US 2012025 1512A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2012/0251512 A1 Farmer et al. (43) Pub. Date: Oct. 4, 2012 (54) PROBOTC SPORTS NUTRITION Related U.S. Application Data COMPOSITIONS (60) Provisional application No. 61/469.924, filed on Mar. 31, 2011. (75) Inventors: Sean Farmer, Miami, FL (US); David Keller, University Heights, Publication Classification OH (US); Andrew R. Lefkowitz, (51) Int. Cl. Mayfield Heights, OH (US) A6II 35/74 (2006.01) A6IP 2L/00 (2006.01) (73) Assignee: Ganeden Biotech, Inc., Mayfield A2.3L L/48 (2006.01) Heights, OH (US) (52) U.S. Cl. ........................................ 424/93.46; 426/61 (21) Appl. No.: 13/434,401 (57) ABSTRACT The present application relates to nutritional compositions (22) Filed: Mar. 29, 2012 comprising lactic acid-producing bacteria. US 2012/025 1512 A1 Oct. 4, 2012 PROBOTC SPORTS NUTRITION benefit to individuals that are suffering from or at risk of COMPOSITIONS developing a muscle wasting condition, e.g., cachexia, as a result of disease such as cancer or infection. RELATED APPLICATIONS 0007. The invention provides a composition comprising a 0001. This application claims the benefit of priority under sports nutrition composition and an isolated Bacillus coagul 35 U.S.C. S119(e) to U.S. Provisional Application No. lans spore (e.g., in an amount of 1x10° to 1x10" colony 61/469.924, filed Mar. 31, 2011, which is incorporated herein forming units (CFU) of Bacillus coagulans per unit dose. For by reference in its entirety. example, the isolated Bacillus coagulans comprise between about 0.000001% to about 50% by weight of the composition, FIELD OF THE INVENTION e.g., about 1%, about 10%, about 20%, about 30%, about 40%, or about 50% by weight of the composition. For 0002 The present application relates to sports nutrition example, the isolated Bacillus coagulans comprise between compositions comprising lactic acid-producing bacteria. about 0.00001% and about 25% by weight of the composi tion, e.g., about 1%, about 2%, about 3%, about 4%, about BACKGROUND OF THE INVENTION 5%, about 6%, about 7%, about 8%, about 9%, about 10%, 0003. The gastrointestinal microflora plays a number of about 11%, about 12%, about 13%, about 14%, about 15%, Vital roles in maintaining gastrointestinal tract function and about 16%, about 17%, about 18%, about 19%, about 20%, overall physiological health. The growth and metabolism of about 21%, about 22%, about 23%, about 24%, or about 25% the many individual bacterial species inhabiting the gas by weight of the composition. In one example, one unit dose, trointestinal tract depend upon the substrates available to e.g., one serving, comprises one billion CFU Bacillus coagul them, most of which are derived from the diet. lans and 20-25 grams of protein (e.g., 23 grams of whey 0004 Probiotic organisms are non-pathogenic, non-toxi protein) in 30 grams of powder. The balance of the composi genic microorganisms that are beneficial to the host organ tion optionally comprises nutritionally inactive ingredients ism. Since probiotics do not generally permanently colonize Such as excipients, fillers, preservatives or nutritionally active the host, they are typically ingested regularly for health pro ingredients such as vitamins or minerals. moting properties to persist. 0008. The invention also provides bacterial species including Bacillus coagulans, e.g., Bacillus coagulans ham SUMMARY OF THE INVENTION mer, preferably Bacillus coagulans hammer Strain Accession 0005. The invention is based on the discovery that lactic No. ATCC 31284, or one or more strains derived from Bacil acid-producing bacteria, particularly Bacillus coagulans, lus coagulans hammer strain Accession No. ATCC 31284 improve the absorption of protein compositions as well as (e.g., ATCC Numbers: GBI-20, ATCC Designation Number micronutrient compositions. The microorganisms, e.g., PTA-6085; GBI-30 or BC, ATCC Designation Number spores remain viable, retain their beneficial probiotic proper PTA-6086; and GBI-40, ATCC Designation Number PTA ties, and increase metabolism and/or absorption of protein in 6087; see U.S. Pat. No. 6,849,256 to Farmer). sports nutrition compositions. Unlike other probiotic bacteria 0009 Optionally, the isolated Bacillus coagulans is in the that die in the stomach or Small intestine, the probiotic organ form of a spore. Alternatively, the isolated Bacillus coagulans isms described herein, e.g., Bacillus coagulans strain GBI-30 is in the form of a vegetative cell. In another aspect, the or BC, ATCC Designation Number PTA-6086, germinate isolated Bacillus coagulans is in the form of a mixture of in the stomach and/or Small intestine. Accordingly, the inven Vegetative cells and spores. The Bacillus coagulans is pre tion describes probiotic sports nutrition compositions. The dominantly in spore form, e.g., about 75%, about 80%, about invention provides an isolated Bacillus coagulans bacterium 85%, about 90%, about 95%, about 96%, about 97%, about (e.g., a spore) in sports nutrition compositions. In some cases, 98%, about 99%, or about 100% spores. Alternatively, the the composition comprises at least 15% protein. For example, Bacillus coagulans is predominantly in vegetative form, e.g., the composition comprises at least 15%, at least 20%, at least about 75%, about 80%, about 85%, about 90%, about 95%, 25%, at least 30%, at least 35%, at least 40%, at least 45%, at about 96%, about 97%, about 98%, about 99%, or about least 50%, at least 55%, at least 60%, at least 65%, at least 100% vegetative cells. 