US010933074B2

( 12 ) United States Patent ( 10 ) Patent No .: US 10,933,074 B2 Williamson et al . (45 ) Date of Patent : Mar. 2 , 2021

( 54 ) METHODS FOR IMPROVING THE A23L 33/21 ( 2016.08 ) ; A23L 33/26 ( 2016.08 ) ; GASTROINTESTINAL TOLERANCE OF A61K 31/7016 ( 2013.01 ) ; A61K 31/716 FOOD AND BEVERAGE PRODUCTS ( 2013.01 ) ; A61K 31/721 ( 2013.01 ) ; A23V COMPRISING SWEET, LOW - DIGESTIBLE 2002/00 ( 2013.01 ) ; A23V 2200/32 ( 2013.01 ) CARBOHYDRATES ( 58 ) Field of Classification Search ( 71 ) Applicant: Tate & Lyle Ingredients Americas CPC A23L 33/10 ; A23L 33/17 ; A23L 27/38 ; LLC , Hoffman Estates , IL (US ) A23L 27/35 ; A23L 27/34 ; A23L 27/31 ; A23L 27/30 ; A23L 33/125 ; A23L 33/26 ; ( 72 ) Inventors: Patricia S. Williamson , Hoffman A23L 2/66 ; A23L 27/33 ; A23L 33/21 ; Estates, IL ( US ) ; Ryan D. Woodyer , A23L 2/52 , A23L 2/60 ; A61K 31/716 ; Hoffman Estates , IL (US ) A61K 31/721 ; A61K 31/7004 ; A61K 31/7016 ; A61K 2300/00 ; A23V 2002/00 ; ( 73 ) Assignee : Tate & Lyle Ingredients Americas A23V 2200/32 ; A23V 2250/384 ; A23V LLC , Hoffman Estates , IL (US ) 2250/5108 ; A23V 2250/5116 ; A23V 2250/54; A23V 2250/55 ; A23V 2250/61 ; ( * ) Notice : Subject to any disclaimer , the term of this A23V 2200/00 ; A23V 2250/00 , A23V patent is extended or adjusted under 35 2200/30 ; A23V 2250/602 ; A23V U.S.C. 154 ( b ) by 0 days. 2250/606 ; A23V 2250/612 ; A23V ( 21 ) Appl . No .: 15 / 762,304 2250/64 ; A23V 2250/6402 , A23V 2250/6401 ; A23V 2250/6412 , A23V ( 22 ) PCT Filed : Sep. 21 , 2016 2250/6416 ; A23V 2250/642 , A23V 2250/6422 ( 86 ) PCT No .: PCT / GB2016 / 052932 See application file for complete search history . $ 371 ( c ) ( 1 ) , ( 2 ) Date : Mar. 22 , 2018 ( 56 ) References Cited ( 87 ) PCT Pub . No .: W02017 / 051166 U.S. PATENT DOCUMENTS PCT Pub . Date : Mar. 30 , 2017 3,766,165 A * 10/1973 Rennhard A23C 9/1544 536 / 123.1 ( 65 ) Prior Publication Data 3,876,794 A * 4/1975 Rennhard A23G 1/56 US 2018/0264018 A1 Sep. 20 , 2018 426/548 ( Continued ) Related U.S. Application Data FOREIGN PATENT DOCUMENTS ( 60 ) Provisional application No. 62 / 222,478 , filed on Sep. CN 1510992 A 7/2004 23 , 2015 . CN 102475180 A 5/2012 ( 30 ) Foreign Application Priority Data (Continued ) Feb. 10 , 2016 (GB ) 1602410 OTHER PUBLICATIONS ( 51 ) Int . Ci . Grabitske et al ., “ Gastrointestinal Effects of Low - Digestible Car A61K 31/7004 ( 2006.01 ) bohydrates ” , Critical Reviews in Food Science and Nutrition , 2009 , A61K 31/716 ( 2006.01 ) vol . 49 , pp . 327-360 . A23L 2/60 ( 2006.01 ) ( Continued ) A23L 33/17 ( 2016.01 ) A23L 33/125 ( 2016.01 ) A23L 33/21 ( 2016.01 ) Primary Examiner Lawrence E Crane A61K 31/7016 ( 2006.01 ) ( 74 ) Attorney , Agent , or Firm - RatnerPrestia A23L 2730 ( 2016.01 ) A23L 2/52 ( 2006.01 ) A61K 31/721 ( 2006.01 ) ( 57 ) ABSTRACT ( Continued ) The present invention relates to methods for improving the ( 52 ) U.S. Cl . gastrointestinal tolerance of food and beverage products CPC A61K 31/7004 ( 2013.01 ) ; A23L 2/52 comprising sweet, low -digestible carbohydrates, and the use ( 2013.01 ) ; A23L 2/60 ( 2013.01 ) ; A23L 2766 of one or more of D - glucose , fiber and protein for improving ( 2013.01 ) ; A23L 27/30 ( 2016.08 ) ; A23L 27/31 the gastrointestinal tolerance of food and beverage products ( 2016.08 ) ; A23L 27/33 ( 2016.08 ) ; A23L 27/34 comprising sweet , low - digestible carbohydrates. ( 2016.08 ) ; A23L 27/35 ( 2016.08 ) ; A23L 27/38 ( 2016.08 ) ; A23L 33/10 ( 2016.08 ) ; A23L 33/125 ( 2016.08 ) ; A23L 33/17 ( 2016.08 ) ; 25 Claims , 6 Drawing Sheets US 10,933,074 B2 Page 2

( 51 ) Int . Ci. WO 2014175119 Al 10/2014 A23L 33/10 WO 2015075473 A 5/2015 ( 2016.01 ) WO 2015094342 A1 6/2015 A23L 33/26 ( 2016.01 ) A23L 2/66 ( 2006.01 ) OTHER PUBLICATIONS Hishiike et al ., “ Transepithelial Transports of Rare Sugar D - Psicose ( 56 ) References Cited in Human Intestine ”, Journal of Agricultural and Food Chemistry , 2013 , vol . 61 , pp . 7381-7386 . U.S. PATENT DOCUMENTS Iida et al ., “ Estimation of Maximum Non - effect Level of D - Psicose in Causing Diarrhea in Human Subjects ” with English Abstract, 4,042,714 A 8/1977 Torres A21D 2/18 Journal of Japanese Council for Advanced Food Ingredients Research , 426/62 2007 , vol . 10 , No. 1 , pp . 15-19 . 4,134,999 A 1/1979 Muhler et al . International Search Report and Written Opinion for International 4,304,768 A * 12/1981 Staub A23L 33/22 Application No. PCT / GB2016 / 052932 , dated Feb. 8 , 2017 , 30 426/558 pages . 4,379,782 A 4/1983 Staub et al . Knudsen , K.E. , “ Lactose in Diet Influences the Degradation of 4,962,094 A 10/1990 Jamas et al . Mixed Linked B ( 1-3 ; 1-4 )-D - glucan in the Small Intestine of Pigs ” , 5,028,437 A 7/1991 Jerrett J. Anim . Sci . 2012 , vol . 90 , pp . 125-127 . 6,399,142 B1 6/2002 Silver C08B 37/0054 Great Britain Combined Search Report and Examination for Appli 426/548 cation No. GB1602410.1 , dated Jul. 19 , 2016 , 7 pages . 7,147,883 B1 12/2006 Silver Third Party Observation for International Application No. PCT / 7,186,431 B1 * 3/2007 Silver A23L 29/244 GB2016 / 052932 , dated Jul. 20 , 2017 , 4 pages . 426/548 International Preliminary Report on Patentability for International 8,071,558 B2 12/2011 Tokuda et al. Application No. PCT / GB2016 / 052932 , dated Mar. 27 , 2018 , 23 8,735,108 B2 5/2014 Hong et al . pages . 9,049,876 B2 * 6/2015 Fujihara A23L 2/60 European Communication for European Application No. 16 775 9,109,266 B2 * 8/2015 Takamine A23L 2/60 821.8 , dated Jan. 10 , 2020 , 7 pages . 9,717,267 B2 * 8/2017 Prakash A23L 2/60 Kneepkens et al . , “ Incomplete Intestinal Absorption of Fructose ” , 2006/0051480 A1 3/2006 Miles Archives of Disease in Childhood , 1984 , vol . 59 , pp . 735-738 . 2006/0286248 Al 12/2006 Anfinsen et al . lida et al , “ Estimation of Maximum Non - Effect Level of D - Psicose 2010/0112174 Al 5/2010 Christensen et al . in Causing Diarrhea in Human Subjects ” with partial Journal of 2010/0130435 Al 5/2010 Tokuda et al. Japanese Council for Advanced Food Ingredients Research , 2007 , 2010/0204346 A1 8/2010 Okuma et al . vol . 10 , No. 1 , pp . 15-19 . 2011/0081476 A1 4/2011 Lee et al . English Translation of Japanese Office Action for Japanese Appli 2012/0070534 A1 3/2012 Suzuki cation No. 2018-534032 , dated Jun . 16 , 2020 , 8 pages . 2012/0076908 A1 3/2012 Fujihara et al . Chinese Office Action for Chinese Application No. 201680055582 . 2012/0094940 A1 4/2012 Takamine et al . 0 , dated Oct. 30 , 2020 with translation , 34 pages. 2013/0274350 A1 10/2013 Okuma et al . Beaugerie et al . , “ Sorbitol Absorption in the Healthy Human Small 2013/0323362 A1 12/2013 Penhasi Intestine is Increased by the Concomitant Ingestion of Glucose or 2014/0322389 Al 10/2014 Prakash et al . Lipids ” , Eur J Gastroenterol Hespatol ., 1995 , vol . 7 , No. 2 , pp . 2014/0342044 Al 11/2014 Bell et al . 125-128 ( abstract only) . 2015/0110940 A1 4/2015 Lee et al . Hoekstra et al. , “ Facilitating Effect of Amino Acids on Fructose and 2015/0216199 A1 8/2015 Porter et al . Sorbitol Absorption in Children ” , J Pediatr Gastroenterol Nutr ., 2016/0151305 A1 6/2016 Takako et al . 1996 , vol . 23 , No. 2 , pp . 118-124 ( Abstract only ) . Iga et al . , “ Effect of d - Allose on Glycemic Responses After Oral FOREIGN PATENT DOCUMENTS Carbohydrate Tolerance in Rats ” , Technical Bulletin of Faculty of CN 102919964 A 2/2013 Faculty of Agriculture - Kagawa University, 2009 ( 2 pgs . ) ( abstract CN 102972676 A 3/2013 only ) . JP 61500433 A 3/1986 Japanese Third Party Observations for Japanese Applications No. JP 2010018528 1/2010 2018-534032 , dated Oct. 14 , 2028 with translation , 8 pages . WO 2008082596 A2 7/2008 WO 2014007606 A1 1/2014 * cited by examiner U.S. Patent Mar. 2 , 2021 Sheet 1 of 6 US 10,933,074 B2

Visit 1 - Screening ( control beverage ) Sucrose control ( 25 g / serving) at breakfast and lunch ( must have GI symptom score < 3 to enter study) Subjects Randomized 6 control; 18 treatment

Each visit - control Visit 2 - treatment beverage 50g 30g allulosed sucrose / d Visit 3 - treatment 50g allulosed

Visit 4 - treatment 70g allulosed

Visit 5 - treatment 70g allulosed

Visit 6 - treatment 60g allulosed Fig . 1 U.S. Patent Mar. 2 , 2021 Sheet 2 of 6 US 10,933,074 B2

