boiled in soy sauce, delicacies, trate composition is diluted to a full-strength beverage (when side dishes; Soups: Snacks such as potato chips, cookies, or the the concentrate composition is a powdered beverage or like; as shredded filler, leaf stem, stalk, homogenized leaf syrup). Rebaudioside X is present in a concentration at or cured and animal feed. below its Sweetness recognition threshold once the concen 0200 3. Concentrate Compositions trate composition is added to the full-strength beverage (when 0201 Rebaudioside X can also be provided in a concen the concentrate composition is a flavor packet or flavor trate composition. Suitable concentrate compositions enhancer drops) or once the concentrate composition is include, but are not limited to, syrups, powdered beverages, diluted to a full-strength beverage (when the concentrate flavor packets and flavor enhancer drops. composition is a powdered beverage or syrup). The concen 0202 Beverage syrups are prepared with an initial volume trate composition enhances the Sweetness of the beverage by of liquid matrix (e.g. water) and the desired beverage ingre at least about 1.0% (w/v) sucrose equivalence. dients. Full strength beverages are then prepared by adding 0206. The concentrate composition can further contain a further volumes of water. Powdered beverages are prepared liquid matrix, i.e. water, citric acid or phosphate buffer. by dry-mixing all of the beverage ingredients in the absence 0207. The concentrate composition can further contain of a liquid matrix. Full strength beverages are then prepared one or more functional ingredients, detailed below. Func by adding the full volume of water. Flavor packets and flavor tional ingredients include, but are not limited to, Vitamins, enhancer drops are often added to beverages (e.g. water) to minerals, antioxidants, preservatives, glucosamine, polyphe provide enhanced water, that is, for example, Sweeter, nutri nols and combinations thereof. Any Suitable functional ingre ent-enriched and/or fruit-flavored. dient described herein can be used. 0203. Accordingly, in one embodiment, a concentrate 0208. The concentrate composition can further contain composition comprising at least one Sweetener and rebaudio one or more additives including, but not limited to, carbohy side X is provided. When the concentrate composition is drates, polyols, amino acids and their corresponding salts, added to a beverage, the concentrate composition enhances poly-amino acids and their corresponding salts, Sugar acids the Sweetness of said beverage by an amount more than the and their corresponding salts, nucleotides, organic acids, detectable Sweetness of a solution containing the same con inorganic acids, organic salts including organic acid salts and centration of rebaudioside X in the concentrate composition. organic base salts, inorganic salts, bitter compounds, caf In another embodiment, the concentrate composition feine, flavorants and flavoring ingredients, astringent com enhances the sweetness of the beverage by at least about 1.0% pounds, proteins or protein hydrolysates, Surfactants, emul (w/v) Sucrose equivalence. sifiers, weighing agents, juice, dairy, cereal and other plant 0204. In one embodiment, a concentrate composition comprises rebaudiosideX having a purity greater than about extracts, flavonoids, alcohols, polymers and combinations 95% and at least one sweetener selected from the group thereof. Any suitable additive described herein can be used. consisting of Sucrose, fructose, glucose, high fructose corn 0209 4. Additives syrup, high fructose starch syrup, D-psicose, D-allose, 0210. The Sweetened compositions, beverages and/or D-turanose, D-tagatose, D-trehalose, D-leucrose, rare Sugar concentrate compositions of the present invention may syrup or a combination thereof. The at least one Sweetener is optionally include additional additives, detailed herein below. present in a concentration above its Sweetness recognition In some embodiments, the Sweetened compositions, bever threshold once the concentrate composition is added to the ages and/or concentrate compositions contains additives full-strength beverage (when the concentrate composition is a including, but not limited to, carbohydrates, polyols, amino flavor packet or flavor enhancer drops) or once the concen acids and their corresponding salts, poly-amino acids and trate composition is diluted to a full-strength beverage (when their corresponding salts, Sugar acids and their corresponding the concentrate composition is a powdered beverage or salts, nucleotides, organic acids, inorganic acids, organic salts syrup). Rebaudioside X is present in a concentration at or including organic acid salts and organic base salts, inorganic below its Sweetness recognition threshold once the concen salts, bitter compounds, flavorants and flavoring ingredients, trate composition is added to the full-strength beverage (when astringent compounds, proteins or protein hydrolysates, the concentrate composition is a flavor packet or flavor emulsifiers, weighing agents, gums, colorants, flavonoids, enhancer drops) or once the concentrate composition is alcohols, polymers, essential oils, anti-fungal agents and diluted to a full-strength beverage (when the concentrate combinations thereof. In some embodiments, the additives US 2015/0018432 A1 Jan. 15, 2015

act to improve the temporal and flavor profile of the Sweetener 0213 Suitable sugar acid additives include, but are not (s) to provide a taste similar to Sucrose. limited to, aldonic, uronic, aldaric, alginic, gluconic, glucu 0211 Suitable amino acid additives include, but are not ronic, glucaric, galactaric, galacturonic, and salts thereof limited to, aspartic acid, arginine, glycine, glutamic acid, (e.g., sodium, potassium, calcium, magnesium salts or other proline, threonine, theanine, cysteine, cystine, alanine, physiologically acceptable salts), and combinations thereof. Valine, tyrosine, leucine, arabinose, trans-4-hydroxyproline, 0214 Suitable nucleotide additives include, but are not isoleucine, asparagine, serine, lysine, histidine, ornithine, limited to, inosine monophosphate (IMP), guanosine methionine, carnitine, aminobutyric acid (Cl-, 3-, and/or monophosphate (“GMP), adenosine monophosphate 6-isomers), glutamine, hydroxyproline, taurine, norvaline, (AMP), cytosine monophosphate (CMP), uracil mono sarcosine, and their salt forms such as sodium or potassium phosphate (UMP), inosine diphosphate, guanosine diphos salts or acid salts. The amino acid additives also may be in the phate, adenosine diphosphate, cytosine diphosphate, uracil D- or L-configuration and in the mono-, di-, or tri-form of the diphosphate, inosine triphosphate, guanosine triphosphate, same or different amino acids. Additionally, the amino acids adenosine triphosphate, cytosine triphosphate, uracil triphos may be Cl-, 3-, y- and/or 6-isomers if appropriate. Combina phate, alkali or alkaline earth metal salts thereof, and combi tions of the foregoing amino acids and their corresponding nations thereof. The nucleotides described herein also may salts (e.g., Sodium, potassium, calcium, magnesium salts or comprise nucleotide-related additives, such as nucleosides or other alkali or alkaline earth metal salts thereof, or acid salts) nucleic acid bases (e.g., guanine, cytosine, adenine, thymine, also are Suitable additives in some embodiments. The amino uracil). acids may be natural or synthetic. The amino acids also may 0215. The nucleotide is present in an amount effective to be modified. Modified amino acids refers to any amino acid provide a concentration from about 5 ppm to about 1,000 ppm wherein at least one atom has been added, removed, Substi when present in Sweetened composition, Such as, for tuted, or combinations thereof (e.g., N-alkyl amino acid, example, a beverage. N-acyl amino acid, or N-methyl amino acid). Non-limiting examples of modified amino acids includeamino acid deriva 0216 Suitable organic acid additives include any com tives such as trimethylglycine, N-methyl-glycine, and N-me pound which comprises a —COOH moiety, such as, for thyl-alanine. As used herein, modified amino acids encom example, C2-C30 carboxylic acids, substituted hydroxyl pass both modified and unmodified amino acids. As used C2-C30 carboxylic acids, butyric acid (ethyl esters), substi herein, amino acids also encompass both peptides and tuted butyric acid (ethyl esters), benzoic acid, substituted polypeptides (e.g., dipeptides, tripeptides, tetrapeptides, and benzoic acids (e.g., 2,4-dihydroxybenzoic acid, 3-hydroxy pentapeptides) such as glutathione and L-alanyl-L- benzoic acid, 3,4,5-trihydroxybenzoic acid), substituted cin glutamine. Suitable polyamino acid additives include poly namic acids, hydroxyacids, Substituted hydroxybenzoic L-aspartic acid, poly-L-lysine (e.g., poly-L-C-lysine or poly acids, anisic acid substituted cyclohexyl carboxylic acids, L-e-lysine), poly-L-ornithine (e.g., poly-L-C-ornithine or tannic acid, aconitic acid, lactic acid, tartaric acid, citric acid, poly-L-e-ornithine), poly-L-arginine, other polymeric forms isocitric acid, gluconic acid, glucoheptonic acids, adipic acid, of amino acids, and salt forms thereof (e.g., calcium, potas hydroxycitric acid, malic acid, fruitaric acid (a blend of malic, sium, sodium, or magnesium salts such as L-glutamic acid fumaric, and tartaric acids), fumaric acid, maleic acid, Suc mono Sodium salt). The poly-amino acid additives also may cinic acid, chlorogenic acid, Salicylic acid, creatine, caffeic be in the D- or L-configuration. Additionally, the poly-amino acid, bile acids, acetic acid, ascorbic acid, alginic acid, ery acids may be Cl-, 3-, y-, 6-, and e-isomers if appropriate. thorbic acid, polyglutamic acid, glucono delta lactone, and Combinations of the foregoing poly-amino acids and their their alkali or alkaline earth metal salt derivatives thereof. In corresponding salts (e.g., Sodium, potassium, calcium, mag addition, the organic acid additives also may be in either the nesium salts or other alkali or alkaline earth metal salts D- or L-configuration. thereof or acid salts) also are suitable additives in some 0217 Suitable organic acid additive salts include, but are embodiments. The poly-amino acids described herein also not limited to, Sodium, calcium, potassium, and magnesium may comprise co-polymers of different amino acids. The salts of all organic acids, Such as salts of citric acid, malic poly-amino acids may be natural or synthetic. The poly acid, tartaric acid, fumaric acid, lactic acid (e.g., sodium amino acids also may be modified. Such that at least one atom lactate), alginic acid (e.g., sodium alginate), ascorbic acid has been added, removed, Substituted, or combinations (e.g., sodium ascorbate), benzoic acid (e.g., Sodium benzoate thereof (e.g., N-alkyl poly-amino acid or N-acyl poly-amino or potassium benzoate), Sorbic acid and adipic acid. The acid). As used herein, poly-amino acids encompass both examples of the organic acid additives described optionally modified and unmodified poly-amino acids. For example, may be substituted with at least one group chosen from hydro modified poly-amino acids include, but are not limited to, gen, alkyl, alkenyl, alkynyl, halo, haloalkyl, carboxyl, acyl, poly-amino acids of various molecular weights (MW), such acyloxy, amino, amido, carboxyl derivatives, alkylamino, as poly-L-O-lysine with a MW of 1,500, MW of 6,000, MW dialkylamino, arylamino, alkoxy, aryloxy, nitro, cyano, Sulfo, of 25,200, MW of 63,000, MW of 83,000, or MW of 300,000. thiol, imine, Sulfonyl, Sulfenyl, Sulfinyl, Sulfamyl, carbox 0212. In particular embodiments, the amino acid is present alkoxy, carboxamido, phosphonyl, phosphinyl, phosphoryl, in an amount effective to provide a concentration from about phosphino, thioester, thioether, anhydride, oximino, 10 ppm to about 50,000 ppm when present in a sweetened hydrazino, carbamyl, phosphor orphosphonato. In particular composition, Such as, for example, a beverage. In another embodiments, the organic acid additive is present in an embodiment, the amino acid is present in in an amount effec amount from about 10 ppm to about 5,000 ppm when present tive to provide a concentration from about 1,000 ppm to about in a Sweetened composition, such as, for example, a beverage. 10,000 ppm when present in a sweetened composition, such 0218 Suitable inorganic acid additives include, but are not as, for example, from about 2,500 ppm to about 5,000 ppm or limited to, phosphoric acid, phosphorous acid, polyphospho from about 250 ppm to about 7,500 ppm. ric acid, hydrochloric acid, Sulfuric acid, carbonic acid, US 2015/0018432 A1 Jan. 15, 2015

