Dietary supplement

Details Dietary supplement Dietary supplement

2001-05-15

2002-04-09

Azpuru, Carlos (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Food or edible as carrier for pharmaceutical

C514S168000

Reexamination Certificate

active

06368617

ABSTRACT:

BACKGROUND AND SUMMARY OF THE INVENTION
Human Growth Hormone (hGH), also known as somatotropin, is an endocrine hormone produced by the pituitary. Its production peaks during adolescence and diminishes with age. Upon its release from the pituitary, hGH is converted by the liver and other tissues to its growth-promoting metabolite somatomedin C, commercially known as Insulin-like Growth Factor type 1 (IGF-1), so-called because it performs an insulin-like function of promoting glucose transfer through cell membranes in cell metabolism.
It is now understood that the physiologic effects associated with hGH occur primarily through the function of IGF-1, partly because serum IGF-1 has a half-life of about 20 hours in contrast to circulating Growth Hormone with a half-life of only about 20 minutes. Several factors are known to affect hGH release and IGF-1 response, and they include the hypothalmic hormone somatostatin, which limits hGH release, and Growth Hormone Releasing Hormone (GHRH), which stimulates such release, as well as somatotroph receptors, insulin regulation, hepatic function and the availability of IGF-1 receptors sites. Jamieson, J and Dorman, L. E., The Role Of Somatotroph-Specific Peptides And IGF-1 Intermediates As An Alternative To High Injections, American College for Advancement in Medicine, Oct. 30, 1997. Correlating these factors has led to the development of a proprietary product known as Symbiotropin, available from Jamieson Designs, St. Louis, Mo. Symbiotropin is an hGH secretagogue composed of anterior pituitary peptides, sequenced glycoamino acid complex, pharmaceutical saccharides, L-alpha glycerlphosphoryl choline, a plant-derived source of L-dopa, and botanical regulators of insulin and IGF-1 that has been shown in clinical tests both to promote and modulate IGF-1 levels within a physiologic range, revealing notable improvements in patients undergoing such hormone therapy in terms of muscle size and strength, fat reduction, energy increase, exercise endurance, improvements in skin elasticity, texture, and thickness, and healing capacity.
Another hormone linked to healthy aging, including healthy immune brain and cardiovascular functions, is dehydroepiandrosterone (DHEA), the most abundant hormone in the human body. It is produced by the adrenal cortex along with other steroids such as glucocorticoids (cortisol or hydrocortisone) and mineral corticoids (aldosterone). Concerns have been expressed about its use as a dietary supplement, however, because when it is ingested it is metabolized into various metabolites, some of which may convert into active male or female sex hormones, specifically, testosterone and estrogens.
A natual metabolite of DHEA is 7-keto dehydroepiandosterone (7-keto DHEA), also known chemically as 3-beta-acetoxyandrost-5-en-7,17-dione. 7-keto DHEA is not only a potent metabolite of DHEA but, unlike DHEA, cannot be converted to active androgens and estogens. Scientific research on 7-keto DHEA demonstrates that it has therapeutic applications in immune modulation, immune enhancement through T-cell upregulation, memory enhancement, and weight loss and management by means of its theromagenic-enhancing action. For further information on 7-keto DHEA, reference may be made to U.S. Pat. Nos. 5,290,730, 5,296,481, 5,585,371, and 5,641,766, the disclosures of which are incorporated by reference herein.
SUMMARY OF THE INVENTION
It is an object of the invention to provide new orally-ingestable dietary supplements that reduce or retard the effects of aging. More specifically, the invention is concerned with dietary supplements that replenish or stimulate the production and release of hormones that promote longevity, enhance wellness, and reduce the effects of aging at the cellular level.
Along with other ingredients, the food supplements of this invention comprise both 7-keto DHEA and a secretagogue for pituitary somatotrophs that contains anterior pituitary peptides, a sequenced glycoamino acid complex, a source of L-dopa, pharmaceutical saccharides, botanical regulators of insulin and IGF-1, and L-alpha glycerylphosphoryl choline (GPC). The supplements may also contain antioxidants and natural herbal ingredients that are believed to reduce damage at the cellular level caused by free radicals and which are believed to be active in reducing memory loss, promoting healthy brain function, and eliminating harmful toxins.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The secretagogue known as Symbiotropin (from Jamieson Designs, St. Louis, Mo.) has been found to promote hGH production by the pituitary and the release of IGF-1 in physiologic ranges, and generally to reverse many of the symptoms of human biological aging, by restoring muscle mass, decreasing body fat, thickening the skin and reducing wrinkles, increasing energy and sexual function, restoring the size of liver, pancreas, heart and other organs that shrink with age, improving vision and memory, elevating mood and improving sleep, normalizing blood pressure, increasing cardiac output and stamina, improving immune function, and assisting in wound healing. The secretagogue is known to comprise a combination of anterior pituitary peptides, a glycoamino acid complex, pharmaceutical saccharides, a plant-derived source of L-dopa, botanical regulators of insulin and IGF-1, and L-alpha glycerylphosphoryl choline (alpha GPC). By also including 7-keto DHEA, the dietary supplements of the present invention may provide further and significant anti-aging enhancements or improvements as compared to supplements and methods employing only the secretagogue. Although the present invention is not to be limited by any theoretical explanation, it is believed that a coaction exists between the glycoamino acid complex of the secretagogue and 7-keto DHEA. Such glycoamino acid complex consists of L-glutamine, L-arginine pyroglutamate, L-lysine monohydrochloride, glycine, and gamma aminobutyric acid. The combination of those amino acids with 7-keto DHEA is believed to bring the hypothalamus, pituitary, and adrenal axis into balance. This is accomplished by an interaction of 7-keto DHEA and the glycoamino acid complex resulting in the ability to down-regulate cortisol levels, which play an antagonistic role in the ability of receptor sites to be used, and helping to normalize insulin levels. With cortisol and insulin levels in the appropriate balance, the combination is believed to re-sensitize receptor sites on each of these three organs, as well as at the cellular level. When the cellular and organ receptor sites are at maximum sensitivity, they operate more efficiently, thereby allowing the rest of the ingredients of the dietary supplement to be more effective.
7-keto DHEA, whose scientific name is 3-beta-acetoxyandrost-5-en-7,17-dione, is a naturally-produced metabolite of DHEA, and scientists have postulated that it is the metabolites of DHEA that are the true active ingredients since no specific receptors in the body have been identified for DHEA itself. Researchers have since discovered that such hypothesis is correct and, more specifically, that in hormone therapy 7-keto DHEA significantly outperforms DHEA in areas such as immune modulation, memory enhancement, and thermogenesis for weight management, all without the unwanted side effects associated with DHEA. Reference may be had to the aforementioned patents for further information on 7-keto DHEA, identified generally under the designation “androstenes” in such patents. 7-keto DHEA is well known and commercially available, one such source being Humanetics Corporation, Chanhassen, Minn.
The dietary supplement compositions of this invention may be provided in liquid or powder form, with powders suitable for mixing with water or other liquids, and for ingestion as a beverage, being preferred. The amount of such powder needed for a recommended daily serving depends, of course, on the extent to which additional ingredients are included, and in that regard, the supplement of this invention is preferably formulated to include a complex of ingredients that d

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