GI Symptom Frequency , # of scores 2 2 6 28 % 28 % 28 % N Abdominal 51 distension II Abdominal pains ,scores2Subjectreports24hrs Borborygmus 3 Increased flatus 2 Loose stools Nausea and vomiting 0 I 30g / d 50g / d 70g / d 70g / d - 2 60g/ d N = 18 Dosage Allulosed Fig . 2 U.S. Patent Mar. 2 , 2021 Sheet 3 of 6 US 10,933,074 B2

Visit 1 - Screening ( control beverage) Sucrose control ( 25 g / serving) at breakfast and lunch ( must have Gl symptom score of 0 to enter study) Subjects Randomized 2 control; 10 treatment

Visit 2 - control Visit 2 - treatment beverage 50g beverage 1 : 1 sucrose / d ( 50g allulose /d )

Visit 3 - treatment beverage 3 : 1 ( 50g allulose / d)

Visit 4 - treatment beverage 1 : 1 ( 70g allulose /d )

Visit 5 - treatment beverage 3 : 1 ( 70g allulose /d )

Visit 6 - treatment beverage 1 : 1 ( 90g allulose /d )

Visit 7 - treatment beverage 3 : 1 ( 90g allulose/ d ) Fig . 3 U.S. Patent Mar. 2 , 2021 Sheet 4 of 6 US 10,933,074 B2

Allulose:Gbeveragetolerance Allulose1:90g/d350g70g 4.Fig AbdominalpainHiNauseavomitingBorborygmusandN AbdominaldistensionGasStools

10 9 8 7 6 5 3 2 1 0 )scores severity 3 or 2 ( subject of Number U.S. Patent Mar. 2 , 2021 Sheet 5 of 6 US 10,933,074 B2

Bristol Stool Test score averages for the study of Example 3 . 7 6

5 4.2 3.7 4 4

3 2

Allulose to Beta - Glucan Allulose Only Sucrose Only Allulose Glucose Fig . 5 U.S. Patent Mar. 2 , 2021 Sheet 6 of 6 US 10,933,074 B2

1 Stools Gas Abdominaldistension Allulose+BetaGlucan AllReportsat24hr(Numberofsubjects>0) 6Fig. Alluloseonly Sucrose GlucoseNAllulose+ Borborygmus vomiting AbdominalpainNauseaand