Sodium dihydrogen phosphate, and alkali or alkaline earth collagen (e.g., gelatin), partially hydrolyzed collagen (e.g., metal salts thereof (e.g., inositol hexaphosphate Mg/Ca). hydrolyzed fish collagen), and collagen hydrolysates (e.g., 0219. The inorganic acid additive is present in an amount porcine collagen hydrolysate). effective to provide a concentration from about 25 ppm to 0228. The protein hydrosylate is present in an amount about 25,000 ppm when present in a sweetened composition, effective to provide a concentration from about 200 ppm to Such as, for example, a beverage. about 50,000 ppm when present in a sweetened composition, 0220 Suitable bitter compound additives include, but are Such as, for example, a beverage. not limited to, caffeine, quinine, urea, bitter orange oil, nar 0229 Suitable flavonoid additives are classified as fla ingin, quassia, and salts thereof. Vonols, flavones, flavanones, flavan-3-ols, isoflavones, or 0221) The bitter compound is present in an amount effec anthocyanidins. Non-limiting examples of flavonoid addi tive to provide a concentration from about 25 ppm to about tives include, but are not limited to, catechins (e.g., green tea 25,000 ppm when present in a Sweetened composition, such extracts such as PolyphenonTM 60, PolyphenonTM 30, and as, for example, a beverage. PolyphenonTM25 (Mitsui Norin Co., Ltd., Japan), polyphe 0222 Suitable flavorant and flavoring ingredient additives nols, rutins (e.g., enzyme modified rutin SanmelinTM AO for include, but are not limited to, Vanillin, Vanilla extract, (San-fi Gen F.F.I., Inc., Osaka, Japan)), neohesperidin, narin mango extract, cinnamon, citrus, coconut, ginger, viridiflo gin, neohesperidin dihydrochalcone, and the like. rol, almond, menthol (including menthol without mint), 0230. The flavonoid additive is present in an amount effec grape skin extract, and grape seed extract. tive to provide a concentration from about 0.1 ppm to about 0223 “Flavorant' and “flavoring ingredient” are synony 1,000 ppm when present in Sweetened composition, such as, mous and can include natural or synthetic Substances or com for example, a beverage. binations thereof. Flavorants also include any other substance 0231 Suitable colorants include, but are not limited to, which imparts flavor and may include natural or non-natural caramel color, natural colors such as Annatto, cochineal, (synthetic) Substances which are safe for human or animals betanin, turmeric, paprika, Saffron, lycopene, elderberry when used in a generally accepted range. Non-limiting juice, pandan, yellow No. 6, yellow No. 5, red No. 40, Green examples of proprietary flavorants include DohlerTM Natural No. 3 and blue No. 1. Flavoring Sweetness Enhancer K14323 (DöhlerTM., Darms 0232 Suitable alcohol additives include, but are not lim tadt, Germany), SymriseTM Natural Flavor Mask for Sweet ited to, ethanol. In particular embodiments, the alcohol addi eners 161453 and 164126 (SymriseTM, Holzminden, Ger tive is present in the an amount effective to provide a concen many), Natural AdvantageTM Bitterness Blockers 1, 2, 9 and tration from about 625 ppm to about 10,000 ppm when 10 (Natural AdvantageTM, Freehold, N.J., U.S.A.), and Sucra present in a Sweetened composition, Such as, for example, a maskTM (Creative Research Management, Stockton, Calif., beverage. U.S.A.). 0233 Suitable astringent compound additives include, but 0224. The flavorant is present in an amount effective to are not limited to, tannic acid, europium chloride (EuCl). provide a concentration from about 0.1 ppm to about 5,000 gadolinium chloride (GdCl), terbium chloride (TbCl), ppm when present in a Sweetened composition, Such as, for alum, tannic acid, and polyphenols (e.g., tea polyphenols). example, a beverage. The astringent additive is present in an amount effective to 0225 Suitable polymer additives include, but are not lim provide a concentration from about 10 ppm to about 5,000 ited to, chitosan, pectin, pectic, pectinic, polyuronic, polyga ppm when present in a Sweetened composition, Such as, for lacturonic acid, starch, food hydrocolloid or crude extracts example, a beverage. thereof (e.g., gum acacia Senegal (FibergumTM), gum acacia 0234 Suitable essential oils include, but are not limited to, seyal, carageenan), poly-L-lysine (e.g., poly-L-C.-lysine or mustard oil, bitter orange and Sweet orange, menthe arvensis, poly-L-e-lysine), poly-L-ornithine (e.g., poly-L-C-ornithine peppermint, cedarwood, lemon, eucalyptus globulus, litsea or poly-L-e-ornithine), polypropylene glycol, polyethylene cubeba, clove and spearmint. glycol, poly(ethylene glycol methyl ether), polyarginine, pol 0235 Suitable anti-fungal agents include, but are not lim yaspartic acid, polyglutamic acid, polyethylene imine, alg ited to, Natamycin, amphotericin, anidulafungin, caspofun inic acid, Sodium alginate, propylene glycol alginate, and gin, fluconazole, itraconazole, micafungin, posaconazole, Sodium polyethyleneglycolalginate, Sodium hexametaphos Voriconazole, and flucytosine. phate and its salts, and other cationic polymers and anionic 0236. Other additives include typical beverages additives, polymers. i.e. glycerol ester of wood rosin, coconut oil, brominated 0226. The polymer is present in an amount effective to Vegetable oil, carob bean gum, Sucrose acetate isobutyrate, provide a concentration from about 30 ppm to about 2,000 modified food starch, Zinc gluconate and vitaminA palmitate. ppm when present in a Sweetened composition, Such as, for 0237) 5. Functional Ingredients example, a beverage. 0238. The sweetened composition can also contain one or 0227 Suitable protein or protein hydrolysate additives more functional ingredients, which provide a real or per include, but are not limited to, bovine serum albumin (BSA), ceived heath benefit to the composition. Functional ingredi whey protein (including fractions or concentrates thereof ents include, but are not limited to, antioxidants, dietary fiber such as 90% instant whey protein isolate, 34% whey protein, Sources, fatty acids, vitamins, glucosamine, minerals, preser 50% hydrolyzed whey protein, and 80% whey protein con Vatives, hydration agents, probiotics, prebiotics, weight man centrate), soluble rice protein, soy protein, protein isolates, agement agents, osteoporosis management agents, phy protein hydrolysates, reaction products of protein hydroly toestrogens, long chain primary aliphatic saturated alcohols, sates, glycoproteins, and/or proteoglycans containing amino phytosterols and combinations thereof. acids (e.g., glycine, alanine, serine, threonine, asparagine, 0239 Antioxidant glutamine, arginine, Valine, isoleucine, leucine, norvaline, 0240. In certain embodiments, the functional ingredient is methionine, proline, tyrosine, hydroxyproline, and the like), at least one antioxidant. Generally, according to particular US 2015/0018432 A1 Jan. 15, 2015

