US 20140.044827A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2014/0044827 A1 Mitchell (43) Pub. Date: Feb. 13, 2014

(54) DETARY SUPPLEMENT CONTAINING Publication Classification LYOPHILIZED DARY AND LINOLENIC ACD (51) Int. Cl. A23C 9/52 (2006.01) (71) Applicant: Bodygenex LLC, Hales Corners, WI (52) U.S. Cl. (US) CPC ...... A23C 9/1528 (2013.01) USPC 426/2: 426/586: 426/582: 426/583; 426/580 (72) Inventor: Shawn Mitchell, Hales Corners, WI (US) (73) Assignee: Bodygenex LLC, Hales Corners, WI (57) ABSTRACT (US) (21) Appl. No.: 13/963,016 Described is a dietary Supplement and a corresponding (22) Filed: Aug. 9, 2013 method to maintain the nutritional health of mammals, including humans. The composition includes a dried dairy Related U.S. Application Data product, typically cream, whole milk, reduced milk, cot (60) Provisional application No. 61/681,935, filed on Aug. tage cheese, yogurt, or combinations thereof in combination 10, 2012. with an comprising linolenic acid. US 2014/0044827 A1 Feb. 13, 2014

DIETARY SUPPLEMENT CONTAINING bers in that range. For example, a disclosure of from 1 to 10 LYOPHILIZED DARY AND LINOLENIC should be construed as Supporting a range of from 2 to 8, from ACD 3 to 7, from 1 to 9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth. CROSS-REFERENCE TO RELATED 0007 All references to singular characteristics or limita APPLICATIONS tions of the present invention shall include the corresponding 0001 Priority is hereby claimed to provisional application plural characteristic or limitation, and Vice-versa, unless oth Ser. No. 61/681,935, filed Aug. 10, 2012, which is incorpo erwise specified or clearly implied to the contrary by the rated herein by reference context in which the reference is made. 0008 All combinations of method or process steps as used BACKGROUND herein can be performed in any order, unless otherwise speci 0002. As used herein, “linolenic acid' refers to the two fied or clearly implied to the contrary by the context in which octadecatrienoic acids O-linolenic acid (an omega-3 fatty the referenced combination is made. acid) and Y-linolenic acid (an omega-6 fatty acid), as well as 0009. The methods of the present invention can comprise, esters thereof (such as acyl-linolenates, for example triglyc consist of, or consist essentially of the essential elements and limitations of the products and methods described herein, as eride esters of linolenic acid, and the like). In short, linolenic well as any additional or optional ingredients, components, or acids perse are carboxylic acids with 18-carbon chains and limitations described herein or otherwise useful in formulat three cis double bonds: ing dietary Supplements. 0010. One step in preparing the dietary supplement is to O dry a Suitable dairy component for use in the product. As used 9 6 3 C. o o o () herein, the term “dry” or “drying refers to any method now HO 9 2 15 18 known in the art or developed in the future to convert a liquid C-linolenic acid product into a corresponding dried product Thus, as used (9Z,12Z,15Z)-9,12,15-octadecatrienoic acid herein, drying the dairy product can be accomplished by, for example (and not limitation) evaporation, freeze-drying (i.e., O () lyophilization or cryodesiccation), spray drying, and the like. 6 HO o o o 0011. The dried dairy component is then physically com 6 9 12 bined with one or more comprising linolenic acid and/or Y-linolenic acid its esters. The preferred oils are selected from the group (6Z.97,12Z)-6,9,12-octadecatrienoic acid consisting of oil, grape , poppy seed oil, , , , wheat germ oil, cottonseed 0003 Linolenic acid is a fatty acid found primarily in oil, , , , , Vegetable oils. It is sold as a dietary Supplement for use in oil, , , flaxseed oil (), , humans, principally for treating problems with inflammation , cocoa , , butter, , and and auto-immune diseases. Its efficacy to treat such ailments, combinations thereof. Thus, the combination is a heteroge however, is disputed. neous mixture of the dried dairy component and the liquid (or 0004. The patent literature describes at least one medicinal semi-liquid) oil component. use of linolenic acid. SeeU.S. Pat. No. 7,935,729, issued May 0012. The resulting combination may optionally be pre 3, 2011, to Harbige et al. Harbige et al. describe treating sented in unit dosage form. neurodegenerative diseases by administering to a patient a 0013. In another version of the supplement, the oil too may triglyceride oil containing both Y-linolenic acid and linolenic be dried, so that the combination is in homogeneous powder acid residues as triglyceride ester. The ratio of Y-linolenic acid mixture. to linolenic acid residues at the Sn-2 position of the triglycer 0014. As used herein, the term cottage cheese is used ide is at least 0.8. The amount of Y-linolenic acid residues at broadly to designate any type of fresh cheese curd, whether the sn-2 position is at least 18%. The oil is administered at a curdled with rennet, or added acid, or heat, or a combination dose sufficient to maintain or elevate TGF-31 levels in the of all three. For example, cottage cheese includes traditional, patient at a therapeutic level. U.S.