10 CO 8 7 5 3 2 symptom any reporting subjects of Number US 10,933,074 B2 1 2 METHODS FOR IMPROVING THE and protein can improve the gastrointestinal tolerance of GASTROINTESTINAL TOLERANCE OF food and beverage products comprising a sweet, low -digest FOOD AND BEVERAGE PRODUCTS ible carbohydrate . COMPRISING SWEET, LOW - DIGESTIBLE CARBOHYDRATES 5 SUMMARY OF THE INVENTION The present invention relates to methods for improving CROSS - REFERENCE TO RELATED the gastrointestinal tolerance of food and beverage products APPLICATIONS comprising a sweet , low - digestible carbohydrate , and to the This is the national phase of International Application No. 10 use of one or more of D - glucose , fiber and protein in these PCT / GB2016 / 052932 , filed 21 Sep. 2016 , which claims methods . priority to United Kingdom Application No. 1602410.1 , According to an aspect of the present invention , there is filed 10 Feb. 2016 and U.S. Provisional Application No. provided a method for improving the gastrointestinal toler 62 / 222,478 , filed 23 Sep. 2015. The disclosure of each of ance of a food or beverage product comprising a sweet, these applications is incorporated herein by reference in its 15 low - digestible carbohydrate, wherein the method comprises entirety for all purposes . incorporating one or more of D - glucose , fiber and protein into the food or beverage product. FIELD OF THE INVENTION In some embodiments of the present invention, the fiber is dietary fiber . In certain embodiments of the present The present invention relates to methods for improving 20 invention, the fiber is one or more of beta - glucan and the gastrointestinal tolerance of food and beverage products polydextrose. comprising sweet , low - digestible carbohydrates, and the use In an embodiment, the method comprises incorporating of one or more of D - glucose , fiber and protein for improving D - glucose into the food or beverage product. In another the gastrointestinal tolerance of food and beverage products embodiment, the method comprises incorporating fiber into comprising sweet , low - digestible carbohydrates. 25 the food or beverage product. In a further embodiment, the method comprises incorporating protein into the food or BACKGROUND OF THE INVENTION beverage product. In an embodiment, the method comprises incorporating Public health agencies and expert scientific organizations beta -glucan into the food or beverage product. In an alter are encouraging the food industry to reduce calorie content 30 native embodiment, the method comprises incorporating and portion sizes in an effort to prevent and decrease obesity . polydextrose into the food or beverage product. In further Low- and no - calorie sweeteners that reduce calorie content embodiments, the method comprises incorporating beta in foods while meeting taste expectations are anticipated to glucan and polydextrose into the food or beverage product. help to meet these goals . In certain embodiments, the method comprises incorpo Displacement of calories with low and no - calorie sweet- 35 rating D - glucose and fiber into the food or beverage product. ener alternatives such as sweet , low - digestible carbohy- For example , the method comprises incorporating D - glucose drates is considered to help with weight maintenance and beta - glucan into the food or beverage product. In through reduced energy intake. However, one potential another example , the method comprises incorporating problem with the use of sugar substitutes and sweeteners is D - glucose and polydextrose into the food or beverage prod that some consumers can exhibit gastrointestinal sensitivi- 40 uct . In a further embodiment, the method comprises incor ties to the ingredients used to displace calories , such as the porating D - glucose , beta - glucan and polydextrose into the commonly used sweet , low - digestible carbohydrates eryth- food or beverage product. ritol , mannitol, and sorbitol (Grabitske , H. A .; Slavin , J. L .; In further embodiments , the method comprises incorpo Crit. Rev. Food . Sci . Nutr. , 2009 , 49 , 327-360 ) . rating D - glucose and protein into the food or beverage Absorption of carbohydrates from the intestinal tract is 45 product. In other further embodiments, the method com important to digestive comfort . Consumption of sugars , and prises incorporating fiber and protein into the food or sugar substitutes is often clinically evaluated to identify their beverage product. For example, the method comprises incor gastric tolerance limits . The gastrointestinal intolerances of porating protein and beta - glucan into the food or beverage dietary carbohydrates and sweeteners are noted by consum- product. In another example, the method comprises incor ers as the commonly experienced symptoms of gas , bloating , 50 porating protein and polydextrose into the food or beverage distension , and diarrhea . For example, in healthy adults, if product. In a further example, the method comprises incor more than 45 g of carbohydrates reaches the colon at any one porating protein , beta - glucan and polydextrose into the food time , it can cause osmotic diarrhea. Carbohydrate malab- or beverage product. sorption can thus produce an acceleration of colonic transit In another embodiment, the method comprises incorpo and fluid overload of the colon . 55 rating D - glucose , fiber and protein into the food or beverage Dietary increases in sweet , low - digestible carbohydrates product. For example , the method comprises incorporating ( e.g. sugar alcohols ) , which are less well absorbed , can lead D - glucose , beta - glucan and protein into the food or beverage to increased amounts of carbohydrate material going into the product. In another example, the method comprises incor colon . porating D - glucose , polydextrose and protein into the food In view of the above , there is a need for new ways to 60 or beverage product. In a further example , the method improve the gastrointestinal tolerance of food and beverage comprises incorporating D - glucose , beta - glucan , polydex products comprising carbohydrates , in particular, sweet , trose and protein into the food or beverage product. low - digestible carbohydrates, in high levels , so as to make The sweet , low - digestible carbohydrate may be selected it possible to have higher inclusion rates in foods without from the group consisting of lactose , sugar alcohols and rare resulting symptoms. 65 sugars . Preferred sweet , low - digestible carbohydrates It has surprisingly been found that D - glucose , fiber ( e.g. include sorbitol, maltitol , isomalt , isomaltulose , erythritol, dietary fiber ), in particular, beta - glucan and polydextrose , D - and L - xylitol, D- and L - allose , D - and L -tagatose , lactose , US 10,933,074 B2 3 4 melezitose , D- and L - arabinose , L - fructose, L - glucose and incorporating one or more of D - glucose , fiber and protein D- and L - allulose . Further preferred low - digestible carbo- into the food or beverage product. hydrates include D - sorbitol, lactose , erythritol, D - xylitol, According to another aspect of the present invention , D - tagatose , L - allulose , maltitol and isomaltulose. there is provided the use of a composition comprising one or In embodiments of the present invention wherein the 5 more of D - glucose , fiber and protein in a method for method comprises incorporating at least D - glucose into the improving the gastrointestinal tolerance of a food or bever food or beverage product, the sweet, low - digestible carbo- age product comprising a sweet , low - digestible carbohy hydrate is preferably present in the food or beverage product drate , wherein the method comprises incorporating one or in a weight ratio to D - glucose of from about 0.5 : 1 to about more of D - glucose , fiber and protein into the food or 10 : 1 , for example, in a weight ratio to D - glucose of from 10 beverage product. about 1 : 1 to about 5 : 1 or in a weight ratio to D - glucose of According to another aspect of the present invention , from about 1 : 1 to about 3 : 1 . More preferably, the sweet , there is provided the use of D - glucose for increasing the low - digestible carbohydrate is present in the food or bever- gastrointestinal tolerance of a food or beverage product age product in a weight ratio to D - glucose of about 1 : 1 . comprising a sweet , low - digestible carbohydrate . In embodiments of the present invention wherein the 15 According to another aspect of the present invention , method comprises incorporating at least beta - glucan into the there is provided the use of fiber for increasing the gastro food or beverage product, the beta - glucan is preferably intestinal tolerance of a food or beverage product compris present in an amount of about 0.5 g to about 6 g per labeled ing a sweet , low - digestible carbohydrate. serving of the food or beverage product. In an embodiment, there is provided the use of beta In other embodiments of the present invention wherein 20 glucan for increasing the gastrointestinal tolerance of a food the method comprises incorporating at least beta - glucan into or beverage product comprising a sweet, low - digestible the food or beverage product, the beta - glucan is present in carbohydrate . an amount of about 0.01 % by weight to about 20 % by In another embodiment, there is provided the use of weight with respect to the total weight of the food or polydextrose for increasing the gastrointestinal tolerance of beverage product. 25 a food or beverage product comprising a sweet , low -digest According to some embodiments of the invention , the ible carbohydrate . beta - glucan is oat beta - glucan . In a further embodiment, there is provided the use of a Preferably, the beta - glucan is present in the food or combination of polydextrose and beta - glucan for increasing beverage product in the form of a fraction rich in soluble the gastrointestinal tolerance of a food or beverage product dietary fibers containing at least about 20 % and up to about 30 comprising a sweet , low - digestible carbohydrate . 40 % beta - glucan ( on a dry weight basis ) of mean molecular According to another aspect of the present invention , weight of at least about 800 kDa . More preferably, the there is provided the use of protein for increasing the beta - glucan is in the form of a fraction rich in soluble dietary gastrointestinal tolerance of a food or beverage product fibers containing about 35 % beta - glucan ( on a dry weight comprising a sweet , low - digestible carbohydrate . basis ) of mean molecular weight of at least about 800 kDa. 35 According to another aspect , there is provided the use of In embodiments of the present invention wherein the a combination of D - glucose and fiber for increasing the method comprises incorporating at least polydextrose into gastrointestinal tolerance of a food or beverage product the food or beverage product, the polydextrose is present in comprising a sweet , low - digestible carbohydrate . an amount of about 0.1 g to about 40 g per labeled serving In an embodiment, there is provided the use of a combi of the food or beverage product. 40 nation of D - glucose and polydextrose for increasing the In other embodiments of the present invention wherein gastrointestinal tolerance of a food or beverage product the method comprises incorporating at least polydextrose comprising a sweet , low - digestible carbohydrate. into the food or beverage product, the polydextrose is In another embodiment, there is provided the use of a preferably present in an amount of about 0.1 % by weight to combination of D - glucose and beta - glucan for increasing the about 80 % by weight ( e.g. about 0.5 % by weight to about 45 gastrointestinal tolerance of a food or beverage product 50 % by weight) with respect to the total weight of the food comprising a sweet , low - digestible carbohydrate . or beverage product. In a further embodiment, there is provided the use of a In embodiments of the present invention wherein the combination of D - glucose , beta - glucan and polydextrose for method comprises incorporating at least protein into the increasing the gastrointestinal tolerance of a food or bever food or beverage product, the protein is present in an amount 50 age product comprising a sweet, low - digestible carbohy of about 0.1 to about 40 g per labeled serving of the food drate . or beverage product. According to another aspect , there is provided the use of In other embodiments of the present invention wherein a combination of D - glucose and protein for increasing the the method comprises incorporating at least protein into the gastrointestinal tolerance of a food or beverage product food or beverage product, the protein is present in an amount 55 comprising a sweet , low - digestible carbohydrate. of about 0.1 % by weight to about 80 % by weight with According to another aspect , there is provided the use of respect to the total weight of the food or beverage product. a combination of fiber and protein for increasing the gas According to some embodiments of the present invention , trointestinal tolerance of a food or beverage product com the sweet , low - digestible carbohydrate is present in the food prising a sweet, low - digestible carbohydrate. or beverage product in a total amount from about 1 g to 60 In an embodiment, there is provided the use of a combi about 100 g ( e.g. from about 1 g to about 25 g ) per labeled nation of protein and polydextrose for increasing the gas serving. trointestinal tolerance of a food or beverage product com According to another aspect of the present invention , prising a sweet, low - digestible carbohydrate . there is provided the use of one or more of D - glucose , fiber In another embodiment, there is provided the use of a and protein in a method for improving the gastrointestinal 65 combination of protein and beta - glucan for increasing the tolerance of a food or beverage product comprising a sweet , gastrointestinal tolerance of a food or beverage product low - digestible carbohydrate, wherein the method comprises comprising a sweet , low - digestible carbohydrate . US 10,933,074 B2 5 6 In a further embodiment, there is provided the use of a energy intake , but as these low and no - calorie ingredients combination of protein , beta -glucan and polydextrose for are used at increasing levels in the food supply there is increasing the gastrointestinal tolerance of a food or bever- concern about the gastrointestinal tolerance of the ingredi age product comprising a sweet, low - digestible carbohy- ents . Accordingly, the present invention is particularly con drate . 