embodiments of this invention, the at least one antioxidant is are not limited to, fruits, vegetables, tea, cocoa, chocolate, present in the Sweetened composition, e.g. concentrate com spices, herbs, rice, organ meats from livestock, yeast, whole position or beverage, in an amount Sufficient to promote grains, or cereal grains. health and wellness. 0243 Particular antioxidants belong to the class of phyto nutrients called polyphenols (also known as “polypheno 0241. As used herein “antioxidant’ refers to any substance lics’), which are a group of chemical Substances found in which inhibits, suppresses, or reduces oxidative damage to plants, characterized by the presence of more than one phenol cells and biomolecules. Without being bound by theory, it is group per molecule. A variety of health benefits may derived believed that antioxidants inhibit, Suppress, or reduce oxida from polyphenols, including prevention of cancer, heart dis tive damage to cells or biomolecules by stabilizing free radi ease, and chronic inflammatory disease and improved mental cals before they can cause harmful reactions. As such, anti strength and physical strength, for example. Suitable oxidants may prevent or postpone the onset of some polyphenols for embodiments of this invention, include cat degenerative diseases. echins, proanthocyanidins, procyanidins, anthocyanins, 0242 Examples of suitable antioxidants for embodiments quercerin, rutin, reservatrol, isoflavones, curcumin, punicala of this invention include, but are not limited to, vitamins, gin, elagitannin, hesperidin, maringin, citrus flavonoids, Vitamin cofactors, minerals, hormones, carotenoids, caro chlorogenic acid, other similar materials, and combinations tenoid terpenoids, non-carotenoid terpenoids, flavonoids, fla thereof. vonoid polyphenolics (e.g., bioflavonoids), flavonols, fla 0244. In particular embodiments, the antioxidant is a cat Vones, phenols, polyphenols, esters of phenols, esters of echin Such as, for example, epigallocatechingallate (EGCG). polyphenols, nonflavonoid phenolics, isothiocyanates, and Suitable sources of catechins for embodiments of this inven tion include, but are not limited to, green tea, white tea, black combinations thereof. In some embodiments, the antioxidant tea, oolong tea, chocolate, cocoa, red wine, grape seed, red is vitaminA, Vitamin C, vitamin E., ubiquinone, mineral sele grape skin, purple grape skin, red grape juice, purple grape nium, manganese, melatonin, C-carotene, B-carotene, lyco juice, berries, pycnogenol, and red apple peel. pene, lutein, Zeanthin, crypoxanthin, reservatol, eugenol, 0245. In some embodiments, the antioxidant is chosen quercetin, catechin, gossypol, hesperetin, curcumin, ferulic from proanthocyanidins, procyanidins or combinations acid, thymol, hydroxytyrosol, tumeric, thyme, olive oil, lipoic thereof. Suitable sources of proanthocyanidins and procyani acid, glutathinone, gutamine, oxalic acid, tocopherol-derived dins for embodiments of this invention include, but are not compounds, butylated hydroxyanisole (BHA), butylated limited to, red grapes, purple grapes, cocoa, chocolate, grape hydroxytoluene (BHT), ethylenediaminetetraacetic acid seeds, red wine, cacao beans, cranberry, apple peel, plum, (EDTA), tert-butylhydroquinone, acetic acid, pectin, tocot blueberry, black currants, chokeberry, green tea, Sorghum, rienol, tocopherol, coenzyme Q10, Zeaxanthin, astaxanthin, cinnamon, barley, red kidney bean, pinto bean, hops, canthaxantin, Saponins, limonoids, kaempfedrol, myricetin, almonds, hazelnuts, pecans, pistachio, pycnogenol, and col isorhamnetin, proanthocyanidins, quercetin, rutin, luteolin, orful berries. apigenin, tangeritin, hesperetin, naringenin, erodictyol, fla 0246. In particular embodiments, the antioxidant is a van-3-ols (e.g., anthocyanidins), gallocatechins, epicatechin anthocyanin. Suitable sources of anthocyanins for embodi and its gallate forms, epigallocatechin and its gallate forms ments of this invention include, but are not limited to, red (ECGC) theaflavin and its gallate forms, thearubigins, isofla berries, blueberries, bilberry, cranberry, raspberry, cherry, Vone phytoestrogens, genistein, daidzein, glycitein, anytho pomegranate, Strawberry, elderberry, chokeberry, red grape cyanins, cyaniding, delphinidin, malvidin, pelargonidin, skin, purple grape skin, grape seed, red wine, black currant, peonidin, petunidin, ellagic acid, gallic acid, salicylic acid, red currant, cocoa, plum, apple peel, peach, red pear, red roSmarinic acid, cinnamic acid and its derivatives (e.g., feru cabbage, red onion, red orange, and blackberries. lic acid), chlorogenic acid, chicoric acid, gallotannins, ella 0247. In some embodiments, the antioxidant is chosen gitannins, anthoxanthins, betacyanins and other plant pig from quercetin, rutin or combinations thereof. Suitable ments, silymarin, citric acid, lignan, antinutrients, bilirubin, Sources of quercetin and rutin for embodiments of this inven uric acid, R-O-lipoic acid, N-acetylcysteine, emblicanin, tion include, but are not limited to, red apples, onions, kale, apple extract, apple skin extract (applephenon), rooibos bog whortleberry, lingonberrys, chokeberry, cranberry, extract red, rooibos extract, green, hawthornberry extract, red blackberry, blueberry, strawberry, raspberry, black currant, raspberry extract, green coffee antioxidant (GCA), aronia green tea, black tea, plum, apricot, parsley, leek, broccoli, extract 20%, grape seed extract (Vinoseed), cocoa extract, hops extract, mangosteen extract, mangosteen hull extract, chili pepper, berry wine, and ginkgo. cranberry extract, pomegranate extract, pomegranate hull 0248. In some embodiments, the antioxidant is resvera extract, pomegranate seed extract, hawthornberry extract, trol. Suitable sources of resveratrol for embodiments of this pomella pomegranate extract, cinnamon bark extract, grape invention include, but are not limited to, red grapes, peanuts, skin extract, bilberry extract, pine bark extract, pycnogenol, cranberry, blueberry, bilberry, mulberry, Japanese Itadori tea, elderberry extract, mulberry root extract, wolfberry (gogi) and red wine. extract, blackberry extract, blueberry extract, blueberry leaf 0249. In particular embodiments, the antioxidant is an extract, raspberry extract, turmeric extract, citrus biofla isoflavone. Suitable sources of isoflavones for embodiments vonoids, black currant, ginger, acai powder, green coffee bean of this invention include, but are not limited to, soybeans, soy extract, green tea extract, and phytic acid, or combinations products, legumes, alfalfa sprouts, chickpeas, peanuts, and thereof. In alternate embodiments, the antioxidant is a syn red clover. thetic antioxidant such as butylated hydroxytolune or buty (0250. In some embodiments, the antioxidant is curcumin. lated hydroxyanisole, for example. Other sources of suitable Suitable sources of curcumin for embodiments of this inven antioxidants for embodiments of this invention include, but tion include, but are not limited to, turmeric and mustard. US 2015/0018432 A1 Jan. 15, 2015

0251. In particular embodiments, the antioxidant is cho 0260 Waxes are esters of ethylene glycol and two fatty Sen from punicalagin, ellagitannin or combinations thereof. acids, generally occurring as a hydrophobic liquid that is Suitable sources of punicalagin and elagitannin for embodi insoluble in water. ments of this invention include, but are not limited to, pome 0261 Inulins comprise naturally occurring oligosaccha granate, raspberry, Strawberry, walnut, and oak-aged red rides belonging to a class of carbohydrates known as fructans. W1. They generally are comprised of fructose units joined by 0252. In some embodiments, the antioxidant is a citrus B(2-1) glycosidic linkages with a terminal glucose unit. Oli flavonoid, such as hesperidin or maringin. Suitable sources of gosaccharides are saccharide polymers containing typically citrus flavonids. Such as hesperidin or maringin, for embodi three to six component Sugars. They are generally found ments of this invention include, but are not limited to, either O- or N-linked to compatible amino acid side chains in oranges, grapefruits, and citrus juices. proteins or to lipid molecules. Fructooligosaccharides are 0253) In particular embodiments, the antioxidant is chlo oligosaccharides consisting of short chains of fructose mol rogenic acid. Suitable sources of chlorogenic acid for ecules. embodiments of this invention include, but are not limited to, 0262 Cyclodextrins are a family of cyclic oligosaccha green coffee, yerba mate, red wine, grape seed, red grape skin, rides composed of C-D-glucopyranoside units. They can be purple grape skin, red grape juice, purple grape juice, apple produced from starch by means of enzymatic conversion. juice, cranberry, pomegranate, blueberry, Strawberry, Sun C.-Cyclodextrin is a six Sugar ring molecule, whereas B- and flower, Echinacea, pycnogenol, and apple peel. Y-cyclodextrins have seven and eight Sugar ring molecules, respectively. Non-cyclic dextrins are known as maltodextrins 0254 Dietary Fiber and are generally easily digested by humans. Digestion resis 0255. In certain embodiments, the functional ingredient is tant maltodextrin is commercially available (e.g., Fibersol-2 at least one dietary fiber Source. Generally, according to par by ADM). ticular embodiments of this invention, the at least one dietary 0263 Food sources of dietary fiber include, but are not fiber Source is present in the Sweetened composition, e.g. limited to, grains, legumes, fruits, and vegetables. Grains concentrate composition or beverage, in an amount Sufficient providing dietary fiber include, but are not limited to, oats, to promote health and wellness. rye, barley, wheat. Legumes providing fiber include, but are 0256 Numerous polymeric carbohydrates having signifi not limited to, peas and beans such as soybeans. Fruits and cantly different structures in both composition and linkages Vegetables providing a source of fiber include, but are not fall within the definition of dietary fiber. Such compounds are limited to, apples, oranges, pears, bananas, berries, tomatoes, well known to those skilled in the art, non-limiting examples green beans, broccoli, cauliflower, carrots, potatoes, celery. of which include non-starch polysaccharides, lignin, cellu Plant foods such as bran, nuts, and seeds (such as flaxseeds) lose, methylcellulose, the hemicelluloses, B-glucans, pectins, are also sources of dietary fiber. Parts of plants providing gums, mucilage, waxes, inulins, oligosaccharides, fructooli dietary fiber include, but are not limited to, the stems, roots, gosaccharides, cyclodextrins, chitins, and combinations leaves, seeds, pulp, and skin. thereof. 0264. Although dietary fiber generally is derived from 0257 Polysaccharides are complex carbohydrates com plant sources, indigestible animal products such as chitins are posed of monosaccharides joined by glycosidic linkages. also classified as dietary fiber. Chitin is a polysaccharide Non-starch polysaccharides are bonded with B-linkages, composed of units of acetylglucosamine joined by B(1-4) which humans are unable to digest due to a lack of an enzyme linkages, similar to the linkages of cellulose. to break the B-linkages. Conversely, digestable starch 0265 Sources of dietary fiber often are divided into cat polysaccharides generally comprise C.(1-4) linkages. egories of soluble and insoluble fiber based on their solubility in water. Both soluble and insoluble fibers are found in plant 0258 Lignin is a large, highly branched and cross-linked foods to varying degrees depending upon the characteristics polymer based on oxygenated phenylpropane units. Cellu of the plant. Although insoluble in water, insoluble fiber has lose is a linear polymer of glucose molecules joined by a passive hydrophilic properties that help increase bulk, Soften B(1-4) linkage, which mammalian amylases are unable to stools, and shorten transit time of fecal Solids through the hydrolyze. Methylcellulose is a methyl esther of cellulose intestinal tract. that is often used in foodstuffs as a thickener, and emulsifier. 0266. Unlike insoluble fiber, soluble fiber readily dis It is commercially available (e.g., Citrucel by GlaxoSmith solves in water. Soluble fiber undergoes active metabolic Kline, Celevac by Shire Pharmaceuticals). Hemicelluloses processing via fermentation in the colon, increasing the are highly branched polymers consisting mainly of glucu colonic microflora and thereby increasing the mass of fecal rono- and 4-O-methylglucuroxylans. B-Glucans are mixed solids. Fermentation of fibers by colonic bacteria also yields linkage (1-3), (1-4)-D-glucose polymers found primarily in end-products with significant health benefits. For example, cereals, such as oats and barley. Pectins, such as beta pectin, fermentation of the food masses produces gases and short are a group of polysaccharides composed primarily of D-ga chain fatty acids. Acids produced during fermentation lacturonic acid, which is methoxylated to variable degrees. include butyric, acetic, propionic, and Valeric acids that have 0259 Gums and mucilages represent a broad array of dif various beneficial properties such as stabilizing blood glu ferent branched structures. Guar gum, derived from the cose levels by acting on pancreatic insulin release and pro ground endosperm of the guar seed, is a galactomannan. Guar viding liver control by glycogen breakdown. In addition, fiber gum is commercially available (e.g., Benefiber by Novartis fermentation may reduce atherosclerosis by lowering choles AG). Other gums, such as gum arabic and pectins, have still terol synthesis by the liver and reducing blood levels of LDL different structures. Still other gums include Xanthan gum, and triglycerides. The acids produced during fermentation gellan gum, tara gum, psylium seed husk gum, and locust lower colonic pH, thereby protecting the colon lining from been gum. cancer polyp formation. The lower colonic pH also increases

