Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2000-08-17
2002-10-08
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
C424S400000, C424S441000, C424S484000, C424S489000, C514S904000, C514S905000, C514S948000
Reexamination Certificate
active
06461634
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a food-based delivery system for providing (a) the required nutritional supplements for stimulating production and release of human growth hormone (HGH) and/or (b) a full range and desired dosages of vitamins and minerals consumed each day by serious takers of such supplements. In more detail, the present invention relates to combinations of amino acids, vitamins, and other nutrients formulated into a convenient and good-tasting food such as a food bar or ready-to-drink beverage that, when ingested orally, stimulates HGH production and/or release for the purpose of producing anti-aging effects. The same food is formulated to provide the full range of the most commonly desired vitamins and minerals consumed by adults who are serious consumers of vitamin and mineral supplements or the vitamins and minerals can be formulated separately for ingestion without the HGH-stimulating amino acids and other nutrients. Either way, the food-based delivery system of the present invention provides a full complement of the vitamins, minerals, and other nutritional supplements in adequate quantity to satisfy most serious consumers of such supplements in a pleasant-tasting form.
With regard to the prior art, it is known to those skilled in the art and to many of the public in general, that HGH levels fall with age starting at about age 35, so that HGH levels are reduced by about two-thirds by the age of 60. It is know that when the HGH levels are restored to more youthful levels, by a schedule of either injections of HGH, or the oral consumption of certain combinations of amino acids, over the ensuing 20 to 180 days, anti-aging effects occur, including: boosting of the immune system, restoration of more youthful vigor and libido, increase of the percentage of lean muscle mass, reduction of the percentage of body fat, increase in the thickness of skin with more youthful texture, increased skin turgor and a decrease of brown “aging” spots.
The beneficial anti-aging effects of increased levels of growth hormone in humans are well documented. See, for instance, R. Klatz, et al., Grow Young with HGH, New York, HarperCollins Publishers, 1997; see also D. Rudman, et al., Effects of Human Growth Hormone in Men Over 60 Years Old; New England Journal of Medicine, 1990; vol 323; 1:1. In the book by Klatz there are numerous references to published and unpublished studies showing the efficacy of orally ingested amino acids in elevating HGH levels and HGH has long been given by injection. The disadvantages of these prior art methods, however, are several: HGH injections are painful and inconvenient, and the cost usually exceeds $10,000 per year. There can be side effects if the injected dosage is too high for the individual. Injections require careful monitoring of blood laboratory tests and careful physician follow-up. If the person is to take the available pill form of HGH-stimulating amino acids, he/she must take eight to sixteen different pills from four to five different bottles one to four times a day. Some of the pills are quite large, and if one is to take all four of the recommended amino acids in correct dosage, one would have to take is pills from as many as four different bottles at each dosage time, for a total of about 16 pills per dose. Further inconvenience is caused by the fact that the pills of the different bottles run out at different intervals, requiring numerous trips to health food stores. In many locales, some of the ingredients are not available for sale in any store. Typical schedules require taking the pills 6 out of 7 days, with breaks of 2 to 6 weeks every 3 to 6 months, and missing any of the recommended dosages or pills can lessen the desired effects.
Because of the inconvenience of numerous bottles of pills of amino acids, there has been the commercial development and sales of powders of the required amino acids, to be mixed with water, or juice, or milk or even swallowed dry. This method is also inconvenient, and some of the powders available are quite unpalatable. It is not convenient to have to mix powders with water while away from home. Also, according to the prior art, it is recommended that either the pills or the powders be consumed on an empty stomach, with no eating to occur for the next 45 minutes. The reason for this recommendation is that it is known in the prior art that significant elevation of blood glucose, which in turn raises blood insulin levels, will suppress production and release of HGH, because higher blood insulin levels lead to higher levels of somatostatin. Somatostatin is a natural hormone produced by the hypothalamus that suppresses HGH release.
Known in the prior art is the fact that the best four amino acids to ingest for the stimulation of HGH release are L-ornithine, L-arginine, L-glutamine and glycine. However, L-lysine may be substituted for L-ornithine, and usually has been, because L-ornithine has a very bad taste. It has been found that 1200 to 1500 mg of L-lysine, together with 1200 to 1500 mg of L-arginine, will suppress somatostatin, which is especially important in those over age 60, because somatostatin is increased in the older age group. Suppressing somatostatin allows more release of HGH. L-glutamine, about 3,000 to 4,000 grams, and glycine, about 1,000 to 2,000 mg, are recommended as stimulants of the natural hypothalamic hormone called GHRH (growth hormone releasing hormone) which in turn stimulates increased HGH production and release. It is also known that 5 mg of melatonin taken one hour prior to vigorous exercise can triple the increase in HGH resulting from vigorous exercise alone. D. Meeking, et al., Exercise-induced GH Secretion is Enhanced by the Oral Ingestion of Melatonin in Healthy Adult Male Subjects; European Journal of Endocrinology; 1999; vol. 141:22-26.
The powders that contain the appropriate amino acids are available in cans and jars that come with scoopers for measuring dosages into a glass to which water or other beverage is to be added. The problems with this prior art are: consuming the powder dry is very difficult, and many of the powders taste bad, even if mixed with water; if mixed with juice or milk, the fructose or lactose of the juice/milk raises blood glucose and insulin levels, which is counter-productive for HGH release as described above. The whole process of opening individual packets, obtaining an empty glass or cup, and obtaining water can be difficult if dose-time occurs when one is away from home, and even more-so during out-of-town trips. The recommendation, for the powdered products known as Rejuvamin and Revamax (Biocentrics), for example, is for one to four doses per day, with two or more doses being preferred. At each dose time, one to one and one-half scoops, or one unitized packet, must be mixed with water or consumed dry.
One object of the present invention, then, is to provide a new method of stimulating production of HGH for delaying, retarding, and/or partially reversing the effects of aging, in the form of a tasty, convenient food bar, other edible food or ready-to-drink beverage. To stimulate HGH production in this manner goes against the teaching of the prior art because it was believed not to be possible to combine the necessary amino acids with any food for the reasons stated above. In the present invention, use is made of the fact that high protein, low carbohydrate diets and food bars have become quite acceptable, even replacing a certain amount of candy bar sales wherein the candy contains sugar. It is known that protein food bars, protein foods in general, and beverages such as protein shakes, diet sodas, etc., do not significantly raise blood glucose levels or insulin levels if the carbohydrate level in such foods is below 3 grams per serving. The delivery system of the present invention therefore combines the preferred amino acid dosages with food or ready-to-drink beverages that taste good and are convenient, as opposed to the prior art of powders and numerous pills.
In recent years, an increasing number of ind
Evans Charesse
Page Thurman K.
Wisner Mark R.
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