5 cerned with methods for improving the gastrointestinal According to another aspect , there is provided the use of tolerance of food and beverage products comprising sweet, a combination of D - glucose , fiber and protein for increasing low - digestible carbohydrates. the gastrointestinal tolerance of a food or beverage product The present invention is based on the surprising finding comprising a sweet, low - digestible carbohydrate . that one or more of D - glucose , fiber ( wherein the fiber is In an embodiment, there is provided the use of a combi 10 preferably one or more of beta -glucan and polydextrose ) and nation of D - glucose , polydextrose and protein for increasing protein can improve the gastrointestinal tolerance of food the gastrointestinal tolerance of a food or beverage product and beverage products comprising sweet , low - digestible comprising a sweet, low - digestible carbohydrate . carbohydrates . In another embodiment, there is provided the use of a According to an aspect of the present invention, there is increasingcombination the ofgastrointestinal D - glucose , betatolerance - glucan of anda food protein or bever- for 15 provided a method for improving the gastrointestinal toler age product comprising a sweet , low - digestible carbohy- ance of a food or beverage product comprising a sweet, drate . low - digestible carbohydrate, wherein the method comprises In a further embodiment, there is provided the use of a incorporating one or more of D - glucose , fiber (wherein the combination of D - glucose , beta - glucan , polydextrose and fiber is preferably one or more of beta - glucan and polydex protein for increasing the gastrointestinal tolerance of a food 20 trose ) and protein into the food or beverage product. or beverage product comprising a sweet , low - digestible In certain embodiments , the method comprises incorpo carbohydrate . rating only one of D - glucose , fiber and protein into the food According to a further aspect , there is provided one or or beverage product. For example, the method may comprise more of D - glucose , fiber and protein , or a composition incorporating D - glucose , fiber or protein into the food or comprising one or more of D - glucose, fiber and protein, for 25 beverage product. use in a method for improving the gastrointestinal tolerance In other embodiments, the method comprises incorporat of food and beverage products comprising a sweet, low digestible carbohydrate in accordance with earlier aspects of ing only one of D - glucose , beta - glucan and polydextrose the invention . into the food or beverage product. For example, the method According to another aspect of the present invention, may comprise incorporating D - glucose , beta - glucan or poly there is provided a food or beverage product comprising a 30 dextrose into the food or beverage product. sweet , low - digestible carbohydrate and one or more of In other embodiments, the method comprises incorporat D - glucose , fiber and protein , wherein the one or more of ing D - glucose and fiber into the food or beverage product. D - glucose , fiber and protein are present in an amount In further embodiments, the method comprises incorpo effective to improve the gastrointestinal tolerance of said rating any two of D - glucose , beta - glucan and polydextrose 35 into the food or beverage product. For example, the method food or beverage product. may comprise incorporating a combination of : D - glucose BRIEF DESCRIPTION OF THE DRAWINGS and beta - glucan ; D - glucose and polydextrose; or beta - glu can and polydextrose into the food or beverage product. FIG . 1 is a schematic of the treatment protocol used in In another embodiment, the method comprises incorpo Example 1 . 40 rating D - glucose , beta - glucan and polydextrose into the food FIG . 2 shows the results of the dose escalation study of or beverage product. In other words , the method may Example 1. Each bar on the chart corresponds to a specific comprise incorporating a combination of D - glucose , beta gastrointestinal symptom for a particular dosage . The height of the bars corresponds to the number of subjects who glucan and polydextrose into the food or beverage product. reported a subjective gastrointestinal symptom score of 2 or 45 ratingIn further D - glucose embodiments and protein, the intomethod the comprisesfood or beverageincorpo 3 at a given dose . product. In other further embodiments, the method com FIG . 3 is a schematic of the treatment protocol used in prises incorporating fiber and protein into the food or Example 2 . beverage product. For example, the method may comprise FIG . 4 shows the results of the tolerance study of Example incorporating protein and beta - glucan into the food or bev testinal2. Each symptombar on the for chart a particular corresponds dosage to a . Thespecific height gastroin of the 50 erage product. In another example, the method comprises bars corresponds to the number of subjects who reported a incorporating protein and polydextrose into the food or subjective gastrointestinal symptom score of 2 or 3 at a beverage product. In a further example, the method com given dose. prises incorporating protein , beta - glucan and polydextrose FIG . 5 shows the Bristol Stool Test score averages for the into the food or beverage product. study of Example 3. Each bar on the chart corresponds to the 55 In a further embodiment, the method comprises incorpo average Bristol Stool score in relation to each beverage rating D - glucose , fiber and protein into the food or beverage tested . The height of the bars corresponds to the average product. For example, the method may comprise incorpo score ( out of 7 ) . rating D - glucose , beta - glucan and protein into the food or FIG . 6 shows the results of the gastrointestinal ( GI ) beverage product. In another example, the method com tolerance study of Example 3. The height of the bars 60 prises incorporating D - glucose , polydextrose and protein corresponds to the number of subjects who reported any into the food or beverage product. In a further example, the symptom score at 24 hours post consumption . method comprises incorporating D - glucose , beta - glucan , polydextrose and protein into the food or beverage product. DETAILED DESCRIPTION Sweet, low -digestible carbohydrates are carbohydrates 65 that are sweet to taste , and when consumed at high levels Displacement of calories with low and no - calorie alter- ( e.g. more than 20-30 g / day ), have been known to cause natives could help with weight maintenance through reduced gastrointestinal responses such as abdominal distension , US 10,933,074 B2 7 8 abdominal pains , borborygmus, increased flatus, loose erance following ingestion of a food or beverage product stools , and nausea / vomiting when consumed as part of a comprising a sweet , low - digestible carbohydrate. The meth food or beverage product, particularly in sensitive individu- ods of the present invention may also improve the gastro als . Sweet , low - digestible carbohydrates include lactose , intestinal tolerance to the extent that there is an absence of sugar alcohols and rare sugars . 5 the symptoms of sweet , low - digestible carbohydrate con In the context of the present invention , the term “ sweet to sumption . taste ” means that the sweet, low - digestible carbohydrates According to certain embodiments of the present inven are at least 20 % as sweet as sucrose , but less than five times tion , the sweet , low - digestible carbohydrate is one or more as sweet as sucrose on an equal weight basis according to a selected from the group consisting of sorbitol, maltitol , paired comparison test . In order to determine that a low- 10 isomalt , isomaltulose, erythritol, xylitol , D- and L - allose , digestible carbohydrate has less than 5 times the sweetness D - and L - tagatose , lactose , melezitose , D- and L - arabinose , of sucrose, the assessment involves making solutions in L - fructose , L - glucose and D- and L - allulose . In preferred neutral pH water of sucrose at 15 % by weight and the test embodiments , the low - digestible carbohydrate is one or solution at 3 % by weight and performing sweetness paired more selected from the group consisting of D - sorbitol, comparison testing . If the test solution at 3 % by weight is 15 lactose , maltitol , erythritol, D - xylitol , D - tagatose , L - allu sweeter than sucrose at 15 % by weight then the test sweet- lose , maltitol and isomaltulose . ener is greater than 5 times the sweetness of sucrose . In order Food or beverage products which may be contemplated in to determine that a low - digestible carbohydrate has at least the context of the present invention include baked goods ; 20 % of the sweetness of sucrose , the assessment involves sweet bakery products ( including, but not limited to , rolls , making solutions in neutral pH water of test sweetener at 20 cakes, pies , pastries, and cookies ) ; pre - made sweet bakery 15 % by weight and the sucrose solution at 3 % by weight and mixes for preparing sweet bakery products; pie fillings and performing sweetness paired comparison . If the test solution other sweet fillings ( including , but not limited to , fruit pie at 15 % by weight is sweeter than sucrose at 3 % by weight fillings and nut pie fillings such as pecan pie filling, as well then the test sweetener is at least 20 % the sweetness of as fillings for cookies, cakes, pastries , confectionary prod sucrose . 25 ucts and the like , such as fat -based cream fillings) ; desserts, In the context of the present invention , the term “ fiber ” gelatins and puddings ; frozen desserts ( including, but not refers to one or more carbohydrates having a degree of limited to , frozen dairy desserts such as ice cream- -includ polymerization greater than 3 that resist digestion in the ing regular ice cream , soft serve ice cream and all other types intestine . In certain embodiments, the fiber is dietary fiber . of ice cream and frozen non -dairy desserts such as non Fibers which may be contemplated in the present invention 30 dairy ice cream , sorbet and the like ) ; carbonated beverages include cellulose , hemicellulose ( e.g. xylan , glucuronoxy- ( including , but not limited to , soft ( i.e. non - alcoholic ) car lan , arabinoxylan , glucomannan and xyloglucan ), inulin , bonated beverages ); non - carbonated beverages ( including , lignin , beta - glucan, pectin , polydextrose, psyllium , resistant but not limited to , soft non - carbonated beverages such as starch and wheat dextrin . In preferred embodiments , the flavored waters and sweet tea or coffee based beverages ); fiber is one or more of beta - glucan and polydextrose . 35 beverage concentrates ( including, but not limited to , liquid Sugar alcohols are also known as polyols . Examples of concentrates and syrups as well as non - liquid concentrates ”, sugar alcohols include sorbitol, maltitol , isomalt , erythritol, such as freeze - dried and / or powder preparations ); yogurts xylitol , lactitol , and mannitol. Sugar alcohols are generally ( including , but not limited to , full fat, reduced fat and able to provide a degree of calorie reduction ( by way of fat - free dairy yogurts, as well non -dairy and lactose - free example, sorbitol provides about 2.6 kcal/ g compared to 40 yogurts and frozen equivalents of all of these ) ; snack bars about 4 kcal / g for sucrose ). However, these sweeteners are ( including , but not limited to , cereal, nut, seed and / or fruit often not suitable for use at high levels due to low gastro- bars ); bread products ( including , but not limited to , leavened intestinal tolerance . and unleavened breads , yeasted and unyeasted breads such Rare sugars are monosaccharides which occur in very as soda breads , breads comprising any type of wheat flour, small quantities in nature . They include , but are not limited 45 breads comprising any type of non -wheat flour ( such as to L - sugars, D - allose , D - allulose , D - tagatose , D -turanose , potato , rice and rye flours ), gluten - free breads ) ; pre -made D - leucrose , lactulose , trehalose and isomaltulose . Excessive bread mixes for preparing bread products; sauces , syrups consumption of rare sugars can lead to gastrointestinal and dressings ; sweet spreads ( including, but not limited to , issues . jellies , jams , butters, nut spreads and other spreadable pre Certain individuals lack the ability to digest lactose as a 50 serves, conserves and the like ) ; confectionary products ( in result of having insufficient levels of lactase , which is an cluding, but not limited to , jelly candies , soft candies , hard enzyme that catalyzes the hydrolysis of lactose into glucose candies, chocolates and gums ) ; sweetened breakfast cereals and galactose . If undigested, lactose will travel into the gut ( including , but not limited to , extruded ( kix type ) breakfast where it acts as food for gas -producing gut flora . Therefore , cereals, flaked breakfast cereals and puffed breakfast cere consumption of lactose by intolerant individuals, or exces- 55 als ) ; and cereal coating compositions for use in preparing sive consusumption of lactose by individuals that are able to sweetened breakfast cereals. Other types of food or beverage produce normal levels of lactase , can cause gastrointestinal product not mentioned here but which conventionally issues . include one or more low- or non - digestible carbohydrate Symptoms associated with the gastrointestinal intolerance may also be contemplated in the context of the present of sugar alcohols , rare sugars and lactose include , but are not 60 invention . limited to , abdominal distension , abdominal pains , borbo- The sweet , low - digestible carbohydrate in the food or rygmus, increased flatus, loose stools , and nausea / vomiting . beverage products may be present in an amount of up to Accordingly, in the context of the present invention, improv- about 80 % by weight relative to the total weight of the food ing the gastrointestinal tolerance of a food or beverage or beverage product, for example, in an amount of from product comprising a sweet, low - digestible carbohydrate 65 about 1 % by weight to about 80 % by weight relative to the involves reducing the occurrence and severity of the some or total weight of the food or beverage product. All interme all of the symptoms associated with gastrointestinal intol- diate amounts ( i.e. 2 % , 3 % , 4 % ... 77 % , 78 % , 79 % by US 10,933,074 B2 9 10 weight relative to the total weight of the food or beverage bohydrate. However, in other embodiments, it may be product) are contemplated , as are all intermediate ranges desirable to include another sweetener or sweeteners . Thus, based on these amounts . the food or beverage product may contain one or more According to certain embodiments of the present inven- natural or artificial co - sweetener. tion , the sweet, low - digestible carbohydrate is present in the 5 Various natural high intensity sweeteners may be used as food or beverage product in an amount from about 1 g to the one or more co - sweetener . Specific examples include about 100 g per labeled serving ( or portion ) of the food or monk fruit extracts and stevia extracts, as well as any sweet beverage product. All intermediate amounts ( i.e. 2 g , 3 g 4 compounds isolated from such extracts ( including synthetic g .. 