US 2015/0018432 A1 Jan. 15, 2015

0279. Glucosamine form. For example, Sulfur and phosphorous often are found 0280. In certain embodiments, the functional ingredient is naturally as Sulfates, sulfides, and phosphates. glucosamine. Generally, according to particular embodi 0290 Preservative ments of this invention, glucosamine is present in the Sweet 0291. In certain embodiments, the functional ingredient is ened composition, e.g. concentrate composition or beverage at least one preservative. Generally, according to particular in an amount Sufficient to promote health and wellness. embodiments of this invention, the at least one preservative is 0281 Glucosamine, also called chitosamine, is an amino present in the Sweetened composition, e.g. concentrate com Sugar that is believed to be an important precursor in the position or beverage, in an amount Sufficient to promote biochemical synthesis of glycosylated proteins and lipids. health and wellness. D-glucosamine occurs naturally in the cartilage in the form of 0292. In particular embodiments of this invention, the pre glucosamine-6-phosphate, which is synthesized from fruc servative is chosen from antimicrobials, antioxidants, antien tose-6-phosphate and glutamine. However, glucosamine also Zymatics or combinations thereof. Non-limiting examples of is available in other forms, non-limiting examples of which antimicrobials include Sulfites, propionates, benzoates, Sor include glucosamine hydrochloride, glucosamine Sulfate, bates, nitrates, nitrites, bacteriocins, salts, Sugars, acetic acid, N-acetyl-glucosamine, or any other salt forms or combina dimethyl dicarbonate (DMDC), ethanol, and ozone. tions thereof. Glucosamine may be obtained by acid hydroly 0293 According to a particular embodiment, the preser sis of the shells of lobsters, crabs, shrimps, or prawns using vative is a sulfite. Sulfites include, but are not limited to, sulfur methods well known to those of ordinary skill in the art. In a dioxide, Sodium bisulfite, and potassium hydrogen Sulfite. particular embodiment, glucosamine may be derived from 0294. According to another particular embodiment, the fungal biomass containing chitin, as described in U.S. Patent preservative is a propionate. Propionates include, but are not Publication No. 2006/0172392. limited to, propionic acid, calcium propionate, and Sodium 0282. The Sweetened composition can further comprise propionate. chondroitin sulfate. 0295 According to yet another particular embodiment, 0283 Mineral the preservative is a benzoate. Benzoates include, but are not 0284. In certain embodiments, the functional ingredient is limited to, sodium benzoate and benzoic acid. at least one mineral. Generally, according to particular 0296. In another particular embodiment, the preservative embodiments of this invention, the at least one mineral is is a sorbate. Sorbates include, but are not limited to, potas present in the Sweetened composition, e.g. concentrate com sium Sorbate, sodium Sorbate, calcium Sorbate, and Sorbic position or beverage, in an amount Sufficient to promote acid. health and wellness. 0297. In still another particular embodiment, the preser 0285 Minerals, in accordance with the teachings of this vative is a nitrate and/or a nitrite. Nitrates and nitrites include, invention, comprise inorganic chemical elements required by but are not limited to, Sodium nitrate and Sodium nitrite. living organisms. Minerals are comprised of a broad range of 0298. In yet another particular embodiment, the at least compositions (e.g., elements, simple salts, and complex sili one preservative is a bacteriocin, Such as, for example, nisin. cates) and also vary broadly in crystalline structure. They may 0299. In another particular embodiment, the preservative naturally occur in foods and beverages, may be added as a is ethanol. Supplement, or may be consumed or administered separately 0300. In still another particular embodiment, the preser from foods or beverages. Vative is OZone. 0286 Minerals may be categorized as either bulk miner 0301 Non-limiting examples of antienzymatics suitable als, which are required in relatively large amounts, or trace for use as preservatives in particular embodiments of the minerals, which are required in relatively small amounts. invention include ascorbic acid, citric acid, and metal chelat Bulk minerals generally are required in amounts greater than ing agents such as ethylenediaminetetraacetic acid (EDTA). or equal to about 100 mg per day and trace minerals are those 0302 Hydration Agent that are required in amounts less than about 100 mg per day. 0303. In certain embodiments, the functional ingredient is 0287. In particular embodiments of this invention, the at least one hydration agent. Generally, according to particu mineral is chosen from bulk minerals, trace minerals or com lar embodiments of this invention, the at least one hydration binations thereof. Non-limiting examples of bulk minerals agent is present in the Sweetened composition, e.g. concen include calcium, chlorine, magnesium, phosphorous, potas trate composition or beveage, in an amount Sufficient to pro sium, Sodium, and Sulfur. Non-limiting examples of trace mote health and wellness. minerals include chromium, cobalt, copper, fluorine, iron, 0304 Hydration products help the body to replace fluids manganese, molybdenum, selenium, Zinc, and iodine. that are lost through excretion. For example, fluid is lost as Although iodine generally is classified as a trace mineral, it is Sweat in order to regulate body temperature, as urine in order required in larger quantities than other trace minerals and to excrete waste Substances, and as water vapor in order to often is categorized as a bulk mineral. exchange gases in the lungs. Fluid loss can also occur due to 0288. In other particular embodiments of this invention, a wide range of external causes, non-limiting examples of the mineral is a trace mineral, believed to be necessary for which include physical activity, exposure to dry air, diarrhea, human nutrition, non-limiting examples of which include Vomiting, hyperthermia, shock, blood loss, and hypotension. bismuth, boron, lithium, nickel, rubidium, silicon, strontium, Diseases causing fluid loss include diabetes, cholera, gastro tellurium, tin, titanium, tungsten, and Vanadium. enteritis, shigellosis, and yellow fever. Forms of malnutrition 0289. The minerals embodied herein may be in any form that cause fluid loss include the excessive consumption of known to those of ordinary skill in the art. For example, in a alcohol, electrolyte imbalance, fasting, and rapid weight loss. particular embodiment the minerals may be in their ionic 0305. In a particular embodiment, the hydration product is form, having either a positive or negative charge. In another a composition that helps the body replace fluids that are lost particular embodiment the minerals may be in their molecular during exercise. Accordingly, in a particular embodiment, the US 2015/0018432 A1 Jan. 15, 2015 22 hydration product is an electrolyte, non-limiting examples of 0311 Probiotics, in accordance with the teachings of this which include Sodium, potassium, calcium, magnesium, invention, comprise microorganisms that benefit health when chloride, phosphate, bicarbonate, and combinations thereof. consumed in an effective amount. Desirably, probiotics ben Suitable electrolytes for use in particular embodiments of this eficially affect the human body's naturally-occurring gas invention are also described in U.S. Pat. No. 5,681,569, the trointestinal microflora and impart health benefits apart from disclosure of which is expressly incorporated herein by ref nutrition. Probiotics may include, without limitation, bacte erence. In particular embodiments, the electrolytes are ria, yeasts, and fungi. obtained from their corresponding water-soluble salts. Non 0312. According to particular embodiments, the probiotic limiting examples of salts for use in particular embodiments is a beneficial microorganisms that beneficially affects the include chlorides, carbonates, Sulfates, acetates, bicarbon human body's naturally-occurring gastrointestinal microf ates, citrates, phosphates, hydrogen phosphates, tartates, Sor lora and imparts health benefits apart from nutrition. bates, citrates, benzoates, or combinations thereof. In other Examples of probiotics include, but are not limited to, bacte embodiments, the electrolytes are provided by juice, fruit ria of the genus Lactobacilli, Bifidobacteria, Streptococci, or extracts, vegetable extracts, tea, or teas extracts. combinations thereof, that confer beneficial effects to 0306 In particular embodiments of this invention, the humans. hydration product is a carbohydrate to Supplement energy 0313. In particular embodiments of the invention, the at stores burned by muscles. Suitable carbohydrates for use in least one probiotic is chosen from the genus Lactobacili. particular embodiments of this invention are described in Lactobacilli (i.e., bacteria of the genus Lactobacillus, here U.S. Pat. Nos. 4.312,856, 4,853,237, 5,681,569, and 6,989, inafter “L”) have been used for several hundred years as a 171, the disclosures of which are expressly incorporated food preservative and for promoting human health. Non herein by reference. Non-limiting examples of suitable car limiting examples of species of Lactobacili found in the bohydrates include monosaccharides, disaccharides, oli human intestinal tract include L. acidophilus, L. casei, L. gosaccharides, complex polysaccharides or combinations fermentum, L. Saliva roes, L. brevis, L. leichmannii, L. plan thereof. Non-limiting examples of suitable types of monosac tarum, L. cellobiosus, L. reuteri, L. rhamnosus, L. GG, L. charides for use in particular embodiments include trioses, bulgaricus, and L. thermophilus. tetroses, pentoses, hexoses, heptoses, octoses, and nonoses. 0314. According to other particular embodiments of this Non-limiting examples of specific types of suitable monosac invention, the probiotic is chosen from the genus Bifidobac charides include glyceraldehyde, dihydroxyacetone, eryth teria. Bifidobacteria also are known to exert a beneficial rose, threose, erythrulose, arabinose, lyxose, ribose, xylose, influence on human health by producing short chain fatty ribulose, Xylulose, allose, altrose, galactose, glucose, gulose, acids (e.g., acetic, propionic, and butyric acids), lactic, and idose, mannose, talose, fructose, psicose, Sorbose, tagatose, formic acids as a result of carbohydrate metabolism. Non mannoheptulose, Sedoheltulose, octolose, and sialose. Non limiting species of Bifidobacteria found in the human gas limiting examples of Suitable disaccharides include Sucrose, trointestinal tract include B. angulatum, B. animalis, B. aster lactose, and maltose. Non-limiting examples of Suitable oli oides, B. bifidum, B. bourn, B. breve, B. catenulatum, B. gosaccharides include saccharose, maltotriose, and malto choerinum, B. Coryneforme, B. cuniculi, B. dentium, B. gal dextrin. In other particular embodiments, the carbohydrates licum, B. gallinarum, B indicum, B. longum, B. magnum, B. are provided by a corn Syrup, a beet Sugar, a cane Sugar, a merycicum, B. minimum, B. pseudocatenulatum, B. juice, or a tea. pseudolongum, B. psychraerophilum, B. pullorum, B. rumi 0307. In another particular embodiment, the hydration is a nantium, B. saeculare, B. scardovii, B. Simiae, B. subtile, B. flavanol that provides cellular rehydration. Flavanols are a thermacidophilum, B. thermophilum, B. urinalis, and B. sp. class of natural Substances present in plants, and generally 0315 According to other particular embodiments of this comprise a 2-phenylbenzopyrone molecular skeleton invention, the probiotic is chosen from the genus Streptococ attached to one or more chemical moieties. Non-limiting cus. Streptococcus thermophilus is a gram-positive faculta examples of suitable flavanols for use in particular embodi tive anaerobe. It is classified as a lactic acid bacteria and ments of this invention include catechin, epicatechin, gallo commonly is found in milk and milk products, and is used in catechin, epigallocatechin, epicatechin gallate, epigallocat the production of yogurt. Other non-limiting probiotic spe echin 3-gallate, theaflavin, theaflavin 3-gallate, theaflavin cies of this bacteria include Streptococcus salivarus and 3'-gallate, theaflavin3.3' gallate, thearubigin or combinations Streptococcus Cremoris. thereof. Several common sources of flavanols include tea 0316 Probiotics that may be used in accordance with this plants, fruits, vegetables, and flowers. In preferred embodi invention are well-known to those of skill in the art. Non ments, the flavanol is extracted from green tea. limiting examples of foodstuffs comprising probiotics 0308. In a particular embodiment, the hydration product is include yogurt, Sauerkraut, kefir, kimchi, fermented veg a glycerol Solution to enhance exercise endurance. The inges etables, and other foodstuffs containing a microbial element tion of a glycerol containing solution has been shown to that beneficially affects the host animal by improving the provide beneficial physiological effects, such as expanded intestinal microbalance. blood volume, lower heart rate, and lower rectal temperature. 