-style cottage cheese (which is typically curdled with rennet) as well as fresh cheese Such as quark (made by warm DETAILED DESCRIPTION ing soured milk until the desired degree of denaturation of 0005 Disclosed herein is a dietary supplement compris milk proteins is met, and then Strained), fromage frais, fresh ing a lyophilized dairy component, Such as lyophilized chevre, and the like. The milk product need not come from cream, whole milk, reduced fat milk, cottage cheese, yogurt, cows, but from any dairy source. Such as goats, sheep, etc. and combinations thereof, which is physically combined into 0015. It is preferred that the dietary supplement be pre a mixture with an oil comprising linolenic acid, and/or esters sented in unit dosage form, such as capsules or tablets. Thus, of linolenic acid, and/or a non-toxic salt of , the dietary Supplement may be manufactured in unit dosage and/or a mixture thereof. Preferred versions of the supple form and may be prepared by any of the methods well-known ment contain C-linolenic acid and/or its esters and/or salts. in the art of the formulation of foods and pharmaceuticals. All 0006 Numerical ranges as used herein are intended to methods include the step of bringing the active compounds include every number and subset of numbers contained into association with one another and optional ingredients, within that range, whether specifically disclosed or not. Fur Such as carriers, accessory ingredients, and the like. In gen ther, these numerical ranges should be construed as providing eral, the formulations are prepared by uniformly and inti Support for a claim directed to any number or Subset of num mately bringing the dried dairy and oil components into asso US 2014/0044827 A1 Feb. 13, 2014 ciation with one another and then, if necessary, shaping the 0023. In some versions of the product and corresponding product into desired unit dosage form. method, the formulation may explicitly exclude components 0016. The recommended in vivo dosage in humans and found naturally in dairy products, such as lactose. Thus, also other mammals depends largely upon the age and general disclosed herein is a dietary Supplement consisting essen health of the patient being treated. Determining the optimum tially of or consisting exclusively of, in combination, a dried dosage for any given mammal is essentially an empirical and dairy product, wherein the dairy product is selected from the ongoing process. The dietary Supplement is administered group consisting of cream, whole milk, reduced fat milk, orally. Because of the differences in ages, size and nature of cottage cheese, yogurt, and combinations thereof, wherein animals, including humans, the amounts which are safe and the dried dairy product is devoid of lactose or has a reduced effective to improve and maintain the health of any given lactose concentration as compared to its natural state; in com individual may vary considerably. Linolenic acid is a natural bination with linolenic acid. food ingredient and it is relatively non-toxic. Thus, the dos 0024. In this context, the phrase “a reduced lactose con ages that can be administered in the method disclosed herein centration as compared to its natural state’ means that at least are not overly critical as long as they are enough to be effec about 50%, or at least about 60%, or at least about 70%, or at tive to maintain the overall nutritional health of the individual least about 80%, or at least about 90% of the lactose naturally being treated, and not so high as to induce a fat intake-related found in the dried dairy product is removed from the dried disorder, Such as a lipidosis. dairy product before the dried dairy product is admixed with 0017 Tablets are made by compression or molding, the linolenic acid. In this fashion, the ultimate composition optionally with one or more accessory ingredients. Com has a reduced lactose concentration. Thus, for example, dis pressed tablets are prepared by compressing the active com closed herein is a dietary Supplement consisting essentially of pound in a free-flowing form, e.g., a powder or granules, or consisting of in combination: (a) lyophilized cottage optionally mixed with accessory ingredients, e.g., binders, cheese, yogurt, or a combination thereof, in which at least lubricants, inert diluents, Surface active or dispersing agents, 50% of naturally occurring lactose has been removed; in using conventional tabletting machinery. Molded tablets may combination with (b) flaxseed oil (linseed oil). Or, for be made by molding a mixture of the combination neator with example, a dietary Supplement consisting essentially of or a suitable carrier, again using conventional and well-known consisting of, in combination: (a) a dried dairy product, molding equipment. wherein the dairy product is selected from the group consist 0018. In addition to the aforementioned ingredients, the ing of cream, whole milk, reduced fat milk, cottage cheese, formulations of this invention may further include one or yogurt, and combinations thereof, in which at least 50% of more optional accessory ingredient(s) utilized in the art of naturally occurring lactose has been removed; in combination dietary