97 g , 98 g , 99 g ) are contemplated , as are all equivalents of such compounds ). intermediate ranges based on these amounts . For example, 10 Monk fruit is the fruit of the siraitia grosvenorii vine , also the low - digestible carbohydrate may be present in an known as luo han guo . The sweet taste of monk fruit extracts amount from about 5 g to about 90 g , about 5 g to about 80 is mainly attributed to a family of compounds known as g , about 10 g to about 80 g , about 10 g to about 70 g , about ‘mogrosides ', examples of which include mogroside V , 15 g to about 70 g , about 15 g to about 60 g , or about 15 g mogroside IV , mogroside VI , oxomogroside V , mogroside to about 50 g per labeled serving of the food or beverage 15 IIIE , neomogroside and siamenoside I. Monk fruit extracts , product . as well as sweeteners comprising any one or more mogro The labeled serving refers to the manufacturer's sug- side , may be used as the one or more co - sweetener. Extracts gested portion size of a particular food or beverage that an or sweeteners comprising mogroside V are particularly individual should consume in any one sitting . The suggested preferred . portion size will vary depending on the type of food or 20 Stevia , or Stevia rebaudiana , contains sweet compounds beverage product. For example , a food product may have a in its leaves . These compounds may be extracted to provide suggested portion size of between about 10 g to about 300 stevia extracts . The sweet taste of stevia extracts is mainly g , whereas a beverage product may have a suggested portion attributed to a family of compounds known as “ steviol size of between about 25 ml to about 500 ml . Accordingly , glycosides ' , examples of which include rebaudiosides ( i.e. , the labeled serving for a food product may be between about 25 rebaudioside A to F , M , N and X ) , rubusoside , stevioside , 10 g to about 300 g and the labeled serving for a beverage and dulcosides . Stevia extracts , as well as sweeteners com product may be between about 25 ml to about 500 ml . prising any one or more steviol glycoside, may be used as When the food or beverage product is a carbonated the one or more co - sweetener . Extracts or sweeteners com beverage, the carbonated beverage may comprise the sweet , prising rebaudioside A ( Reb A ) are particularly preferred . low digestible carbohydrate in an amount of from about 2 % 30 Blends or mixtures of individual steviol glycosides which by weight to about 25 % by weight relative to the total weight have been individually isolated , produced and / or purified of the carbonated beverage, for example in an amount of may also be used to advantage. from about 2 % by weight to about 20 % by weight relative The stevia extract for use as the one or more co - sweetener to the total weight of the carbonated beverage, for example preferably comprises steviol glycosides in a total amount of in an amount of from about 2 % by weight to about 15 % by 35 at least 90 weight % , preferably in a total amount of 95 weight relative to the total weight of the carbonated bever- weight % or more , relative to the total weight of the stevia age , for example in an amount of from about 2 % by weight extract on a dry solids basis . For example, the stevia extract to about 7 % by weight relative to the total weight of the may comprise steviol glycosides in a total amount of at least carbonated beverage , for example in an amount of from 90 , 91 , 92 , 93 , 94 , 95 , 96 , 97 , 98 or 99 weight % , relative to about 4 % by weight to about 6 % by weight relative to the 40 the total weight of the stevia extract on a dry solids basis . total weight of the carbonated beverage , for example in an A preferred stevia extract for use as the one or more amount of about 2 % , 2.2 % , 3 % , 4 % , 4.5 % , 5 % , 5.5 % , 6 % , co - sweetener comprises Rebaudioside A and Stevioside in a 6.5 % , 7 % , 8 % , 9 % , 10 % , 15 % , 20 % or 25 % by weight combined total amount of at least 70 weight % , preferably relative to the total weight of the carbonated beverage . in a combined total amount of 75 weight % or more , relative When the food or beverage product is a non - carbonated 45 to the total weight of the stevia extract on a dry solids basis . beverage, the non - carbonated beverage may comprise the Another preferred stevia extract for use as the one or more sweet , low digestible carbohydrate in an amount of from co - sweetener comprises Rebaudioside B in an amount of about 1 % by weight to about 25 % by weight relative to the from about 15 weight % to about 30 weight % , preferably total weight of the non - carbonated beverage, for example in from about 19 weight % to about 23 weight % , relative to the an amount of from about 2 % by weight to about 20 % by 50 combined total weight of steviol glycosides in the stevia weight relative to the total weight of the non - carbonated extract on a dry solids basis . beverage, for example in an amount of from about 2 % by One circumstance where it may be desirable or necessary weight to about 15 % by weight relative to the total weight to include one or more co - sweetener is where regulatory of the non - carbonated beverage, for example in an amount restrictions prescribe a maximum amount of the sweet, of from about 2 % by weight to about 7 % by weight relative 55 low - digestible carbohydrate to be used in a particular type of to the total weight of the non - carbonated beverage, for food or beverage product. An example of such regulatory example in an amount of from about 4 % by weight to about restrictions is the GRAS (Generally Recognized as Safe ) 6 % by weight relative to the total weight of the non- regime prescribed by the Food and Drug Administration carbonated beverage, for example in an amount of about 1 % , ( FDA ) in the United States . Where regulatory restrictions of 1.5 % , 2 % , 2.5 % , 3 % , 3.5 % , 4 % , 4.5 % , 5 % , 5.5 % 6 % , 6.5 % , 60 this type apply , the sweet, low - digestible carbohydrate may 7 % , 8 % , 9 % , 10 % , 15 % , 20 % or 25 % by weight relative to be used up to its maximum allowable usage amount, and one the total weight of the non - carbonated beverage . or more co - sweetener may be used to provide any additional In certain embodiments , the food or beverage product sweetness required . does not contain any other sweeteners other than the sweet , One aspect of the present invention relates to the unex low digestible carbohydrate and the D - glucose ( if present) 65 pected finding that D - glucose can improve the gastrointes used to improve the gastrointestinal tolerance of the food or tinal tolerance of a food or beverage product comprising a beverage product comprising the sweet , low digestible car- sweet , low - digestible carbohydrate . Specifically, this aspect US 10,933,074 B2 11 12 provides a method for improving the gastrointestinal toler- an amount of about 35 g per labeled serving, and D - glucose ance of a food or beverage product comprising a sweet, in an amount of about 35 g per labeled serving. In another low - digestible carbohydrate , wherein the method comprises embodiment, the food or beverage comprises D - allulose in incorporating D - glucose into the food or beverage product. an amount of about 45 g per labeled serving, and D - glucose In embodiments of the present invention wherein the 5 in an amount of about 45 g per labeled serving. method comprises incorporating only D - glucose into the Another aspect of the present invention relates to the food or beverage product ( i.e. fiber and protein are not unexpected finding that fiber ( in particular, beta - glucan and incorporated into the food or beverage product) the at least one carbohydrate is preferably selected from the group polydextrose ) can improve the gastrointestinal tolerance of consisting of D - and L - tagatose , erythritol, D- and L - allu- 10 a food or beverage product comprising a sweet , low -digest lose . ible carbohydrate. In embodiments of the present invention wherein the In embodiments of the present invention wherein the method comprises incorporating D - glucose into the food or method comprises incorporating fiber into the food or bev beverage product, the sweet, low - digestible carbohydrate erage product, the fiber is preferably present in an amount of may be present in the food or beverage product in a weight 15 about 0.1 g to about 50 g per labeled serving of the food or ratio to D - glucose of from about 0.5 : 1 to about 10 : 1 ( for beverage product. All intermediate amounts ( i.e. 1 g , 2 g , 3 example , about 0.5 : 1 , 0.6 : 1 , 0.7 : 1 , 0.8 : 1 , 0.9 : 1 , 1 : 1 , 1.1 : 1 , g ... 47 g , 48 g , 49 g per labeled serving ) are contemplated, 1.2 : 1 , 1.3 : 1 , 1.4 : 1 , 1.5 : 1 , 1.6 : 1 , 1.7 : 1 , 1.8 : 1 , 1.9 : 1 , 2 : 1 , 2.1 : 1 , as are all intermediate ranges based on these amounts . 2.2 : 1 , 2.3 : 1 , 2.4 : 1 , 2.5 : 1 , 2.6 : 1 , 2.7 : 1 , 2.8 : 1 , 2.9 : 1 , 3 : 1 , 3.1 : 1 , In other embodiments of the present invention wherein 3.2 : 1 , 3.3 : 1 , 3.4 : 1,3.5 : 1 , 3.6 : 1 , 3.7 : 1 , 3.8 : 1 , 3.9 : 1 , 4 : 1 , 4.1 : 1 , 20 the method comprises incorporating at least fiber into the 4.2 : 1 , 4.3 : 1 , 4.4 : 1 , 4.5 : 1 , 4.6 : 1 , 4.7 : 1 , 4.8 : 1 , 4.9 : 1 , 5 : 1 , 5.1 : 1 , food or beverage product, the fiber is present in an amount 5.2 : 1 , 5.3 : 1 , 5.4 : 1 , 5.5 : 1 , 5.6 : 1 , 5.7 : 1 , 5.8 : 1,5.9 : 1 , 6 : 1 , 6.1 : 1 , of about 0.1 % by weight to about 80 % by weight with 6.2 : 1 , 6.3 : 1 , 6.4 : 1 , 6.5 : 1 , 6.6 : 1 , 6.7 : 1 , 6.8 : 1 , 6.9 : 1 , 7 : 1 , 7.1 : 1 , respect to the total weight of the food or beverage product. 7.2 : 1 , 7.3 : 1 , 7.4 : 1 , 7.5 : 1 , 7.6 : 1 , 7.7 : 1 , 7.8 : 1 , 7.9 : 1 , 8 : 1 , 8.1 : 1 , All intermediate amounts ( i.e. 1 % , 2 % , 3 % ... 77 % , 78 % , 8.2 : 1 , 8.3 : 1 , 8.4 : 1 , 8.5 : 1 , 8.6 : 1 , 8.7 : 1 , 8.8 : 1 , 8.9 : 1 , 9 : 1 , 9.1 : 1 , 25 79 % by weight relative to the total weight of the food or 9.2 : 1 , 9.3 : 1 , 9.4 : 1 , 9.5 : 1 , 9.6 : 1 , 9.7 : 1 , 9.8 : 1,9.9 : 1 and 10 : 1 ) . beverage product) are contemplated , as are all intermediate In an embodiment, the sweet, low - digestible carbohydrate is ranges based on these amounts . present in the food or beverage product in a weight ratio to When the method comprises incorporating at least fiber D - glucose of from about 1 : 1 to about 5 : 1 . Preferably, the into the food or beverage product, the sweet, low -digestible sweet , low - digestible carbohydrate is present in the food or 30 carbohydrate may be present in the food or beverage product beverage product in a weight ratio to D - glucose of from in a weight ratio to fiber of from about 100 : 1 to about 5 : 1 about 1 : 1 to about 4 : 1 , more preferably in a weight ratio to ( for example , about 95 : 1 , 90 : 1 , 85 : 1 , 80 : 1 , 75 : 1 , 70 : 1 , 65 : 1 , D - glucose of from about 1 : 1 to about 3 : 1 . Even more 60 : 1 , 55 : 1 , 50 : 1 , 45 : 1 , 40 : 1 , 35 : 1 , 30 : 1 , 25 : 1 , 20 : 1 , 15 : 1 , preferably, the sweet, low - digestible carbohydrate is present 10 : 1 and 5 : 1 ) . In an embodiment, the sweet , low - digestible in the food or beverage product in a weight ratio to D - glu- 35 carbohydrate is present in the food or beverage product in a cose of about 1 : 1 . weight ratio to fiber of from about 50 : 1 to about 5 : 1 . In certain embodiments of the present invention , the Preferably, the sweet , low - digestible carbohydrate is present sweet , low - digestible carbohydrate is D - allulose and the in the food or beverage product in a weight ratio to fiber of method comprises incorporating D - glucose into the food or from about 50 : 1 to about 10 : 1 , more preferably in a weight beverage product , wherein the D - allulose is present in the 40 ratio to fiber of from about 40 : 1 to about 10 : 1 . Even more food or beverage product in a weight ratio to D - glucose of preferably, the sweet, low - digestible carbohydrate is present from about 1 : 1 to about 4 : 1 . Preferably, the D - allulose is in the food or beverage product in a weight ratio to fiber of present in a weight ratio to D - glucose of from about 1 : 1 to from about 30 : 1 to about 20 : 1 ( e.g. 25 : 1 ) . about 3 : 1 . In a more preferred embodiment, the D - allulose In certain embodiments, the food or beverage comprises is present in a weight ratio to D - glucose of about 1 : 1 . 45 D - allulose in an amount between about 10 g and about 50 g The food or beverage product may comprise the sweet , per labeled serving, and fiber in an amount between about low - digestible carbohydrate in an amount between about 10 0.5 g and about 6.0 g per labeled serving. In an embodiment, g and about 50 g per labeled serving, and D - glucose in an the food or beverage comprises D - allulose in an amount amount between about 10 g and about 50 g per labeled between about 10 g and about 40 g per labeled serving, and serving. All intermediate amounts ( i.e. 11 g , 12 g , 13 g ... 50 fiber in an amount between about 0.5 g and about 4.0 g per 47 g , 48 g , 49 g per labeled serving ) are contemplated , as are labeled serving. In another embodiment, the food or bever all intermediate ranges based on these amounts . In certain age comprises D - allulose in an amount between about 20 g embodiments, the food or beverage product comprises the and about 40 g per labeled serving, and fiber in an amount sweet , low - digestible carbohydrate in an amount between between about 0.5 g and about 2.0 g per labeled serving. In about 20 g and about 50 g per labeled serving ( for example , 55 another embodiment, the food or beverage comprises D -al about 25 g , 35 g , or 45 g per labeled serving) and D - glucose lulose in an amount between about 20 g and about 30 g per in an amount between about 20 g and about 50 g per labeled labeled serving, and fiber in an amount between about 0.5 g serving ( for example, about 25 g , 35 g , or 45 g per labeled and about 1.5 g per labeled serving. In another embodiment, serving ). the food or beverage comprises D - allulose in an amount of In certain embodiments, the food or beverage comprises 60 about 25 g per labeled serving, and fiber in an amount of D - allulose in an amount between about 20 g and about 50 g about 1.0 g per labeled serving . per labeled serving, and D - glucose in an amount between In a preferred embodiment of this aspect , there is provided about 20 g and about 50 g per labeled serving. In an a method for improving the gastrointestinal tolerance of a embodiment, the food or beverage comprises D - allulose in food or beverage product comprising a sweet, low - digestible an amount of about 25 g per labeled serving , and D - glucose 65 carbohydrate, wherein the method comprises incorporating in an amount of about 25 g per labeled serving. In another beta - glucan into the food or beverage product. In other embodiment, the food or beverage comprises D - allulose in words, the fiber is beta - glucan. US 10,933,074 B2 13 14 Beta - glucans are soluble dietary fibers from oat and between about 0.1 % by weight to about 3 % by weight, or barley grains . Beta - glucans can be obtained from other between about 0.1 % by weight to about 2 % by weight ). natural sources such as yeast and mushrooms. In structural Further, when the method comprises incorporating beta terms , beta - glucans are mixed - linkage ( 1-3 ) , ( 1-4 ) B - D- glucan into the food or beverage product, the sweet , low glucose polymers . The mean molecular weight of beta- 5 digestible carbohydrate may be present in the food or glucan has been reported to vary between 50 and 3000 kDa. beverage product in a weight ratio to beta - glucan of from In the present invention , the mean molecular weight of the about 100 : 1 to about 5 : 1 ( for example, about 95 : 1 , 90 : 1 , beta - glucan is between about 1 and about 10000 kDa . 