0317 Prebiotics, in accordance with the teachings of this 0309 Probiotics/Prebiotics invention, are compositions that promote the growth of ben 0310. In certain embodiments, the functional ingredient is eficial bacteria in the intestines. Prebiotic substances can be chosen from at least one probiotic, prebiotic and combination consumed by a relevant probiotic, or otherwise assist in keep thereof. Generally, according to particular embodiments of ing the relevant probiotic alive or stimulate its growth. When this invention, the at least one probiotic, prebiotic or combi consumed in an effective amount, prebiotics also beneficially nation thereof is present in the Sweetened composition, e.g. affect the human body's naturally-occurring gastrointestinal concentrate composition or beverage, in an amount Sufficient microflora and thereby impart health benefits apart from just to promote health and wellness. nutrition. Prebiotic foods enter the colon and serve as sub US 2015/0018432 A1 Jan. 15, 2015 strate for the endogenous bacteria, thereby indirectly provid (CCK), while consumption of carbohydrates and dietary fats ing the host with energy, metabolic Substrates, and essential stimulates release of Glucagon-like peptide 1 (GLP-1). micronutrients. The body's digestion and absorption of pre 0326 Suitable macronutrient weight management agents biotic foods is dependent upon bacterial metabolic activity, also include carbohydrates. Carbohydrates generally com which salvages energy for the host from nutrients that prise Sugars, starches, cellulose and gums that the body con escaped digestion and absorption in the Small intestine. verts into glucose for energy. Carbohydrates often are classi 0318 Prebiotics, in accordance with the embodiments of fied into two categories, digestible carbohydrates (e.g., this invention, include, without limitation, mucopolysaccha monosaccharides, disaccharides, and starch) and non-digest rides, oligosaccharides, polysaccharides, amino acids, Vita ible carbohydrates (e.g., dietary fiber). Studies have shown mins, nutrient precursors, proteins and combinations thereof. that non-digestible carbohydrates and complex polymeric 0319. According to a particular embodiment of this inven carbohydrates having reduced absorption and digestibility in tion, the prebiotic is chosen from dietary fibers, including, the Small intestine stimulate physiologic responses that without limitation, polysaccharides and oligosaccharides. inhibit food intake. Accordingly, the carbohydrates embodied These compounds have the ability to increase the number of herein desirably comprise non-digestible carbohydrates or probiotics, which leads to the benefits conferred by the pro carbohydrates with reduced digestibility. Non-limiting biotics. Non-limiting examples of oligosaccharides that are examples of such carbohydrates include polydextrose; inulin; categorized as prebiotics in accordance with particular monosaccharide-derived polyols such as erythritol, mannitol, embodiments of this invention include fructooligosaccha xylitol, and sorbitol; disaccharide-derived alcohols such as rides, inulins, isomalto-oligosaccharides, lactilol, lactosu isomalt, lactitol, and maltitol; and hydrogenated Starch crose, lactulose, pyrodextrins, soy oligosaccharides, transga hydrolysates. Carbohydrates are described in more detail lacto-oligosaccharides, and Xylo-oligosaccharides. herein below. 0320 According to other particular embodiments of the 0327. In another particular embodiment weight manage invention, the prebiotic is an amino acid. Although a number ment agents is dietary fat. Dietary fats are lipids comprising of known prebiotics breakdown to provide carbohydrates for combinations of Saturated and unsaturated fatty acids. Poly probiotics, some probiotics also require amino acids for nour unsaturated fatty acids have been shown to have a greater satiating power than mono-unsaturated fatty acids. Accord ishment. ingly, the dietary fats embodied herein desirably comprise 0321 Prebiotics are found naturally in a variety of foods poly-unsaturated fatty acids, non-limiting examples of which including, without limitation, bananas, berries, asparagus, include triacylglycerols. garlic, wheat, oats, barley (and other whole grains), flaxseed, 0328. In a particular embodiment, the weight management tomatoes, Jerusalem artichoke, onions and chicory, greens agents is an herbal extract. Extracts from numerous types of (e.g., dandelion greens, spinach, collard greens, chard, kale, plants have been identified as possessing appetite Suppressant mustard greens, turnip greens), and legumes (e.g., lentils, properties. Non-limiting examples of plants whose extracts kidney beans, chickpeas, navy beans, white beans, black have appetite Suppressant properties include plants of the beans). genus Hoodia, Trichocaulon, Caraluma, Stapelia, Orbea, 0322 Weight Management Agent Asclepias, and Camelia. Other embodiments include extracts 0323. In certain embodiments, the functional ingredient is derived from Gymnema Sylvestre, Kola Nut, Citrus Auran at least one weight management agent. Generally, according tium, Yerba Mate, Griffonia Simplicifolia, Guarana, myrrh, to particular embodiments of this invention, the at least one guggul Lipid, and black current seed oil. weight management agent is present in the Sweetened com 0329. The herbal extracts may be prepared from any type position, e.g. concentrate composition or beverage, in an of plant material or plant biomass. Non-limiting examples of amount Sufficient to promote health and wellness. plant material and biomass include the stems, roots, leaves, 0324 AS used herein, “a weight management agent' dried powder obtained from the plant material, and sap or includes an appetite Suppressant and/or a thermogenesis dried sap. The herbal extracts generally are prepared by agent. As used herein, the phrases “appetite Suppressant'. extracting sap from the plant and then spray-drying the sap. “appetite satiation compositions”, “satiety agents', and “sati Alternatively, Solvent extraction procedures may be ety ingredients' are synonymous. The phrase “appetite Sup employed. Following the initial extraction, it may be desir pressant describes macronutrients, herbal extracts, exog able to further fractionate the initial extract (e.g., by column enous hormones, anorectics, anorexigenics, pharmaceutical chromatography) in order to obtain an herbal extract with drugs, and combinations thereof, that when delivered in an enhanced activity. Such techniques are well known to those of effective amount, Suppress, inhibit, reduce, or otherwise cur ordinary skill in the art. tail a person's appetite. The phrase “thermogenesis agent' 0330. In a particular embodiment, the herbal extract is describes macronutrients, herbal extracts, exogenous hor derived from a plant of the genus Hoodia, species of which mones, anorectics, anorexigenics, pharmaceutical drugs, and include H. alstonii, H. currorii, H. dregei, H. flava, H. gor combinations thereof, that when delivered in an effective donii, H.jutatae, H. mossamedensis, H. officinalis, H. parvi amount, activate or otherwise enhance a persons thermogen florai, H. pedicellata, H. pilifera, H. ruschii, and H. triebneri. esis or metabolism. Hoodia plants are stem Succulents native to Southern Africa. 0325 Suitable weight management agents include macro A sterol glycoside of Hoodia, known as P57, is believed to be nutrient selected from the group consisting of proteins, car responsible for the appetite-suppressant effect of the Hoodia bohydrates, dietary fats, and combinations thereof. Con species. Sumption of proteins, carbohydrates, and dietary fats 0331. In another particular embodiment, the herbal extract stimulates the release of peptides with appetite-suppressing is derived from a plant of the genus Caralluma, species of effects. For example, consumption of proteins and dietary fats which include C. indica, C. fimbriata, C. attenuate, C. tuber stimulates the release of the gut hormone cholecytokinin culate, C. edulis, C. adscendens, C. Stalagmifera, C. umbel US 2015/0018432 A1 Jan. 15, 2015 24 late, C. penicillata, C. russeliana, C. retrospicens, C. Ara particular embodiment, the calcium source is any compound bica, and C. lasiantha. Carraluma plants belong to the same containing calcium, including salt complexes, Solubilized Subfamily as Hoodia, Asclepiadaceae. Caraluma are Small, species, and other forms of calcium. Non-limiting examples erect and fleshy plants native to India having medicinal prop of calcium sources include amino acid chelated calcium, cal erties, such as appetite Suppression, that generally are attrib cium carbonate, calcium oxide, calcium hydroxide, calcium uted to glycosides belonging to the pregnane group of glyco Sulfate, calcium chloride, calcium phosphate, calcium hydro sides, non-limiting examples of which include caratuberside gen phosphate, calcium dihydrogen phosphate, calcium cit A, caratuberside B, bouceroside I, bouceroside II, bouceros rate, calcium malate, calcium citrate malate, calcium glucon ide III, bouceroside IV, bouceroside V, bouceroside VI, bouc ate, calcium tartrate, calcium lactate, solubilized species eroside VII, bouceroside VIII, bouceroside IX, and boucero thereof, and combinations thereof. side X. 0342. According to a particular embodiment, the 0332. In another particular embodiment, the at least one osteoporosis management agent is a magnesium source. The herbal extract is derived from a plant of the genus Trichocau magnesium source is any compound containing magnesium, lon. Trichocaulon plants are succulents that generally are including salt complexes, Solubilized species, and other native to Southern Africa, similar to Hoodia, and include the forms of magnesium. Non-limiting examples of magnesium species T. piliferum and T. officinale. Sources include magnesium chloride, magnesium citrate, 0333. In another particular embodiment, the herbal extract magnesium gluceptate, magnesium gluconate, magnesium is derived from a plant of the genus Stapelia or Orbea, species hydroxide, magnesium picolate, magnesium sulfate, solubi of which include S. gigantean and O. variegate, respectively. lized species thereof, and mixtures thereof. In another par Both Stapelia and Orbea plants belong to the same Subfamily ticular embodiment, the magnesium source comprises an as Hoodia, Asclepiadaceae. Not wishing to be bound by any amino acid chelated or creatine chelated magnesium. theory, it is believed that they compounds exhibiting appetite 0343. In other embodiments, the osteoporosis agent is Suppressant activity are Saponins. Such as pregnane glyco chosen from vitamins D, C, K, their precursors and/or beta sides, which include stavarosides A, B, C, D, E, F, G, H, I, J. carotene and combinations thereof. and K. 0344) Numerous plants and plant extracts also have been 0334. In another particular embodiment, the herbal extract identified as being effective in the prevention and treatment of is derived from a plant of the genus Asclepias. Asclepias osteoporosis. Not wishing to be bound by any theory, it is plants also belong to the Asclepiadaceae family of plants. believed that the plants and plant extracts stimulates bone Non-limiting examples of Asclepias plants include A. incar morphogenic proteins and/or inhibits bone resorption, nate, A. curassavica, A. Syriaca, and A. tuberose. Not wishing thereby stimulating bone regeneration and strength. Non to be bound by any theory, it is believed that the extracts limiting examples of Suitable plants and plant extracts as comprise steroidal compounds, such as pregnane glycosides osteoporosis managementagents include species of the genus and pregnane aglycones, having appetite Suppressant effects. Taraxacum and Amelanchier, as disclosed in U.S. Patent Pub 0335. In a particular embodiment, the weight management lication No. 2005/0106215, and species of the genus Lindera, agent is an exogenous hormone having a weight management Artemisia, Acorus, Carthamus, Carum, Cnidium, Curcuma, effect. Non-limiting examples of Such hormones include Cyperus, Juniperus, Prunus, Iris, Cichorium, Dodonaea, CCK, peptide YY. ghrelin, bombesin and gastrin-releasing Epimedium, Erigonoum, Soya, Mentha, Ocimum, thymus, peptide (GRP), enterostatin, apolipoprotein A-IV, GLP-1. Tanacetum, Plantago, Spearmint, Bixa, Vitis, Rosemarinus, amylin, Somastatin, and leptin. Rhus, and Anethum, as disclosed in U.S. Patent Publication 0336. In another embodiment, the weight management No. 2005/OO79232. agent is a pharmaceutical drug. Non-limiting examples (0345 Phytoestrogen include phentenime, diethylpropion, phendimetrazine, 0346. In certain embodiments, the functional ingredient is Sibutramine, rimonabant, oxyntomodulin, floxetine hydro at least one phytoestrogen. Generally, according to particular chloride, ephedrine, phenethylamine, or other stimulants. embodiments of this invention, the at least one phytoestrogen 0337 The at least one weight management agent may be is present in the Sweetened composition, e.g. concentrate utilized individually or in combination as a functional ingre composition or beverage, in an amount Sufficient to promote dient for the sweetened compositions provided in this inven health and wellness. tion. 0347 Phytoestrogens are compounds found in plants 0338 Osteoporosis Management Agent which can typically be delivered into human bodies by inges 0339. In certain embodiments, the functional ingredient is tion of the plants or the plant parts having the phytoestrogens. at least one osteoporosis management agent. Generally, As used herein, "phytoestrogen' refers to any Substance according to particular embodiments of this invention, the at which, when introduced into a body causes an estrogen-like least one osteoporosis management agent is present in the effect of any degree. For example, a phytoestrogen may bind Sweetened composition, i.e. a concentrate composition or to estrogen receptors within the body and have a small estro beverage, in an amount Sufficient to promote health and well gen-like effect. CSS. 0348 Examples of suitable phytoestrogens for embodi 0340 Osteoporosis is a skeletal disorder of compromised ments of this invention include, but are not limited to, isofla bone strength, resulting in an increased risk of bone fracture. Vones, stilbenes, lignans, resorcyclic acid lactones, Generally, osteoporosis is characterized by reduction of the coumeStans, coumestrol, equol, and combinations thereof. bone mineral density (BMD), disruption of bone micro-ar Sources of Suitable phytoestrogens include, but are not lim chitecture, and changes to the amount and variety of non ited to, whole grains, cereals, fibers, fruits, vegetables, black collagenous proteins in the bone. cohosh, agave root, black currant, black haw, chasteberries, 0341 In certain embodiments, the osteoporosis manage cramp bark, dong quai root, devil's club root, false unicorn ment agent is at least one calcium source. According to a root, ginseng root, groundsel herb, licorice, liferoot herb, US 2015/0018432 A1 Jan. 15, 2015