70%, at least 75%, at least 80%, at least 85%, at least 90%, at 0010 Provided is an isolated Bacillus coagulans and a least 95%, at least 98%, at least 99% or more of a purified or sports nutrition composition. In some cases, the compositions processed protein (e.g., protein extracted from a food-stuff) described herein comprise a large amount of calories per unit and a Bacillus coagulans spore. dose to assista Subject in gaining weight, e.g., muscle weight 0006. The compositions described herein are suitable for or fat weight. A unit dose of the compositions described consumption by a mammal, e.g., any mammal, e.g., a human, herein is the amount of composition administered to a con a primate, a mouse, a rat, a dog, a cat, a cow, a horse, or a pig. Sumer in a single dose, i.e., one serving. Unit-dose packaging In a preferred embodiment, the mammal is a human. For is the packaging of a single dose, e.g., in a non-reusable example, the invention includes a method of enhancing lean container. For example, a unit dose refers to a physically muscle development or increasinglean body mass by admin discrete unit Suitable as unitary dosages for an individual, istering to a Subject a composition comprising a Bacillus each unit containing a predetermined quantity of active mate coagulans spore in a composition comprising at least 85% rial calculated to produce the desired therapeutic effect, in purified, processed, and/or isolated protein. The Subject is a association with a suitable pharmaceutical carrier, diluent, or human being that desires to increase muscle development, excipient. Suitable packaging includes single or multiple unit strength, or lean body mass, or an animal, e.g., livestock or dosages. performance animal Such as a work animal or a racehorse, for 0011 Compositions that provide a large amount of calo which an increase in muscle development or strength is ries to assist a subject in gaining weight are referred to as desired. The compositions are also useful to confer clinical “weight gainers. In these cases, the composition comprises US 2012/025 1512 A1 Oct. 4, 2012 between about 100 and about 10,000 food Calories (kcal) per min A, Vitamin C, calcium, iron, vitamin D. Vitamin E, thia unit dose (i.e., serving), e.g., between 250 and 5,000 kcal, min, riboflavin, niacin, vitamin B6, folate, vitamin B12, between 500 and 3,000 kcal, between 750 and 2,500 kcal, or biotin, pantothenic acid, phosphorus, iodine, magnesium, between 1,000 and 2,000 kcal, e.g., about 1,000 kcal, about Zinc, Selenium, copper, manganese, chromium, and molyb 1,100 kcal, about 1,200 kcal, about 1,300 kcal, about 1,400 denum. kcal, about 1,500 kcal, about 1,600 kcal, about 1,700 kcal, 0015. An exemplary composition comprises glucose poly about 1,800 kcal, about 1,900 kcal, or about 2,000 kcal. One mer, a protein blend (i.e., whey protein concentrate, whey exemplary amount of calories is 1,230 kcal. Alternatively, the protein isolate, egg albumin, milk protein isolate, and par compositions do not comprise a large amount of calories. For tially hydrolyzed whey protein), rice protein concentrate, example, the compositions comprise between about 10 and brown rice concentrate, taurine, L-glutamine, non-dairy 500 kcal, e.g., between about 20 and 250 kcal, between about creamer (i.e., Sunflower oil, corn Syrup Solids, Sodium casein 50 and 200 kcal, or between about 100 and 150 kcal, e.g., ate, mono- and diglycerides, dipotassium phosphate, trical about 100 kcal, about 110 kcal, about 120 kcal, about 130 cium phosphate, Soy lecithin, and tocopherols), natural and kcal, about 140 kcal, or about 150 kcal. One exemplary artificial flavors, Xantham gum, calcium citrate, potassium amount of calories is about 150 kcal. citrate, dipotassium phosphate, cellulose gum, tricalcium 0012 Preferably, the composition comprises protein. For phosphate, magnesium aspartate, rice starch, carrageenan, example, the protein comprises about 1% to about 99% by Vitamin-mineral blend (i.e., ascorbic acid, niacinamide, d-Al weight of the composition, e.g., about 5%, about 10%, about pha tocopheryl Succinate, d-calcium pantothonate, Zinc cit 15%, about 20%, about 25%, about 30%, about 35%, about rate, pyridoxine hydrochloride, ferrous fumarate, thiamine 40%, about 45%, about 50%, about 55%, about 60%, about mononitrate, riboflavin, manganese amino acid chelate, beta 65%, about 70%, about 75%, about 80%, about 85%, about carotene, copper gluconate, folic acid, biotin, potassium 90%, or about 95% by weight of the composition.