85 : 1 , 80 : 1 , 75 : 1 , 70 : 1 , 65 : 1 , 60 : 1 , 55 : 1 , 50 : 1 , 45 : 1 , 40 : 1 , Preferably, the mean molecular weight of the beta - glucan is 35 : 1 , 30 : 1 , 25 : 1 , 20 : 1 , 15 : 1 , 10 : 1 and 5 : 1 ) . In an embodi between about 100 and about 1000 kDa 10 ment, the sweet , low - digestible carbohydrate is present in In preferred embodiments of the present invention , the the food or beverage product in a weight ratio to beta - glucan beta - glucan is oat beta - glucan . of from about 50 : 1 to about 5 : 1 . Preferably, the sweet, In other preferred embodiments , the beta -glucan is pres- low - digestible carbohydrate is present in the food or bever ent in the food or beverage product in the form of a fraction 15 age product in a weight ratio to beta - glucan of from about rich in soluble dietary fibers containing at least about 20 % 50 : 1 to about 10 : 1 , more preferably in a weight ratio to and up to about 40 % beta - glucan ( on a dry weight basis ) of beta - glucan of from about 40 : 1 to about 10 : 1 . Even more mean molecular weight of at least about 800 kDa . More preferably, the sweet, low - digestible carbohydrate is present preferably, the beta - glucan is present in the food or beverage in the food or beverage product in a weight ratio to beta product in the form of a fraction rich in soluble dietary fibers 20 glucan of from about 30 : 1 to about 20 : 1 ( e.g. 25 : 1 ) . containing about 35 % beta - glucan ( on a dry weight basis ) of In certain embodiments, the food or beverage comprises mean molecular weight of at least about 800 kDa D - allulose in an amount between about 10 g and about 50 g Beta - glucans are capable of making viscous , shear thin- per labeled serving, and beta - glucan in an amount between ning solutions , even at low concentrations. The viscosity of about 0.5 g and about 6.0 g per labeled serving. In an beta - glucans is dependent on their concentration in aqueous 25 embodiment, the food or beverage comprises D - allulose in solution . In the present invention , the beta - glucan may have an amount between about 10 g and about 40 g per labeled low , medium or high viscosity . For example, the beta - glucan serving, and beta - glucan in an amount between about 0.5 g may be beta - glucan that has a specific viscosity in the and about 4.0 g per labeled serving. In another embodiment, range of about 1 cSt to about 20 cSt when at a concentration the food or beverage comprises D - allulose in an amount of 0.5 % by weight in water ( relative to the total weight of the 30 between about 20 g and about 40 g per labeled serving, and aqueous solution ). Alternatively, the beta - glucan may have a beta - glucan in an amount between about 0.5 g and about 2.0 specific viscosity in the range of about 20 cSt to about 50 cSt g per labeled serving. In another embodiment, the food or when at a concentration of 0.5 % by weight ( e.g. about 20 cSt beverage comprises D - allulose in an amount between about to about 30 cSt when at a concentration of 0.5 % by weight ). 20 g and about 30 g per labeled serving, and beta - glucan in In other embodiments , the beta - glucan may have a specific 35 an amount between about 0.5 g and about 1.5 g per labeled viscosity that is greater than about 50 cSt when at a serving. In another embodiment, the food or beverage com concentration of 0.5 % by weight ( e.g. greater than about 100 prises D - allulose in an amount of about 25 g per labeled cSt when at a concentration of 0.5 % by weight ). serving, and beta - glucan in an amount of about 1.0 g per In embodiments of the present invention wherein the labeled serving method comprises incorporating beta - glucan into the food or 40 In embodiments of the present invention wherein the beverage product, the beta - glucan is preferably present in an method comprises incorporating only beta - glucan into the amount between about 0.5 g and about 6 g ( for example , food or beverage product ( i.e. D - glucose , other fibers and about 1 g . 2 g , 3 g , 4 g 5 g , or 6 g ) per labeled serving of protein are not incorporated into the food or beverage the food or beverage product. In embodiments of the inven- product) the sweet, low - digestible carbohydrate is one or tion where the beta - glucan is in the form of a fraction rich 45 more selected from the group consisting of sorbitol, maltitol , in soluble dietary fibers containing about 35 % beta - glucan isomalt , isomaltulose, erythritol, xylitol , D- and L - allose , ( on a dry weight basis ) of mean molecular weight of at least D - and L -tagatose , lactose , melezitose , D- and L - arabinose , about 800 kDa , the beta - glucan is preferably present in an L - fructose , L - glucose and D- and L - allulose . amount of about 1.5 g per labeled serving of the food or In another preferred embodiment of this aspect , there is beverage product. 50 provided a method for increasing the gastrointestinal toler Alternatively, the beta - glucan is incorporated in the food ance of a food or beverage product comprising a sweet, or beverage product in an amount of between about 0.01 % low -digestible carbohydrate, wherein the method comprises by weight to about 20 % by weight with respect to the total incorporating polydextrose into the food or beverage prod weight of the food or beverage product. All intermediate uct . In other words , the fiber is polydextrose. amounts ( i.e. 1 % , 2 % , 3 % ... 17 % , 18 % , 19 % by weight 55 Polydextrose is a synthetic polymer of glucose . More relative to the total weight of the food or beverage product ) specifically, it is a randomly bonded condensation polymer are contemplated , as are all intermediate ranges based on of D - glucose ( in which 1,6 - glycosidic linkages predomi these amounts . For example, beta - glucan may be incorpo- nate ), sorbitol ( in an amount up to 10 % by weight) and one rated in the food or beverage product in an amount of of citric acid or phosphoric acid ( in amounts up to 1 % by between about 0.1 % by weight to about 20 % by weight, 60 weight) . Polydextrose may also contain small amounts of between about 0.5 % by weight to about 20 % by weight, free D - glucose , sorbitol, citric acid and 1,6 - anhydro - D between about 0.5 % by weight to about 10 % by weight, glucose ( levoglucosan ). The polydextrose may have a between about 0.5 % by weight to about 5 % by weight ( e.g. molecular weight in the range of 162 g /mol to 20000 g /mol . between about 0.5 % by weight to about 3 % by weight, or In certain embodiments, 90 % or more of the polydextrose between about 0.75 % by weight to about 2 % by weight) , 65 molecules have a molecular weight between about 504 between about 0.1 % by weight to about 10 % by weight, or g /mol and about 5000 g /mol . In some embodiments , the between about 0.1 % by weight to about 5 % by weight ( e.g. average degree of polymerisation of the polydextrose is 12 . US 10,933,074 B2 15 16 In embodiments of the invention , the average molecular porated into the food or beverage product) the sweet , non weight of the polydextrose is approximately 2000 g /mol . digestible carbohydrate is selected from one or more of In embodiments of the present invention wherein the sorbitol, maltitol , isomalt , isomaltulose, erythritol, xylitol , method comprises incorporating polydextrose into the food D- and L - allose , D - and L - tagatose , lactose , melezitose , D or beverage product, the polydextrose is preferably present 5 and L - arabinose , L - fructose, L - glucose and D- and L - allu in an amount between about 0.1 g and about 40 g per labeled lose . serving of the food or beverage product. All intermediate The one or more of D - glucose , fiber ( e.g. beta - glucan and amounts ( i.e. 1 g , 2 g , 3 g ... 37 g , 38 g , 39 g per labeled polydextrose) and protein may be provided in a syrup serving ) are contemplated , as are all intermediate ranges ingredient or dry ingredient mix , which can be incorporated based on these amounts . 10 within food or beverage products. Alternatively , the polydextrose is incorporated in the food The one or more of D - glucose , fiber ( e.g. beta - glucan and or beverage product in an amount of between about 0.1 % by polydextrose ) and protein may be incorporated into the food weight to about 80 % by weight with respect to the total or beverage product during the manufacturing process . weight of the food or beverage product. All intermediate Alternatively, the one or more of D - glucose , fiber ( e.g. amounts ( i.e. 1 % , 2 % , 3 % ... 77 % , 78 % , 79 % by weight 15 beta - glucan and polydextrose ) and protein may be incorpo relative to the total weight of the food or beverage product) rated into the food or beverage product following the are contemplated , as are all intermediate ranges based on manufacture of said food or beverage product. The one or these amounts . For example, the polydextrose may incor- more of D - glucose , fiber ( e.g. beta -glucan and polydextrose ) porated in the food or beverage product in an amount of and protein may also be incorporated immediately prior to between about 0.1 % by weight to about 70 % by weight, 20 consumption of the food or beverage product . between about 0.5 % by weight to about 70 % by weight (e.g. In other embodiments of the present invention , the sweet, between about 0.5 % by weight to about 50 % by weight) , low - digestible carbohydrate may be provided with one or between about 1 % by weight to about 70 % by weight, more of D - glucose , fiber ( e.g. beta - glucan and polydextrose ) between about 10 % by weight to about 70 % by weight, and protein in a syrup ingredient or dry ingredient mix , between about 20 % by weight to about 70 % by weight, 25 which can be incorporated within food or beverage products, between about 30 % by weight to about 70 % by weight or for example, during or following manufacture, or immedi between about 40 % by weight to about 70 % by weight ( e.g. ately prior to consumption of said food or beverage prod between about 55 % by weight to about 65 % , by weight, or ucts . between about 45 % by weight to about 55 % by weight ). When cooking at home, home cooks will often be fol In embodiments of the present invention wherein the 30 lowing a recipe which calls for sugar ( i.e. sucrose , or table method comprises incorporating only polydextrose into the sugar ). Sweet, low - digestible carbohydrates represent an food or beverage product ( i.e. D - glucose , other fibers and alternative to sugar in many food and beverage applications . protein are not incorporated into the food or beverage From a practical point of view , it is convenient for a home product) the sweet , non - digestible carbohydrate is selected cook to be able to replace the sugar in any given recipe with from one or more of sorbitol, maltitol , isomalt , isomaltulose , 35 the sweet , low - digestible carbohydrate without having to erythritol, xylitol , D- and L - allose , D - and L -tagatose , lac- calculate how much sweet , low - digestible carbohydrate is tose , melezitose , D- and L - arabinose, L - fructose, L - glucose required . Thus, the sweet , low - digestible carbohydrate and and D- and L - allulose . one or more of D - glucose , fiber ( e.g. beta - glucan or poly Another aspect of the present invention relates to the dextrose ) and protein may be incorporated as part of a unexpected finding that protein can improve the gastroin- 40 scoop - for - scoop sweetener, which can be used to replace testinal tolerance of a food or beverage product comprising sucrose on an equivalent volume basis ( i.e. one scoop of the a sweet, low -digestible carbohydrate . mix comprising the sweet, low - digestible carbohydrate and In embodiments of the present invention wherein the one or more of D - glucose , fiber ( e.g. beta - glucan or poly method comprises incorporating protein into the food or dextrose ) and protein is used to replace one scoop of sugar ). beverage product, the protein is present in an amount of 45 In addition to scoop - for - scoop products , there is also about 0.1 g to about 40 g per labeled serving of the food or demand among end users for table -top sweeteners that can beverage product. be used in place of sugar or other nutritive sweeteners . In the In other embodiments, the protein is present in an amount case of table -top products , there is no need for the sweetness of about 0.1 % by weight to about 80 % by weight with to be equivalent to that of sucrose on a volume basis ; instead , respect to the total weight of the food or beverage product. 50 table - top sweeteners are simply supplied with dosage guide The method according to this aspect may further comprise lines, often with reference to a teaspoon ( 5 mL ) of sugar . The incorporating one or more of D - glucose and fiber into the most common use for table - top products is to sweeten food or beverage product. beverages, typically hot beverage products such as tea and The protein may be native or non - native . A native protein coffee . The sweet, low - digestible carbohydrate and one or is a protein that has not been altered by denaturing agents. 