Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
1998-12-17
2001-04-24
Russel, Jeffrey E. (Department: 1653)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C424S439000, C426S069000, C426S648000, C426S657000, C514S021800
Reexamination Certificate
active
06221836
ABSTRACT:
TECHNICAL FIELD
The parent applications relate generally to a composition for and method of enhancing the protein concentration or muscle mass of a mammal. This application is also directed to pyruvate and anabolic protein compositions, however, the method of use of the composition is directed to fat and weight loss in a mammal and to decreasing the percent body fat in a mammal. More specifically, the present invention relates to a composition which comprises pyruvate and/or derivatives of pyruvate and a novel blend of proteins and/or amino acids that possesses an amino acid profile that is similar to the amino acid profile of human muscle tissue. The method of the present invention comprises administering to a mammal in need of increasing its rate of fat loss or decreasing the percent body fat, a composition comprising pyruvate and a source of amino nitrogen having specific types and levels of amino acids. The method of this invention results in a synergistic increase of fat loss while at the same time lowering the deposition of body fat. The invention is also directed to the anabolic protein compositions themselves and their use to increase the muscle mass of a mammal while decreasing the percent body fat.
BACKGROUND ART
Athletes engage in strenuous training to accomplish the goals of their sport. People desiring to decrease their percent body fat and lose weight also engage in strenuous exercise. This strenuous training essentially amounts to trauma to the body, in that the human body interprets every strenuous work-out as a threat to its survival. It is known that muscle damage, caused by training, releases the catabolic hormone prostaglandin-E2. Training also causes the release of adrenocorticotropin (ACTH), which is a pituitary hormone. The presence of increased levels of ACTH increases the production of the catabolic hormone cortisol. Cortisol is also known as hydrocortisone, which is a glucocorticoid of the adrenal cortex that is a derivative of cortisone. Hydrocortisone is sometimes used in the treatment of rheumatoid arthritis. Thus, cortisol is a naturally occurring anti-inflammatory steroid. This catabolic hormone results in the release of amino acids from muscle tissue and prevents absorption of glucose. Cortisol, as a catabolic stress hormone, cannibalizes muscle tissue. High cortisol levels also result in the breakdown of connective tissue, lowered immunity and reduced muscle RNA synthesis. While cortisol may be a detriment to the athlete, scientists have conjectured that when the human body is stressed or traumatized, it triggers a “fight or flight” survival response. The biological design of cortisol is such that when a human is threatened, cortisol levels rise and mobilize the body for action by breaking down fat and muscle stores for emergency energy. Cortisol also reduces swelling in the event of injury. After the threat or trauma has subsided, cortisol levels return to normal. The cortisol-stress relationship is designed for intermittent physical threats and not the constant stimulation provided by today's aggressive athletes and fat loss fanatics. Ongoing training results in cortisol levels that do not return to normal for extended periods of time and thereby result in the breakdown or loss of muscle tissue.
After strenuous exercise, muscle tissue enters a stage of rapid nitrogen absorption in the form of amino acids and small peptides in order to rebuild the muscle fibers, grow and add new muscle fibers. During this period of repair and growth, it is important that the muscle cells have available to them sufficient levels of nitrogen in the form of amino acids. While the total level of amino nitrogen is important, the ratios of the various amino acids to each other is even more important.
Athletes and dieters that over-train sometimes enter into a catabolic condition. Muscle catabolism occurs when the athlete or dieter enters a negative nitrogen balance. People on diets usually have a negative nitrogen balance and therefore lose muscle when they lose weight. In contrast, a positive nitrogen balance means the animal has enough nitrogen left over to synthesize muscle proteins.
Various organizations have propounded a list of essential amino acids which are required on a daily basis for proper nutrition. These amino acid requirements vary throughout the growth cycle of all animals. Human muscle tissue is made up of specific amino acids and at specific ratios. If any of these amino acids are missing or deficient, the muscles will not grow, will grow slowly or may even begin to breakdown. However, if the animal is supplied with adequate amounts of protein that contain all of the muscle amino acids, this protein or source of consumed amino nitrogen will be able to support rapid muscle recovery and growth.
The amino acids leucine, isoleucine and valine are the branched chain amino acids and are necessary for a positive nitrogen balance and muscle growth. The branched chain amino acids are lost at significant levels during strenuous exercise and therefore it is critical that they be available during the anabolic state.
The present invention is based in part, upon the discovery that the use of pyruvate in combination with an anabolic protein composition, produces a synergistic effect in increasing the lean body mass or muscle tissue of a mammal consuming same while at the same time decreasing the deposition of fat in the body. The inventive compositions are also effective for increasing the rate of fat loss and decreasing the percent body fat in the mammal and under the proper conditions of caloric intake and exercise results in an overall weight loss in the mammal without significant loss of muscle tissue. The anabolic protein composition itself, when administered in combination with a hypercaloric diet and strenuous exercise, has been found to decrease the percent body fat in a mammal while increasing muscle mass, however, the mammal actually gains weight.
As used herein and the claims, the term “pyruvate” means any salt or ester of pyruvic acid. Pyruvic acid has the formula:
Pyruvic acid is a colorless liquid with an odor resembling that of acetic acid and has a melting point of 13° C. Pyruvic acid is an intermediate in the breakdown of sugars to alcohol by yeast. The mineral salts of pyruvic acid, such as magnesium pyruvate or calcium pyruvate or mixtures thereof are useful in the present invention. Sodium pyruvate is not especially preferred as it is known that sodium is associated with various negative medical conditions such as high blood pressure, water retention and heart disease. Further, certain athletes, such as bodybuilders, desire to present a defined visual image of their body which shows muscle definition and thus, the water retention properties of the sodium salt are not beneficial. Pyruvate precursors in the form of pyruvamides or pyruvyl-amino acids are also useful in the present invention. Pyruvyl-glycine and pyruvyl-glutamine are representative of useful pyruvyl-amino acids. Another pyruvate precursor is pyruvyl-creatine. Pyruvyl-creatine is a covalently linked adduct of pyruvic acid and creatine.
Pyruvate has a number of useful applications in medicine. Pyruvate has been described for retarding fatty deposits in livers (U.S. Pat. No. 4,158,057); for treating diabetes (U.S. Pat. No. 4,874,790); for retarding weight gain (U.S. Pat. Nos. 4,812,879, 4,548,937, and 4,351,835); to increase body protein concentrations in a mammal (U.S. Pat. No. 4,415,576); for treating cardiac patients to increase the cardiac output without accompanying increase in cardiac oxygen demand (U.S. Pat. No. 5,294,641); for extending athletic endurance (U.S. Pat. No. 4,315,835); for retarding cholesterol increase (U.S. Pat. No. 5,134,162); for inhibiting growth and spread of malignancy and retarding DNA breaks; and for inhibiting generation of free radicals. All of these references are incorporated herein by reference.
U.S. Pat. No. 4,981,687 discloses compositions and methods for achieving improved physiological response to exercise. More specifically, this patent
Beale Paxton K.
Nickey Donald O.
Williamson Millard F.
Casey Sean M.
Nickey Donald O.
Paxton King Beale
Russel Jeffrey E.
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