motherwortherb, peony root, raspberry leaves, rose family rily of 28 carbon 1-octanosol and 30 carbon 1-triacontanol, as plants, sage leaves, Sarsaparilla root, saw palmetto berried, well as other alcohols in lower concentrations such as 22 wild yam root, yarrow blossoms, legumes, soybeans, Soy carbon 1-docosanol, 24 carbon 1-tetracosanol, 26 carbon products (e.g., miso, soy flour, soymilk, Soy nuts, soy protein 1-hexacosanol, 27 carbon 1-heptacosanol. 29 carbon 1-nona isolate, tempen, or tofu) chick peas, nuts, lentils, seeds, clo cosanol, 32 carbon 1-dotriacontanol, and 34 carbon 1-tetra ver, red clover, dandelion leaves, dandelion roots, fenugreek contanol. seeds, green tea, hops, red wine, flaxseed, garlic, onions, 0357 Long-chain primary aliphatic saturated alcohols are linseed, borage, butterfly weed, caraway, chaste tree, Vitex, derived from natural fats and oils. They may be obtained from dates, dill, fennel seed, gotu kola, milk thistle, pennyroyal, these sources by using extraction techniques well known to pomegranates, Southernwood, soya flour, tansy, and root of those of ordinary skill in the art. Policosanols can be isolated the kudzu vine (pueraria root) and the like, and combinations from a variety of plants and materials including Sugar cane thereof. (Saccharum officinarium), yams (e.g. Dioscorea opposite), 0349 Isoflavones belong to the group of phytonutrients bran from rice (e.g. Oryza sativa), and beeswax. Policosanols called polyphenols. In general, polyphenols (also known as may be obtained from these sources by using extraction tech "polyphenolics’), are a group of chemical Substances found niques well known to those of ordinary skill in the art. A in plants, characterized by the presence of more than one description of such extraction techniques can be found in U.S. phenol group per molecule. Pat. Appl. No. 2005/0220868, the disclosure of which is 0350 Suitable phytoestrogen isoflavones in accordance expressly incorporated by reference. with embodiments of this invention include genistein, daid 0358 Phytosterols Zein, glycitein, biochanin A, formononetin, their respective 0359. In certain embodiments, the functional ingredient is naturally occurring glycosides and glycoside conjugates, at least one phytosterol, phytostanol or combination thereof. matairesinol, secoisolariciresinol, enterolactone, enterodiol. Generally, according to particular embodiments of this inven textured vegetable protein, and combinations thereof. tion, the at least one phytosterol, phytostanol or combination 0351 Suitable sources of isoflavones for embodiments of thereof is present in the Sweetened composition, e.g. concen this invention include, but are not limited to, soybeans, Soy trate composition or beverage, in an amount Sufficient to products, legumes, alfalfa spouts, chickpeas, peanuts, and red promote health and wellness. clover. 0360. As used herein, the phrases “stanol”, “plant stanol 0352 Long-Chain Primary Aliphatic Saturated Alcohol and “phytostanol are synonymous. 0353. In certain embodiments, the functional ingredient is 0361 Plant sterols and stanols are present naturally in at least one long chain primary aliphatic Saturated alcohol. Small quantities in many fruits, vegetables, nuts, seeds, cere Generally, according to particular embodiments of this inven als, legumes, vegetable oils, bark of the trees and other plant tion, the at least one long chain primary aliphatic Saturated Sources. Although people normally consume plant sterols and alcohol is present in the Sweetened composition, e.g. concen stanols every day, the amounts consumed are insufficient to trate composition or beverage, in an amount Sufficient to have significant cholesterol-lowering effects or other health promote health and wellness. benefits. Accordingly, it would be desirable to supplement 0354 Long-chain primary aliphatic saturated alcohols are food and beverages with plant sterols and Stanols. a diverse group of organic compounds. The term alcohol 0362 Sterols are a subgroup of steroids with a hydroxyl refers to the fact these compounds feature a hydroxyl group group at C-3. Generally, phytosterols have a double bond (—OH) bound to a carbon atom. The term primary refers to within the steroid nucleus, like cholesterol; however, phy the fact that in these compounds the carbon atom which is tosterols also may comprise a Substituted sidechain (R) at bound to the hydroxyl group is bound to only one other C-24. Such as an ethyl or methyl group, or an additional carbon atom. The term saturated refers to the fact that these double bond. The structures of phytosterols are well known to compounds feature no carbon to carbon pi bonds. The term those of skill in the art. aliphatic refers to the fact that the carbon atoms in these 0363 At least 44 naturally-occurring phytosterols have compounds are joined together in straight or branched chains been discovered, and generally are derived from plants. Such rather than in rings. The term long-chain refers to the fact that as corn, soy, wheat, and wood oils; however, they also may be the number of carbon atoms in these compounds is at least 8 produced synthetically to form compositions identical to carbons). those in nature or having properties similar to those of natu 0355 Non-limiting examples of particular long-chain pri rally-occurring phytosterols. According to particular embodi mary aliphatic Saturated alcohols for use in particular ments of this invention, non-limiting examples of phytoster embodiments of the invention include the 8 carbon atom ols well known to those or ordinary skill in the art include 1-octanol, the 9 carbon 1-nonanol, the 10 carbonatom 1-de 4-desmethylsterols (e.g., B-sitosterol, campesterol, Stigmas canol, the 12 carbon atom 1-dodecanol, the 14 carbon atom terol, brassicasterol, 22-dehydrobrassicasterol, and A5-ave 1-tetradecanol, the 16 carbon atom 1-hexadecanol, the 18 nasterol), 4-monomethyl sterols, and 4.4-dimethyl sterols carbon atom 1-octadecanol, the 20 carbon atom 1-eicosanol, (triterpene alcohols) (e.g., cycloartenol, 24-methylenecy the 22 carbon 1-docosanol, the 24 carbon 1-tetracosanol, the cloartanol, and cyclobranol). 26 carbon 1-hexacosanol, the 27 carbon 1-heptacosanol, the 0364. As used herein, the phrases “stanol”, “plant stanol 28 carbon 1-octanosol, the 29 carbon 1-nonacosanol, the 30 and phytostanol are synonymous. Phytostanols are satu carbon 1-triacontanol, the 32 carbon 1-dotriacontanol, and rated Sterol alcohols present in only trace amounts in nature the 34 carbon 1-tetracontanol. and also may be synthetically produced, such as by hydroge 0356. In a particularly desirable embodiment of the inven nation of phytosterols. According to particular embodiments tion, the long-chain primary aliphatic Saturated alcohols is of this invention, non-limiting examples of phytostanols policosanol. Policosanol is the term for a mixture of long include B-sitostanol, campestanol, cycloartanol, and Satu chain primary aliphatic Saturated alcohols composed prima rated forms of other triterpene alcohols. US 2015/0018432 A1 Jan. 15, 2015 26