55 more of D - glucose , fiber ( e.g. beta - glucan or polydextrose) In contrast , a non - native protein is a protein that has under- and protein may therefore be provided as a table - top sweet gone chemical and / or enzymatic treatment. For example , the ener . protein may be hydrolyzed protein , which is a protein that According to another aspect of the present invention , has been hydrolyzed into its component amino acids . there is provided the use of one or more of D - glucose , fiber In an embodiment of the invention , the protein may be 60 and protein in a method for improving the gastrointestinal one or more of vegetable protein ( e.g. corn , wheat, barley, tolerance of a food or beverage product comprising a sweet, spelt , rye and oat) and milk protein . An example of a protein low - digestible carbohydrate, wherein the method comprises derived from oat is one available from Tate & Lyle under the incorporating one or more of D - glucose , fiber and protein trade name PrOateinTM . into the food or beverage product. In embodiments of the present invention wherein the 65 In an embodiment, there is provided the use of D - glucose method comprises incorporating only protein into the food in a method for improving the gastrointestinal tolerance of or beverage product ( i.e. D - glucose and fiber are not incor- a food or beverage product comprising a sweet , low -digest US 10,933,074 B2 17 18 ible carbohydrate, wherein the method comprises incorpo- In an embodiment, there is provided the use of a compo rating D - glucose into the food or beverage product. sition comprising one or more of beta - glucan and polydex In an embodiment, there is provided the use of fiber in a trose in a method for improving the gastrointestinal toler method for improving the gastrointestinal tolerance of a ance of a food or beverage product comprising a sweet, food or beverage product comprising a sweet , low -digestible 5 low - digestible carbohydrate, wherein the method comprises carbohydrate, wherein the method comprises incorporating incorporating one or more of beta - glucan and polydextrose fiber into the food or beverage product. In a preferred into the food or beverage product. embodiment, there is provided the use of beta - glucan and /or The composition may be incorporated into the food or polydextrose in a method for improving the gastrointestinal beverage product during manufacture . Alternatively, the tolerance of a food or beverage product comprising a sweet , 10 composition may be incorporated into the food or beverage low - digestible carbohydrate, wherein the method comprises product following manufacture . The composition may be incorporating one or more of beta - glucan and / or polydex formulated in any form suitable for including in food or trose into the food or beverage product. beverage products. For example, the composition may be a methodIn an embodiment for improving, there the is gastrointestinalprovided the use tolerance of protein of in a 15 formulated as a syrup, in powder form , as granules, or in a food or beverage product comprising a sweet, low -digestible solution . carbohydrate, wherein the method comprises incorporating In an embodiment, the composition comprises D -glucose . protein into the food or beverage product. The composition may comprise D - glucose in the absence of In an embodiment, there is provided the use of D - glucose fiber and protein . The composition may comprise D - glucose and fiber in a method for improving the gastrointestinal 20 in the absence of beta - glucan , polydextrose and protein. tolerance of a food or beverage product comprising a sweet , In another embodiment, the composition comprises fiber. low - digestible carbohydrate , wherein the method comprises The composition may comprise fiber in the absence of incorporating D - glucose and fiber into the food or beverage D - glucose and protein . The fiber may be beta - glucar ean product. In a preferred embodiment, there is provided the ing that, in certain embodiments , the composition may use of D - glucose and beta - glucan and / or polydextrose in a 25 comprise beta -glucan in the absence of D - glucose , protein method for improving the gastrointestinal tolerance of a and other fibers ( such as polydextrose ). Alternatively, the food or beverage product comprising a sweet , low - digestible fiber may be polydextrose , meaning that, in certain embodi carbohydrate, wherein the method comprises incorporating ments, the composition may comprise polydextrose in the D - glucose and beta - glucan and / or polydextrose into the food absence of D - glucose , protein and other fibers ( such as or beverage product. 30 beta - glucan ). In an embodiment, there is provided the use of D - glucose In another embodiment , the composition comprises pro and protein in a method for improving the gastrointestinal tein . The composition may comprise protein in the absence tolerance of a food or beverage product comprising a sweet , of D - glucose and fiber. The composition may comprise incorporatinglow - digestible Dcarbohydrate - glucose and, whereinprotein theinto method the food comprises or bev- 35 protein in the absence of D - glucose , beta -glucan and poly erage product. dextrose . In an embodiment, there is provided the use of fiber and In a further embodiment, the composition comprises protein in a method for improving the gastrointestinal tol D - glucose and fiber . The composition may comprise D - glu erance of a food or beverage product comprising a sweet , cose and fiber in the absence of protein . The composition low - digestible carbohydrate, wherein the method comprises 40 may comprise D - glucose and beta - glucan in the absence of incorporating fiber and protein into the food or beverage other fibers and protein . The composition may comprise product. In a preferred embodiment, there is provided the D - glucose and polydextrose in the absence of other fibers use of protein and beta - glucan and / or polydextrose in a and protein . The composition may comprise D -glucose , method for improving the gastrointestinal tolerance of a beta - glucan and polydextrose in the absence of other fibers food or beverage product comprising a sweet , low - digestible 45 and protein . carbohydrate, wherein the method comprises incorporating In a further embodiment, the composition comprises protein and beta - glucan and / or polydextrose into the food or D - glucose and protein . The composition may comprise beverage product. D - glucose and protein in the absence of fiber . In an embodiment, there is provided the use of D - glucose , In a further embodiment, the composition comprises fiber fiber and protein in a method for improving the gastrointes- 50 and protein . The composition may comprise fiber and pro tinal tolerance of a food or beverage product comprising a tein in the absence of D -glucose . The composition may sweet , low -digestible carbohydrate, wherein the method comprise beta - glucan and protein in the absence of other comprises incorporating D - glucose , fiber and protein into fibers and D - glucose . The composition may comprise poly the food or beverage product. In a preferred embodiment, dextrose and protein in the absence of other fibers and there is provided the use of D - glucose , protein and beta- 55 D - glucose . The composition may comprise beta - glucan , glucan and / or polydextrose in a method for improving the polydextrose and protein in the absence of other fibers and gastrointestinal tolerance of a food or beverage product D - glucose . comprising a sweet , low - digestible carbohydrate , wherein The composition may comprise D - glucose, fiber and the method comprises incorporating D - glucose , protein and protein . The composition may comprise D - glucose , beta beta - glucan and /or polydextrose into the food or beverage 60 glucan and protein in the absence of other fibers . The product composition may comprise D - glucose , polydextrose and According to another aspect of the present invention , protein in the absence of other fibers . The composition may there is provided the use of a composition comprising one or comprise D - glucose, beta - glucan, polydextrose and protein more of D - glucose , fiber ( e.g. one or more of beta - glucan in the absence of other fibers . and polydextrose ) and protein in a method for improving the 65 The composition may comprise D - glucose and beta gastrointestinal tolerance of a food or beverage product glucan , wherein the weight ratio of D - glucose to beta - glucan comprising a sweet , low - digestible carbohydrate . is between about 5 : 1 to about 20 : 1 . US 10,933,074 B2 19 20 Alternatively, the composition may comprise D - glucose In another embodiment, there is provided the use of a and polydextrose , wherein the weight ratio of D - glucose to combination of D - glucose and beta - glucan for increasing the polydextrose is between about 1:20 to about 20 : 1 ( e.g. about gastrointestinal tolerance of a food or beverage product 2 : 1 to about 20 : 1 ) . comprising a sweet, low - digestible carbohydrate. Further , the composition may comprise beta - glucan and 5 In a further embodiment, there is provided the use of a polydextrose, wherein the weight ratio of polydextrose to combination of D - glucose , beta - glucan and polydextrose for beta - glucan is between about 5 : 1 to about 20 : 1 . increasing the gastrointestinal tolerance of a food or bever In another embodiment, the composition comprises age product comprising a sweet , low - digestible carbohy D - glucose , beta -glucan and polydextrose . drate . 10 According to another aspect , there is provided the use of When the composition comprises D - glucose, it may be a combination of D - glucose and protein for increasing the incorporated into a food or beverage product containing a gastrointestinal tolerance of a food or beverage product sweet , low - digestible carbohydrate such that the weight ratio comprising a sweet, low - digestible carbohydrate . of sweet , low - digestible carbohydrate to D - glucose in the According to another aspect , there is provided the use of food or beverage product is from about 0.5 : 1 to about 10 : 1 , 15 a combination of fiber and protein for increasing the gas for example , from about 1 : 1 to about 5 : 1 , about 1 : 1 to about trointestinal tolerance of a food or beverage product com 4 : 1 , about 1 : 1 to about 3 : 1 , or about 1 : 1 . prising a sweet, low - digestible carbohydrate. When the composition comprises beta - glucan , it may be In an embodiment, there is provided the use of a combi incorporated into a food or beverage product containing a nation of protein and polydextrose for increasing the gas sweet , low - digestible carbohydrate such that the final 20 trointestinal tolerance of a food or beverage product com amount of beta - glucan in the food or beverage product is prising a sweet, low -digestible carbohydrate. between about 0.5 g to about 6 g per labeled serving. Also , In another embodiment, there is provided the use of a when the composition comprises beta - glucan , it may be combination of protein and beta -glucan for increasing the incorporated into a food or beverage product containing a gastrointestinal tolerance of a food or beverage product sweet , low - digestible carbohydrate such that the weight ratio 25 comprising a sweet , low - digestible carbohydrate . of sweet , low - digestible carbohydrate to beta - glucan in the In a further embodiment, there is provided the use of a food or beverage product is from about 100 : 1 to about 5 : 1 , combination of protein , beta - glucan and polydextrose for for example, from about 50 : 1 to about 5 : 1 , about 50 : 1 to increasing the gastrointestinal tolerance of a food or bever about 10 : 1 , about 40 : 1 to about 10 : 1 , about 30 : 1 to about age product comprising a sweet , low -digestible carbohy 20 : 1 , or about 25 : 1 . 30 drate . When the composition comprises polydextrose , it may be According to another aspect , there is provided the use of incorporated into a food or beverage product containing a a combination of D - glucose , fiber and protein for increasing low - digestible carbohydrate such that the final am of the gastrointestinal tolerance of a food or beverage product polydextrose in the food or beverage product is between comprising a sweet , low - digestible carbohydrate . about 0.1 g to about 40 g per labeled serving. 35 In an embodiment, there is provided the use of a combi According to another aspect of the present invention , nation of D - glucose , polydextrose and protein for increasing there is provided the use of D - glucose for increasing the the gastrointestinal tolerance of a food or beverage product gastrointestinal tolerance of a food or beverage product comprising a sweet , low - digestible carbohydrate . comprising a sweet , low - digestible carbohydrate . In another embodiment, there is provided the use of a According to another aspect of the present invention , 40 combination of D - glucose , beta - glucan and protein for there is provided the use of fiber for increasing the gastro- increasing the gastrointestinal tolerance of a food or bever intestinal tolerance of a food or beverage product compris- age product comprising a sweet , low - digestible carbohy ing a sweet, low - digestible carbohydrate . drate . In an embodiment, there is provided the use of beta- In a further embodiment, there is provided the use of a glucan for increasing the gastrointestinal tolerance of a food 45 combination of D - glucose , beta - glucan , polydextrose and or beverage product comprising a sweet , low - digestible protein for increasing the gastrointestinal tolerance of a food carbohydrate . or beverage product comprising a sweet , low - digestible In another embodiment, there is provided the use of carbohydrate. polydextrose for increasing the gastrointestinal tolerance of According to a further aspect of the present invention , a food or beverage product comprising a sweet , low - digest- 50 there is provided one or more of D - glucose , fiber and ible carbohydrate . protein , or a composition comprising one or more of D - glu In a further embodiment, there is provided the use of a cose , fiber and protein , for use in a method for improving the combination of polydextrose and beta - glucan for increasing gastrointestinal tolerance of food and beverage products the gastrointestinal tolerance of a food or beverage product comprising a sweet , low - digestible carbohydrate in accor comprising a sweet, low - digestible carbohydrate . 55 dance with earlier aspects of the invention . According to another aspect of the present invention , In an embodiment, there is provided one or more of there is provided the use of protein for increasing the D - glucose , beta - glucan , polydextrose, and protein , or a gastrointestinal tolerance of a food or beverage product composition comprising one or more of D - glucose , beta comprising a sweet , low - digestible carbohydrate . glucan , polydextrose and protein , for use in a method for According to another aspect , there is provided the use of 60 improving the gastrointestinal tolerance of food and bever a combination of D - glucose and fiber for increasing the age products comprising a sweet , low - digestible carbohy gastrointestinal tolerance of a food or beverage product drate in accordance with earlier aspects of the invention . comprising a sweet , low - digestible carbohydrate. According to another aspect of the present invention , In an embodiment, there is provided the use of a combi- there is provided a food or beverage product comprising a nation of D - glucose and polydextrose for increasing the 65 sweet , low - digestible carbohydrate and one or more of gastrointestinal tolerance of a food or beverage product D - glucose , fiber and protein , wherein the one or more of comprising a sweet , low - digestible carbohydrate . D - glucose , fiber and protein are present in an amount US 10,933,074 B2 21 22 effective to improve the gastrointestinal tolerance of said TABLE 1 - continued food or beverage product. The D - glucose , fiber ( which includes one or more of beta - glucan and polydextrose ) and Doses of D -allulose and D - glucose provided in the study protein may be present in the food or beverage product in the D - Allulose amounts already described herein . 