formulations, e.g., diluents, buffers, flavoring agents, with (b) linolenic acid. colorants, binders, Surface active agents, thickeners, lubri 0025. It has been found, quite unexpectedly, that the com cants, Suspending agents, preservatives (including anti-oxi bination of dairy and linolenic acid greatly improves the dants) and the like. general nutritional health and metabolism of mammals, 0019. The dosage may also be carried within an orally including humans. Thus, the composition and method tolerated capsule. Such as a Caplique-brand capsule. described herein are useful as dietary Supplements to improve 0020. A suitable effective dose for most conditions ranges and maintain the nutritional health of humans and other mam from about 1 mg/kg body weight to about 10 g/kg body mals. The compositions described herein may be formulated weight per day, and is preferably in the range of from about 10 in unit dosages Suitable for human and/or veterinarian uses. to about 1000 mg/kg body weight per day, or about 100 to What is claimed is: about 500 mg/kg body weight per day. The total daily dose 1. A dietary Supplement comprising, in combination: may be given as a single dose, multiple doses, e.g., two to six (a) a dried dairy product, wherein the dairy product is times per day, or by intravenous infusion for a selected dura Selected from the group consisting of cream, whole tion. Dosages above or below the above-cited ranges are milk, reduced fat milk, cottage cheese, yogurt, and com within the scope of the invention and Such dosages may be binations thereof, in combination with administered to individual Subject if the circumstances so (b) an oil comprising linolenic acid. dictate. 2. The dietary Supplement according to claim 1, wherein 0021 For example, in a 75 kg mammal, a typical daily the oil is lyophilized. dosage might fall with the range of from about 100 mg to about 100 g per day. If discrete multiple doses are indicated, 3. The dietary Supplement according to claim 1, in unit treatment might typically comprise 4 equal fractional doses dosage form. given at 8 hour intervals to Supply the total daily dosage. 4. The dietary supplement of claim 1, wherein the oil is 0022. Also disclosed herein is a method of improving the selected from the group consisting of safflower oil, grape seed nutritional status of a mammal, including a human, compris oil, poppy seed oil, Sunflower oil, hemp oil, corn oil, wheat ing administering to the mammal a dosage of from about 1 germ oil, , soybean oil, walnut oil, Sesame oil, mg/kg body weight to about 10 g/kg body weight per day of rice bran oil, pistachio oil, peanut oil, canola oil, flaxseed oil a dietary Supplement comprising, in combination a dried (linseed oil), olive oil, palm oil, , macadamia oil, dairy product, wherein the dairy product is selected from the butter, coconut oil, and combinations thereof. group consisting of cream, whole milk, reduced fat milk, 5. The dietary Supplement according to claim 4, wherein cottage cheese, yogurt, and combinations thereof; in combi the oil is lyophilized. nation with an oil comprising linolenic acid. In the preferred 5. The dietary Supplement according to claim 4, in unit version of the method, the administered supplement com dosage form. prises lyophilized cottage cheese, yogurt, or a combination 7. The dietary supplement of claim 1, wherein the oil thereof; in combination with flaxseed oil (linseed oil). comprises flaxseed oil (linseed oil). US 2014/0044827 A1 Feb. 13, 2014

8. The dietary supplement according to claim 7, wherein 12. The method according to claim 11, wherein the oil is the oil is lyophilized. lyophilized. 9. The dietary supplement according to claim 7, in unit 13. The method according to claim 11, in unit dosage form. dosage form. 14. The method according to claim 11, wherein the oil is 10. A dietary Supplement comprising, in combination: selected from the group consisting of safflower oil, , poppy seed oil, Sunflower oil, hemp oil, corn oil, wheat (a) lyophilized cottage cheese, yogurt, or a combination germ oil, cottonseed oil, soybean oil, walnut oil, Sesame oil, thereof; in combination with rice bran oil, pistachio oil, peanut oil, canola oil, flaxseed oil (b) flaxseed oil (linseed oil). (linseed oil), olive oil, palm oil, cocoa butter, macadamia oil, 11. A method of improving the nutritional status of a mam butter, coconut oil, and combinations thereof. mal, including a human, comprising administering to the 15. A method of improving the nutritional status of a mam mammal a dosage of from about 1 mg/kg body weight to mal, including a human, comprising administering to the about 10 g/kg body weight per day of a dietary Supplement mammal a dosage of from about 1 mg/kg body weight to comprising, in combination: about 10 g/kg body weight per day of a dietary Supplement (a) a dried dairy product, wherein the dairy product is comprising, in combination: Selected from the group consisting of cream, whole (a) lyophilized cottage cheese, yogurt, or a combination milk, reduced fat milk, cottage cheese, yogurt, and com thereof; in combination with binations thereof, in combination with (b) flaxseed oil (linseed oil). (b) an oil comprising linolenic acid. k k k k k