0365 Both phytosterols and phytostanols, as used herein, beverage by an amount more than the detectable Sweetness of include the various isomers such as the C. and B isomers (e.g., a solution containing the same concentration of rebaudioside C-sitosterol and B-sitostanol, which comprise one of the most X and/or enhances the sweetness of the beverage by at least effective phytosterols and phytostanols, respectively, for low 1.0% Sucrose equivalence, Such as, for example from about ering serum cholesterol in mammals). 1.0% to about 3.0%. 0366. The phytosterols and phytostanols of the present 0370. In one embodiment, the rebaudiosideX has a purity invention also may be in their ester form. Suitable methods greater than 95%. for deriving the esters of phytosterols and phytostanols are 0371. In another embodiment, the sweetener is selected well known to those of ordinary skill in the art, and are from the group consisting of Sucrose, fructose, glucose, high disclosed in U.S. Pat. Nos. 6,589,588, 6,635,774, 6,800,317, fructose corn Syrup, high fructose starch syrup, D-psicose, and U.S. Patent Publication Number 2003/0045473, the dis D-allose, D-turanose, D-tagatose, D-trehalose, D-leucrose, closures of which are incorporated herein by reference in their rare Sugar syrup or a combination thereof. entirety. Non-limiting examples of Suitable phytosterol and 0372. In still another embodiment, rebaudioside X is phytostanol esters include sitosterol acetate, Sitosterol oleate, added in an amount to provide a final concentration of about Stigmasterol oleate, and their corresponding phytostanol 20 ppm to about 30 ppm in the beverage. esters. The phytosterols and phytostanols of the present 0373) In another embodiment, the present invention pro invention also may include their derivatives. vides a method for enhancing the Sweetness of a beverage comprising at least one Sweetener in a concentration above its III. METHODS Sweetness recognition threshold by adding a concentrate composition of the present invention, i.e. a concentrate com 0367. In one embodiment, the present invention provides a position comprising rebaudioside X having a purity greater method for enhancing the Sweetness of a Sweetened compo than about 95% and at least one Sweetener selected from the sition comprising at least one Sweetener in a concentration group consisting of Sucrose, fructose, glucose, high fructose above its Sweetness recognition threshold by adding rebau corn syrup, D-psicose, D-allose, D-turanose, D-tagatose, dioside Xin a concentration at or below its Sweetness recog D-trehalose, D-leucrose, rare Sugar syrup or a combination nition threshold. As stated previously, rebaudioside X thereof. enhances the Sweetness of the Sweetened composition by an amount more than the detectable Sweetness of a solution EXAMPLES containing the same concentration of rebaudioside X and/or enhances the Sweetness of the Sweetened composition by at Example 1 least about 1.0% (w/v) Sucrose equivalence, such as, for example from about 1.0% to about 3.0%. Evaluation of Rebaudioside X as a Sucrose Enhancer 0368. Any of the Sweetened compositions described in Beverages above can be used. 0374 Solutions were made by dissolving all ingredients in 0369. In a particular embodiment, a method for enhancing treated water. For citric acid buffer, citric acid and potassium the Sweetness of a beverage comprising at least one Sweetener citrate were added in a sufficient amount to bring the pH to in a concentration above its Sweetness recognition threshold 3.2. Finished products were filled in 300 ml-glass bottles and comprises adding rebaudioside X to said beverage in an stored in the refrigerator. Products were prepared with the amount at or below its Sweetness recognition threshold, ingredients provided in Tables 1-6. The RebaudiosideX used wherein the rebaudioside X enhances the Sweetness of the was 95% pure and obtained from Pure Circle. TABLE 1.

Sucrose solutions in water

O.S9/o 190 1.5% 79% 8% 9% 10% Ingredient (g) SUCOSE SUCOSE SUCOSE SCOS SCOSE SUCOSE SUCOS

Water 99.5 99 98.5 93 92 91 90 Sucrose O.S 1 1.5 7 8 9 10 TOTAL 100 g 100 g 100 g 100 g 100 g 100 g 100 g

TABLE 2

Sucrose in citric acid buffer solutions

O.S9/o 196 1.5% 79% 8% 9% 10% Ingredient (g) SUCOSE SCOSE SCOSE SCOSE SUCOSE SCOS SCOSE

Water 99.4 98.9 98.4 92.9 91.9 90.9 89.9 Citric Acid 0.075 0.075 0.075 0.075 0.075 0.075 0.075 Potassium Citrate O.O2S O.O2S O.O2S O.O2S O.O2S O.O2S O.O2S Sucrose O.S 1 1.5 7 8 9 10 TOTAL 100 g 100 g 100 g 100 g 100 g 100 g 100 g US 2015/0018432 A1 Jan. 15, 2015 27

TABLE 3 given mineral water for rinsing before tasting and between tasting different samples. Unsalted crackers were also given Rebaudioside X in water solutions to panelists to eat followed by rinsing their mouth with min 20 ppm 30 ppm eral water before tasting the next sample. Ingredient (g) RebX RebX 0376. The overall sweetness of the beverage containing 20 Water 1OO 100 ppm rebaudioside X in either water or citric acid buffer was RebX O.OO2 O.OO3 similar to the 1% sucrose beverage. Similarly, the overall sweetness of the beverage containing 30 ppm rebaudioside X TOTAL 100 g 100 g in either water or citric acid buffer was similar to the 1.5% Sucrose beverage. The overall Sweetness of the beverage con taining 7% sucrose and 20 ppm rebaudioside X in water or TABLE 4 citric acid buffer was similar to somewhere between the 9% and 10% sucrose beverage (a 9.5% sucrose average). The Rebaudioside X in citric acid buffer solutions overall Sweetness of the beverage containing 7% sucrose and 20 ppm 30 ppm 30 ppm rebaudioside X in either water or citric acid buffer Ingredient (g) RebX RebX was similar to the 10% sucrose beverage. 0377 The experiment clearly demonstrated that addition Water 99.9 99.9 of rebaudioside X in the amount at or below its Sweetness Citric Acid 0.075 0.075 Potassium Citrate O.O2S O.O2S recognition threshold (20 and 30 ppm) to a beverage contain RebX O.OO2 O.OO3 ing 7% Sucrose resulted in a Sweetness enhancement of about 1.5%. TOTAL 100 g 100 g Example 3 TABLE 5 Evaluation of Rebaudioside X as a High Fructose Rebaudioside X and 7% sucrose in water solutions Corn Syrup Enhancer in Beverages 7% sucrose + 20 ppm 7% sucrose + 30 ppm 0378 Lemon-lime carbonated soft drinks (CSD) were Ingredient (g) RebX RebX made by dissolving all ingredients in an amount of water sufficient to make a syrup from which finished beverages Water 93 93 were made by adding 5.5 parts carbonated water to 1 part Sucrose 7 7 syrup (beverage carbonation target of 3.7 volumes of CO). Products were prepared with the ingredients provided in TOTAL 100 g 100 g Table 8:

