Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2000-09-21
2003-09-16
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C514S561000, C514S440000
Reexamination Certificate
active
06620425
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to food supplements which comprise lipoic acid or derivative thereof and creatine or a derivative thereof, and to methods for supplementing the diet of an athlete and methods for enhancing an athlete's muscle size or strength, which methods employ these food supplements.
BACKGROUND OF THE INVENTION
Creatine (also known as N-methyl-N-guanyl glycine or (alpha methyl guanido) acetic acid) is an amino acid compound produced naturally in the liver and kidneys and obtained from food such as meat and fish. Food supplements containing creatine, typically creatine monohydrate, are commonly used by athletes to allow them to train harder and enhance muscle size and strength. Various commercial products containing creatine monohydrate are available.
Lipoic acid (also known as alpha-lipoic acid, thioctic acid or 6,8-dithio octanoic acid) is a nutrient that the human body makes in minute quantities and may be obtained from yeast and liver. Studies have shown that lipoic acid can significantly increase the body's utilization of blood sugar in type II diabetics and that lipoic acid may increase the metabolic clearance rate of glucose by 50% in diabetics. In Europe, lipoic acid has been used as a substitute for insulin in the treatment of Type II diabetes.
Food supplements for enhancing an athlete's muscle size and strength have become popular substitutes for steroids and other drugs in various sports and body building regimes. However, as athletes continually strive for improved performance, there is a continuing need for non-steroid containing aids for improving muscle size and strength.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to provide new food supplements. It is a more specific object of the invention to provide food supplements particularly adapted for supplementing the diet of an athlete. It is another object to provide food supplements which may enhance an athlete's muscle size or strength. It is a further object of the invention to provide non-steroid containing food supplements and to provide food supplements which may be conveniently administered to the diet of an athlete.
These and additional objects are provided by the food supplements and methods according to the present invention. The food supplements comprise lipoic acid or a derivative thereof, for example a salt or ester thereof, and creatine or a derivative thereof, for example a hydrate, salt or ester thereof. The food supplements may optionally, and preferably, further comprise dextrose. It has been determined that such food supplement compositions are advantageous for supplementing the diet of an athlete and may provide surprising enhancement of an athlete's muscle size or strength when administered to an athlete's diet. These and additional objects and advantages will be more fully apparent in view of the following detailed description.
DETAILED DESCRIPTION
The food supplement compositions of the present invention comprise lipoic acid or a derivative thereof and creatine or a derivative thereof. Creatine and hydrates thereof, particularly creatine monohydrate, are known to improve and/or enhance muscle size and/or strength. The food supplements and methods of the present invention may provide further and significant muscle size and strength enhancement or improvement as compared with supplements and methods employing only creatine or a hydrate thereof. Although the present invention is not to be limited by any theoretical explanation, it is believed that insulin is a primary factor that stimulates glucose and creatine transport into the muscle cells and that the lipoic acid both mimics and enhances the actions of insulin in glucose and creatine transport into the muscle cells. In preferred embodiments, the compositions further include dextrose which has been shown to stimulate insulin action.
The food supplements comprise lipoic acid or a derivative thereof, for example a salt or ester thereof. Suitable salts include, but are not limited to, alkali and alkaline earth metal salts, for example sodium, potassium or calcium salts, while suitable esters include, but are not limited to, alkyl esters, for example, methyl, ethyl or propyl esters, or lactone esters.
The food supplement compositions further comprise creatine or a derivative thereof, for example a hydrate, salt or ester thereof. Commercially available creatine derivatives include creatine monohydrate, other creatine hydrates, creatine citrate and creatine pyruvate. The creatine which is employed in the food supplement compositions of the present invention preferably comprises creatine monohydrate, commercially available from various sources. It is similarly preferred that the creatine, creatine monohydrate or other creatine derivative is a pharmaceutical-grade material. As set forth above, the food supplement compositions also preferably further comprise dextrose (glucose), with pharmaceutical-grade dextrose being preferred.
The food supplement compositions of the present invention may be provided in liquid or powder form, with powders suitable for mixing with water or other liquids being preferred. The food supplement compositions in powder or granular form may be provided in accordance with customary processing techniques, for example as spray dried powders, or the like. Owing to the lipoic acid component, the food supplement compositions generally exhibit an acidic pH value.
The lipoic acid or salt, ester or other derivative thereof is employed in the food supplement compositions according to the present invention in an amount sufficient to increase creatine transport into the muscle cells. In a preferred embodiment, the food supplement compositions comprise from about 0.1 mg to about 10 mg lipoic acid or derivative thereof per gram of supplement and from about 0.01 g to about 0.5 g of creatine, preferably creatine monohydrate, or derivative thereof, per gram of supplement. In further preferred embodiments, the food supplement compositions comprise from about 0.5 mg to about 5 mg lipoic acid derivative thereof per gram of supplement and from about 0.05 g to about 0.25 g of creatine or derivative thereof per gram of supplement. Even more preferably the food supplement compositions comprise from about 1 mg to about 3 mg lipoic acid, salt, ester or other derivative thereof per gram of supplement and from about 0.05 g to about 0.2 g of creatine, creatine monohydrate or other derivative thereof per gram of supplement. Food supplement compositions further comprising dextrose preferably include the dextrose in an amount sufficient to stimulate insulin secretion and preferably the food supplement compositions comprise from about 0.1 g to about 0.9 g dextrose per gram of supplement. In further preferred embodiments, the food supplement compositions comprise from about 0.4 g to about 0.9 g dextrose per gram of supplement, and more preferably comprise from about 0.5 g to about 0.8 g dextrose per gram of supplement. Most preferably, the food supplement compositions comprise about 0.75 g dextrose per gram of supplement.
The food supplement compositions according to the present invention may further contain additional components to further increase the speed at or ease with which creatine enters the bloodstream and subsequently the muscle tissue, or to otherwise enhance the effects of the creatine in the body. For example, additional amino acids may be included in the food supplement compositions. Suitable amino acids include, but are not limited to, glutamine, alanine, taurine, carnitine, acetyl-L-carnitine, and the like. These additional amino acids may stimulate cell volumization and protein synthesis and therefore provide further advantages to increasing muscle strength and/or size. These amino acids may be employed individually or in various combinations and in amounts customary in the art, for example in the range of from about 0.01 mg to about 100 mg per gram of food supplement.
In a further preferred embodiment, the food supplement composition
Kenyon & Kenyon
Muscletech Research and Development Inc.
Page Thurman K.
Pulliam Amy E
LandOfFree
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