Compositions and methods for enhancing protein anabolism and...

Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Heavy metal or compound thereof

Reexamination Certificate

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C514S400000, C514S561000, C514S562000, C514S565000

Reexamination Certificate

active

06203820

ABSTRACT:

FIELD OF THE INVENTION
The present invention is directed to amino acid compositions useful for enhancing protein anabolism and detoxification.
BACKGROUND OF THE INVENTION
For the last century, the role of vitamins, minerals and essential fatty acids as dietary necessities has been progressively recognized, and supplementation of these nutrients is becoming accepted procedure. Conventional wisdom dictates that dietary intake of between about 30 and 55 grams of protein per day ensures adequate protein for all of the body's functions. In the treatment of protein-deficient patients, it has been found that free form amino acids are superior to maintain sufficient protein levels as compared to protein supplied in complex large molecules. Dietary proteins are not used directly but must be broken down into their constituent individual amino acids in order to be absorbed and utilized by the body. Free form amino acids, in contrast, are individual, single amino acids with no fillers or allergens, and are immediately absorbable by the gut. Upon absorption, the amino acids are carried rapidly in the blood plasma to the cells where they are used or stored. Free amino acids are the building blocks of more complex protein molecules that perform structural or functional roles in tissue. Free form amino acids are presently commercially available.
The amino acid proportions of the blood plasma differ significantly from the profiles of either food proteins or the various body proteins. Pools of amino acids in body tissues are needed for normal anabolic function. This pool is normally replaced by the blood's supply of amino acids. The blood, in turn, draws from pools of free amino acids in other tissues to replace what has been used. Therefore plasma concentrations of amino acids remain relatively constant even the supply through dietary sources is deficient for any reason. Thus, the standard accepted total protein tests of the plasma do not provide an early warning of protein and amino acid deficiencies.
Excess of some amino acids can produce results as detrimental as some deficiencies. Balance in the use of amino acids is of the greatest importance. Thus, a need exists for a superior nutritional formulation that can be used to provide amino acids for enhancing protein anabolism.
Another concern is detoxification, namely, the removal of toxic substances such as alcohol and pesticides from the body. Detoxification occurs in the liver in two phases. During Phase I, the liver cells secrete cytochrome P-450 enzymes, which convert waste products to more soluble forms so that they can be excreted by the colon and kidneys. During Phase II, glutathione and other enzymes in the liver corral free radicals, heavy metals, and some toxic wastes and remove them from the body. Critical to this process is the conversion of sulfites to sulfates. Molybdenum is a component of enzymes that assist in this conversion. Thus, a need also exists for a nutritional formulation that provides a sufficient supply of molybdenum to create the necessary enzymes to assist with Phase II detoxification.
SUMMARY OF THE INVENTION
The present invention is directed to a composition for enhancing protein anabolism. The composition comprises molybdenum and at least two amino acids selected from the group consisting of L-arginine, L-cystine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-threonine, L-tryptophan, L-tyrosine, and L-valine. Preferably the composition further comprises creatine monohydrate and/or sulfur, preferably in the form of methylsulfonylmethane.
It is desirable to include all of the above-listed amino acids in the composition. In a particularly preferred embodiment, the composition comprises, based on the total weight of the composition:
about 6% to about 9% by weight L-arginine,
about 2% to about 4% by weight L-cystine,
about 1.5% to about 3.5% by weight L-histidine,
about 6% to about 9% by weight L-isoleucine,
about 8% to about 12% by weight L-leucine,
about 6% to about 8% by weight L-lysine,
about 2.5% to about 4.5% by weight L-methionine,
about 5.5% to about 7.5% by weight L-phenylalanine,
about 4.5% to about 6.5% by weight L-threonine,
about 4% to about 6% by weight L-tyrosine,
about 7% to about 10% by weight L-valine,
about 0.001% to about 0.03% by weight molybdenum,
about 3% to about 30% by weight creatine monohydrate, and
about 5% to about 45% by weight methylsulfonylmethane. Preferably the amino acids are all free form amino acids. Alternatively, the amino acids can be provided in the form of powdered egg white or powdered milk, for example, in the event that free form amino acids are not available. When the amino acids are provided in this converted form, the composition preferably further comprises a proteolytic enzyme.
The composition of the invention is provided in the form of a powder, which is preferably encapsulated in a gelatin capsule.
The invention is also directed to a method for enhancing protein anabolism in a patient comprising administering to the patient an effective amount of a composition as described above. The composition is preferably administered orally. Preferably the composition is administered to the patient in an amount of from about 1.5 grams/day to about 15 grams/day, more preferably in an amount of from about 3 grams/day to about 10.5 grams/day.


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