TABLE 8

TABLE 6 8% HFCS-SS - 8% 9% 10% Ingredients 30 ppm RebX HFCS-55 HFCS-55 HFCS-55 Rebaudioside X and 7% sucrose in citric acid buffer solutions (grams) (Experimental) Control Control Control 7% sucrose + 20 ppm 7% sucrose + 30 ppm Water 88.68 88.68 87.22 85.75 Ingredient (g) RebX RebX Citric Acid O.117 O.117 O.117 O.117 Sodium Citrate O.O27 O.O27 O.O27 O.O27 Water 92.9 92.9 Sodium Benzoate O.0185 O.O18S O.0185 O.O18S Citric Acid 0.075 0.075 Lemon Lime Flavor O.087 O.O87 O.087 O.O87 Potassium Citrate O.O2S O.O2S RebX O.OO3 Sucrose 7 7 HFCS-55 11.07 11.07 12.53 14 RebX O.OO2 O.OO3 TOTAL 100 g 100 g TOTAL 100 g 100 g 100 g 100 g Taste Evaluation: The beverages were aged for seven days at room temperature and then cooled at 4° C. before tasting. Taste Evaluation Four panelists evaluated the beverages. Bottles were removed 0375 Beverages were kept in the refrigerator overnight from the refrigerator and about 20 ml of beverage poured in 2 and tasted cold the following day. Two panelists evaluated the oZ-plastic cups. Mineral water was given for palate rinsing beverages. Bottles were removed from the refrigerator and before tasting and between tasting different samples. about 50 ml of the beverage was poured in 4 oz-plastic cups. 0379 The overall sweetness of the beverage containing Taste test were conducted in two sessions for each type of 8% HFCS-55 (same sweetness as 8% sucrose) and 30 ppm solution: water and citric acid buffer. In the first session, the rebaudioside X was similar to about 10% HFCS-55 (same sweetness level of the beverages containing 20 ppm and 30 sweetness as 10% sucrose) in lemon lime CSD. The experi ppm rebaudioside X were determined against the 0.5%, 1%, ment clearly demonstrated that addition of rebaudioside Xin and 1.5% Sucrose beverages. In the second session, the Sweet the amount at about its sweetness recognition threshold (30 ness level of the beverages containing 7% sucrose and either ppm) to a beverage containing 8% HFCS-55 (same sweetness 20 ppm or 30 ppm rebaudioside X were determined against as 8%. Sucrose) resulted in a Sweetness enhancement of about the 7%, 8%, 9%, and 10% sucrose beverages. Panelists were 2.0%. US 2015/0018432 A1 Jan. 15, 2015 28

1. A Sweetened composition comprising at least one Sweet 12. (canceled) ener and added rebaudioside X, 13. The sweetened composition of claim 1, wherein the wherein the at least one Sweetener is present in a concen rebaudioside X has a purity greater than about 95%. tration above its Sweetness recognition threshold, wherein rebaudioside X has a purity from about 80% to 14-37. (canceled) about 99% and is present in a concentration at or below 38. A beverage comprising at least one carbohydrate its Sweetness recognition threshold, and sweetener and added rebaudioside X, wherein wherein rebaudioside X enhances the Sweetness of the the at least one carbohydrate Sweetener is present in a Sweetened composition by an amount more than the concentration above its Sweetness recognition thresh detectable Sweetness of a solution containing the same old, concentration of rebaudiosideX in the absence of the at wherein rebaudioside X has a purity from about 80% to least one sweetener and/or the rebaudiosideX enhances about 99% and is present in a concentration at or below the sweetness of the Sweetened composition by at least its Sweetness recognition threshold, and about 1.0% sucrose equivalence wherein rebaudioside X enhances the sweetness of the 2. The Sweetened composition of claim 1, wherein the beverage by an amount more than the detectable Sweet rebaudioside X is present in a concentration from about 20 ness of a solution containing the same concentration of ppm to about 30 ppm. rebaudioside X in the absence of the at least one carbo 3. The Sweetened composition of claim 1, wherein the hydrate sweetener and/or the rebaudioside X enhances rebaudioside X enhances the Sweetness of the sweetened the sweetness of the beverage by at least about 1.0% composition by at least about 1.5% Sucrose equivalence. (w/v) Sucrose equivalence. 4. The Sweetened composition of claim 1, wherein the rebaudioside X enhances the Sweetness of the sweetened 39. The beverage of claim 38, wherein the rebaudioside X composition from about 1.0% to about 3.0% sucrose equiva is present in a concentration from about 5 ppm to about 30 lence. 5. The sweetened composition of claim 1, wherein the at 40. The beverage of claim 38, wherein rebaudioside X least one Sweetener is a carbohydrate Sweetener. enhances the sweetness of the beverage by at least about 1.5% 6. (canceled) (w/v) Sucrose equivalence. 7. The Sweetened composition of claim 5, wherein the 41. The beverage of claim 38, wherein rebaudioside X carbohydrate sweetener is selected from the group consisting enhances the Sweetness of the beverage from at least 1.0% to of Sucrose, fructose, glucose, high fructose corn syrup, high about 3.0% (w/v) sucrose equivalence. fructose starch syrup, erythritol, maltitol, lactitol, sorbitol, 42. (canceled) mannitol. Xylitol, tagatose, trehalose, rare Sugar syrup, galac 43. The beverage of claim 38, wherein the carbohydrate tose, rhamnose, cyclodextrin, ribulose, threose, arabinose, Sweetener is selected from the group consisting of Sucrose, Xylose, lyxose, allose, altrose, mannose, idose, lactose, mal fructose, glucose, high fructose corn syrup, high fructose tose, invert Sugar, isotrehalose, neotrehalose, palatinose, iso starch syrup, erythritol, maltitol, lactitol, Sorbitol, mannitol, maltulose, erythrose, deoxyribose, gulose, idose, talose, Xylitol, tagatose, trehalose, rare Sugar syrup, galactose, rham erythrulose, Xylulose, psicose, turanose, cellobiose, glu nose, cyclodextrin, ribulose, threose, arabinose, Xylose, lyX cosamine, mannosamine, fucose, fuculose, glucuronic acid, ose, allose, altrose, mannose, idose, lactose, maltose, invert gluconic acid, glucono-lactone, abequose, galactosamine, Sugar, isotrehalose, neotrehalose, palatinose, isomalitulose, Xylo-oligosaccharides, gentio-oligoscaccharides, galacto erythrose, deoxyribose, gulose, idose, talose, erythrulose, oligosaccharides, Sorbose, ketotriose, aldotriose, nigero-oli Xylulose, psicose, turanose, cellobiose, glucosamine, man gosaccharides, fructooligosaccharides, maltotetraose, mal nosamine, fucose, fuculose, glucuronic acid, gluconic acid, totriol, tetrasaccharides, mannan-oligosaccharides, malto glucono-lactone, abequose, galactosamine, Xylo-oligosac oligosaccharides, dextrins, lactulose, melibiose, raffinose, charides, gentio-oligoscaccharides, galacto-oligosaccha rhamnose, ribose, isomerized liquid Sugars, coupling Sugars, rides, Sorbose, ketotriose, aldotriose, nigero-oligosaccha Soybean oligosaccharides, glucose syrup and combinations rides, fructooligosaccharides, maltotetraose, maltotriol, thereof. tetrasaccharides, mannan-oligosaccharides, malto-oligosac 8. The Sweetened composition of claim 5, wherein the charides, dextrins, lactulose, melibiose, raffinose, rhamnose, carbohydrate Sweetener is selected from the group consisting ribose, isomerized liquid Sugars, coupling Sugars, soybean of Sucrose, fructose, glucose, high fructose corn syrup, high oligosaccharides, glucose syrup and combinations thereof. fructose starch syrup and combinations thereof. 9. The Sweetened composition of claim 5, wherein the 44. The beverage of claim 38, wherein the carbohydrate carbohydrate Sweetener is selected from the group consisting Sweetener is selected from the group consisting of Sucrose, of D-psicose, D-allose, D-turanose, D-tagatose, D-trehalose, fructose, glucose, high fructose corn syrup, high fructose D-leucrose, rare Sugar syrup and combinations thereof. starch syrup and combinations thereof. 10. The Sweetened composition of claim 1, wherein the 45. The beverage of claim 38, wherein the carbohydrate Sweetened composition is selected from the group consisting Sweetener is selected from the group consisting of D-psicose, of pharmaceutical compositions, edible gel mixes and com D-allose, D-turanose, D-tagatose, D-trehalose, D-leucrose, positions, dental compositions, foodstuffs, confections, con rare Sugar syrup and combinations thereof. diments, chewing gum, cereal compositions, baked goods, 46. The sweetened composition of claim 1, further com dairy products, tabletop Sweetener compositions, beverages prising one or more functional ingredient selected from the and beverage products. group consisting of antioxidants, dietary fiber Sources, fatty 11. The Sweetened composition of claim 10, wherein the acids, vitamins, glucosamine, minerals, preservatives, hydra composition is a beverage. tion agents, probiotics, prebiotics, weight management US 2015/0018432 A1 Jan. 15, 2015 29 agents, osteoporosis management agents, phytoestrogens, poly-amino acids and their corresponding salts, Sugar acids long chain primary aliphatic Saturated alcohols, phytosterols and their corresponding salts, nucleotides, organic acids, and combinations thereof. inorganic acids, organic salts including organic acid salts and 47. The sweetened composition of claim 1, further com organic base salts, inorganic salts, bitter compounds, fla prising one or more additives selected from the group con Vorants and flavoringingredients, astringent compounds, pro sisting of carbohydrates, polyols, amino acids and their cor teins or protein hydrolysates, emulsifiers, weighing agents, responding salts, poly-amino acids and their corresponding gums, antioxidants, colorants, flavonoids, alcohols, poly salts, Sugar acids and their corresponding salts, nucleotides, mers, essential oils, anti-fungal agents and combinations organic acids, inorganic acids, organic salts including organic thereof. acid salts and organic base salts, inorganic salts, bitter com 50. (canceled) pounds, flavorants and flavoring ingredients, astringent com pounds, proteins or protein hydrolysates, emulsifiers, weigh 51. The beverage of claim 38, wherein the rebaudioside X ing agents, gums, antioxidants, colorants, flavonoids, has a purity greater than about 95%. alcohols, polymers, essential oils, anti-fungal agents and 52. The beverage of claim 38, wherein the beverage is combinations thereof. selected from a cola, lemon-lime flavored sparkling beverage, 48. The beverage of claim 38, further comprising one or orange flavored sparkling beverage, grape flavored sparkling more functional ingredient selected from the group consisting beverage, Strawberry flavored sparkling beverage, pineapple of antioxidants, dietary fiber sources, fatty acids, Vitamins, flavored sparkling beverage, enhanced beverage with Vita glucosamine, minerals, preservatives, hydration agents, pro mins and/or minerals, ginger-ale, Soft drink, root beer, malt biotics, prebiotics, weight management agents, osteoporosis beverage, fruit juice, fruit-flavored juice, juice drink, nectar, management agents, phytoestrogens, long chain primary ali Vegetablejuice, vegetable-flavored juice, sports drink, energy phatic Saturated alcohols, phytosterols and combinations drink, protein drink, enhanced water with vitamin, near water thereof. drink, coconut water, tea, coffee, cocoa drink, beverage con 49. The beverage of claim 38, further comprising one or taining milk components, beverage containing cereal extracts more additives selected from the group consisting of carbo and Smoothie. hydrates, polyols, amino acids and their corresponding salts,