5 D - Allulose dose D - Glucose D - Glucose / dose Grams/ dose D - allulose EXAMPLES Beverage Grams/ day serving Grams/ serving ratio Bev 2 50 25 8.35 1 : 3 Bev 3 70 35 35 1 : 1 The invention will now be illustrated by means of the 70 35 11.65 1 : 3 following examples, it being understood that these are 10 Bev 45 90 45 15 1 : 1 intended to explain the invention , and in no way to limit its Bev 6 90 45 45 1 : 3 scope . Example 1 The beverages were consumed with a meal at breakfast 15 and lunch time . As shown in FIG . 4 , at 90 of D - Allulose Study on the Gastrointestinal Tolerance of per day ( divided into two 45 g / serving doses ) , a 1 : 1 mixture D - Allulose of D - glucose to D - allulose in a beverage appeared superior, with 20 % fewer subjects with recorded tolerance findings -1 A dose escalation study was conducted in a total of 24 subject with loose stool at 1 : 1 vs. 3 subjects with loose stool pre - screened subjects. 18 subjects were treated with 6 sub- 20 when the dose was 3 : 1 . The addition of D - glucose reduced jects acting as the control. D - allulose was presented in a flavored beverage and the beverages were consumed with a loose stool occurrences compared to the first study such that, food at breakfast and lunch so that the total daily dose was at the 70 g D - allulose / d dose , only 10 % of subjects expe divided in half at each serving ( FIG . 1 ) . The control bever rienced loose stools ( c.f. 28 % in the study of Example 1 ) . age contained 25 g of sucrose per serving. 25 In conclusion , the results show that the composition of The beverages were served with breakfast ( slice of cheese foods or beverages to include D - glucose positively affects and lean pocket ) and lunch ( hot pocket ) consumed 4 hrs the gastrointestinal tolerance of low - digestible carbohy apart. Acute treatment protocols were performed with at drates by reducing gastrointestinal symptoms of bloating, least a 3 day washout period between , escalating the daily gas and diarrhea . dose amount at each visit until what was considered a maximum tolerated dose was achieved . Subjective gastro 30 Example 3 intestinal GI symptoms were assessed on a scale of 0-3 ( 0 = no symptoms, 1 = mild symptoms, 2 = moderate symp toms , 3 = severe symptoms) . The six symptoms assessed Study on Gastrointestinal Tolerance were : 1 ) abdominal distension , 2 ) abdominal pains , 3 ) borborygmus, 4 ) increased flatus, 5 ) loose stools , and 6 ) 35 Overview nausea - vomiting. The GI symptoms were assessed at times In this Example, subjects tested 4 different beverages , 0 , 2 , 4 and 24 hours relative to the breakfast meal . consumed in the morning with at least one week washout The doses of allulose tested were 30 g / d ; 50 g / d ; 70 g / dx2 between test days . The beverages were consumed on an ( i.e. repeated once ) ; 60 g / d ( de - escalation ) . Of the 18 test empty stomach , and there was instruction for subjects to subjects, 11 were men and 7 were women . The median age 40 wait 2 hours before having any other food . The primary of all subjects was 48.5 y / o with an age range of 28-78 . outcome was the total gastrointestinal symptom scores over In the study , 28 % of subjects experienced loose stools at 24 - hours for loose stool GI symptom derived from a GI doses of 60 g / d and 70 g / d ( FIG . 2 ) . Additionally gas and symptoms rating diary. bloating were also prevalent accompanying symptoms. The 4 test beverages ( 8 oz./236.6 ml ) were flavoured with 45 a strawberry mix and contained : 1 ) 25 g of D - allulose ; 2 ) 25 Example 2 g of D - allulose and 25 g of D - glucose ; 3 ) 25 g of D - allulose and 1 g of beta - glucan fiber ; or 4 ) 25 g of sucrose . Study on Gastrointestinal Tolerance — D - Allulose Methods Plus Glucose Ten volunteers were instructed with the following infor 50 mation on how to consume the test beverages, monitor A dose escalation study was conducted in 10 test subjects gastrointestinal symptoms and 24 hour stool observations and compared to 2 control subjects. D - allulose was pre- using a Bristol Stool Form : sented with D - glucose in a flavored beverage either at equal The day before the test drink , avoid consumption of foods amounts ( 1 : 1 ) or at an amount of 1 : 3 ( D - glucose : D - allulose ) which are known to cause you GI distress or gas ( see following the same protocol design as the study in Example 55 below ) . 1 ( see Table 1 and FIG . 3 ) . Fast for 10-14 hours overnight prior to consumption of the test drink . TABLE 1 Do not consume other foods for 2 hours after treatment beverage ( water only ) . Doses of D -allulose and D - glucose provided in the study 60 Record all bowel movements using a Bristol Stool Scale D - Allulose diary (Bristol Stool Form ). D - Allulose dose D - Glucose D - Glucose / At 2 , 4 and 24 hours post consumption of the treatment dose Grams/ dose D - allulose beverage, provide the symptom scorning for each of 6 Beverage Grams /day serving Grams/ serving ratio gastrointestinal tolerance questions ( see below ) . Control 0 ( control) 0 0 ( 25 g sucrose ) n /a 65 The subjects were provided with the following examples Bev 1 50 25 25 1 : 1 of gas - producing foods and beverages to avoid : beans ( le gumes; not " green beans ” ) and food items , such as chili , US 10,933,074 B2 23 24 hummus , lentil soup , bean soup , etc ; vegetables such as Improvements were seen when beta - glucan and D - glucose broccoli, cauliflower, cabbage , brussel sprouts , onions , were added to the beverage. Softer stools were found in the mushrooms, artichokes, and asparagus; fruits, such as pears , following order : allulose > allulose + beta -glucan > allulose + D apples , and peaches ; whole grains such as whole wheat and glucose > sucrose . bran ; sodas, fruit drinks ( especially apple juice and pear 5 The number of people reporting symptoms was greatest in juice ) , and other drinks that contain high - fructose corn the allulose only group . Both D - glucose and beta - glucan syrup ; sugar - free candies and foods that contain sugar alco- decreased reports of symptoms compared to allulose only hols , such as xylitol , mannitol, and sorbitol; and foods with beverage overall. There was an observable decrease in supplemental fibers such as , Fiber One® cereals and bars. symptoms in the 2 and 4 hour questions when D - glucose or The subjects were also advised to avoid any other foods 10 beta - glucan was added to the beverages compared to allu that may cause them GI distress or gas during the study day lose alone ( results not shown ). and also the evening before . In conclusion , improvements were seen with beta - glucan On the day of the test , the subjects followed the below set and D - glucose . Softer stools were found in the following of instructions: order : allulose > allulose + beta - glucan > allulose + D 1. Testing start times begin when you start consuming the 15 glucose > sucrose . D - Glucose addition to the beverage also drink ; record date and time you begin on the diary. decreased recordings of gas , abdominal distention and loose 2. Consume the test drink at the same time each week . stools , compared to allulose alone . Beta - glucan addition to a . Consume the entire drink 8 oz . ( 236.6 ml ) drink in the beverage also decreased loose stool symptoms. This data under 15 minutes . demonstrates that, when either D - glucose or oat beta - glucan b . Refill the drink container with water and consume as 20 fiber are consumed together with allulose in a beverage, a chaser. there is a decrease in symptoms created by an acute large c . You may have additional water after 60 minutes as dose of allulose . desired . 3. Record GI symptom scores at 2 , 4 and 24 -hours after The invention claimed is : starting drink consumption. 25 1. A method for improving the gastrointestinal tolerance 4. You may eat a snack or breakfast 2 hours after the test of a food or beverage product comprising D - allulose con drink . sumed by a human subject in need thereof, wherein the 5. Record all bowel movements and the Bristol Stool type method comprises incorporating one or more of D - glucose , during the 24 - hour observation period. fiber or protein into the food or beverage product and 6. Resume normal food consumption for the day ; however 30 whereby one or more symptoms selected from the group avoid foods which you know may cause gastric upset or consisting of abdominal distension , abdominal pains , bor gas for the 24 - hour observation period. borygmus, increased flatus, loose stools , and nausea/ vomit The symptom scoring for the 6 gastrointestinal GI toler- ing are reduced in occurrence and severity when the food or ance questions was assessed by the subjects on the basis of beverage product is consumed by the human subject. the following 4 -point scales : 1 ) Abdominal pains ( 0 ( i.e. 35 2. The method according to claim 1 , wherein the method none ) = no or transient pain ; 1 ( i.e. mild ) occasional aches comprises incorporating a fiber into the food or beverage and pains interfering with some social activities ; 2 ( i.e. product and the fiber is one or more of a beta - glucan or moderate ) = prolonged and troublesome aches and pains polydextrose. causing requests for relief and interfering with many social 3. The method according to claim 1 , wherein the method activities ; and 3 ( i.e. severe ) = severe or crippling pains with 40 comprises incorporating D - glucose into the food or beverage impact on all social activities ) ; 2 ) Nausea and vomiting product. ( 0 = no nausea ; 1 = occasional episodes of short duration ; 4. The method according to claim 3 , wherein the method 2 = frequent and prolonged nausea but no vomiting ; and further comprises incorporating a beta - glucan into the food 3 = continuous nausea with frequent vomiting ) ; 3 ) Borboryg- or beverage product. mus ( 0 = no or transient borborygmus; 1 = occasional trouble- 45 5. The method according to claim 4 , wherein the method some borborygmus of short duration ; 2 = frequent and pro- further comprises incorporating polydextrose into the food longed episodes which can be mastered by moving without or beverage product. impairing social performance; and 3 = continuous borboryg- 6. The method according to claim 3 , wherein the method mus severely interfering with social performance ); 4 ) further comprises incorporating polydextrose into the food Abdominal distention ( 0 = no or transient distention ; 1 = occa- 50 or beverage product. sional discomfort of short duration ; 2 = frequent and pro- 7. The method according to claim 3 , wherein the D - allu longed episodes which can be mastered by adjusting the lose is present in the food or beverage product in a weight clothing ; and 3 = continuous discomfort seriously interfering ratio to D - glucose of from about 0.5 : 1 to about 10 : 1 . with social performance ); 5 ) Increased flatus ( 0 = no 8. The method according to claim 7 , wherein the D -allu increased flatus; 1 = occasional discomfort of short duration ; 55 lose is present in the food or beverage product in a weight 2 = frequent and prolonged episodes interfering with some ratio to D - glucose of from about 1 : 1 to about 3 : 1 . social activities ; and 3 = frequent episodes seriously interfer- 9. The method according to claim 1 , wherein the method ing with social performance ); and 6 ) Loose stools ( O = normal comprises incorporating fiber into the food or beverage consistency; 1 = somewhat loose ; 2 = runny ; and 3 =watery ). product. Results 60 10. The method according to claim 1 , wherein the method The Bristol Stool test scores were scored from 1-7 . Each comprises incorporating beta - glucan into the food or bev subject's scores were averaged for the 24 hour observation erage product. period then averaged per treatment group . The results are 11. The method according to claim 10 , wherein the presented in FIG . 5. The GI symptom scores relating to the method further comprises incorporating polydextrose into 6 GI tolerance questions are presented in FIG . 6 . 65 the food or beverage product. There was a softening effect with the allulose treatment 12. The method according to claim 10 , wherein the compared to the sucrose treatment (negative control ). beta - glucan is oat beta - glucan . US 10,933,074 B2 25 26 13. The method according to claim 10 , wherein the 20. The method according to claim 1 , wherein the method beta - glucan is in the form of a fraction rich in soluble dietary comprises incorporating protein into the food or beverage fibers containing at least about 20 % and up to about 40 % product. beta - glucan ( on a dry weight basis ) of mean molecular 21. The method according to claim 20 , wherein the weight of at least about 800 kDa . 5 method further comprises incorporating one or more of 14. The method according to claim 13 , wherein the D - glucose or fiber into the food or beverage product. beta - glucan is in the form of a fraction rich in soluble dietary 22. The method according to claim 1, wherein the protein fibers containing about 35 % beta - glucan ( on a dry weight is present in an amount of about 0.1 g to about 40 g per basis ) of mean molecular weight of at least about 800 kDa . labeled serving of the food or beverage product . 15. The method according to claim 10 , wherein the 10 23. The method according to claim 1 , wherein the protein beta - glucan is present in an amount between about 0.5 g and is present in an amount of about 0.1 % by weight to about about 6 g per labeled serving of the food or beverage 80 % by weight with respect to the total weight of the food product or beverage product. 24. The method according to claim 1 , wherein the D - al beta16. - glucanThe ismethod present according in an amountto claim of 10about , wherein 0.01 % theby 15 lulose is present in the food or beverage product in a total weight to about 20 % by weight with respect to the total amount from about 1 g to about 100 g per labeled serving. weight of the food or beverage product. 25. A food or beverage product comprising D - allulose and 17. The method according to claim 1 , wherein the method one or more of D - glucose , fiber or protein , wherein the one comprises incorporating polydextrose into the food or bev or more of D - glucose , fiber or protein are present in an 20 amount effective to improve the gastrointestinal tolerance of erage product . said food or beverage product whereby one or more symp 18. The method according to claim 17 , wherein the toms selected from the group consisting of abdominal dis polydextrose is present in an amount of about 0.1 % by tension , abdominal pains , borborygmus, increased flatus , weight about 80 % by weight with respect to the total weight loose stools , and nausea / vomiting are reduced in occurrence of 19.the foodThe ormethod beverage according product .to claim 17 , wherein the 25 and severity when the food or beverage product is consumed polydextrose is present in an amount of about 0.1 g to about by a human subject in need thereof. 40 g per labeled serving of the food or beverage product.