Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined... – Milk or colostrum
Reexamination Certificate
2002-09-23
2003-12-23
Tate, Christopher R. (Department: 1654)
Drug, bio-affecting and body treating compositions
Extract, body fluid, or cellular material of undetermined...
Milk or colostrum
C424S702000, C424S400000, C424S442000
Reexamination Certificate
active
06667063
ABSTRACT:
FIELD OF THE INVENTION
The present invention provides novel therapeutic nutritive compositions useful for increasing glutathione production in mammals, including humans, thereby to enhance the mammalian response to infection, stress or other trauma. More specifically, the invention provides novel food supplement compositions containing as the essential ingredients colostrum, a selected whey product and defined amounts of selenium or an organic or inorganic, water soluble selenium precursor.
BACKGROUND OF INVENTION
There are at the present time hundreds, perhaps thousands of food supplement compositions. Most of these compositions are designed to enhance the nutritional value of the food consumed by mammals including humans and animals, to increase energy levels, or to maintain electrolyte balance. These food supplements often comprise mixtures which if administered orally or parenterally are intended to bring to desired values the amount of vitamins, minerals, amino acids, salts and other materials required for proper nutrition in mammals. They are particularly valuable as sources of essential amino acids which may or may not be in foods but, in any event are destroyed or not synthesized by the metabolic processes of the mammalian body. Eight such amino acids are known. These include for example, leucine, isoleucine and phenylalanine.
The compositions may also contain small amounts of iron, zinc, calcium and other metals, non-metals and other ingredients thought to be necessary for proper nutrition. Some such supplements may contain as many as twenty different ingredients including natural and artificial flavoring agents, natural and artificial colors, binders, fillers and similar materials normally employed as excipients in such compositions.
Glutathione is a tripeptide and a major reducing agent in the mammalian body. Its chemical structure is:
or, more simply
GLU-CYS-GLY
Its chemical name is &agr;-glutamyl-cysteinyl-glycine.
Like many other small peptides in the mammalian body, it is not synthesized by procedures involving DNA, RNA and ribosomes. Rather, it is synthesized from the amino acids available in the body by procedures utilizing enzymes and other body components such as adenosine triphosphate as an energy source.
Glutathione performs many functions in the mammalian body. One of its principal functions is as an antioxidant to reduce hydrogen peroxide and other oxidants thereby minimizing their deleterious effects. Another is to scavange free radicals. It has several other well substantiated detoxification activities.
The reduction of hydrogen peroxide is shown by the following simplified reaction sequence in which G represents glutathione, SH is the sulfhydryl group of the cysteine moiety and NAHD is an energy source:
As will be seen, glutathione is regenerated after reducing hydrogen peroxide to water.
One of the most important contributions of glutathione to mammalian health is its participation in the proper functioning of the immune system to respond to infection or other types of trauma including, for example, chemotherapy, radiation therapy, stress and HIV infection. It is known that weakening of the immune system caused by these or other traumas occurs concurrently with depletion of glutathione in body tissues. It is known, also, that such weakening can be reversed by replenishing the supply of glutathione. It is believed that glutathione accomplishes its salutary effects by protecting immune cells against the ravages of oxidizing agents and free radicals.
There is some question as to whether orally ingested glutathione is available to enhance the immune system. Since it is a tripeptide, conventional wisdom suggests that it would be hydrolyzed in the intestinal system to release the free amino acids. Some experts are of the opinion that glutathione resists hydrolysis when taken orally. Even if some of this peptide gets through the gastrointestinal wall intact, it is questionable whether it can be absorbed as such into the individual cell rather than being synthesized intracellularly. In any event, it is generally acknowledged that an increase in tissue concentrations of glutathione facilitates resistance to invasion by infective agents by enhancing the immune system.
Whey is the curd-free portion of milk that remains after the production of cheese. “Whey” is a term referring to the serum or watery part of milk after removal of the cheese. Removal of a substantial portion of the water results in a dry whey. There are two types of dry whey. These are dry whey concentrates and dry whey isolates. The former (WPC) is an off-white to cream colored product which, depending on the method of manufacture, may contain from about 15% to 85% protein based on the total weight. It may additionally contain small amounts of minerals, vitamins and carbohydrates.
Whey protein isolate (WPI) contains more than 85% by weight of protein.
Both types of whey are available from Proliant, Manhattan, Ill.; Davisco Foods International, Inc. Eden Prairie, Minn. or Land-O-Lakes, Tulare, Calif.
A more important classification of whey for the understanding of this invention is that the whey is either denatured or undenatured.
Denatured whey which may be either WPC or WPI is whey in which the globular structure of the constituent protein has been disrupted into a random coil formation or has been partially hydrolyzed. Such disruption may be caused by heat, pumping, mixing, aeration, vacuum evaporation, drying or other processing operations. Undenatured whey is prepared under carefully controlled conditions so that the protein structure is substantially the same as in the milk from which it was obtained.
Whey products exist commercially or are otherwise known which are substantially undenatured or in which the whey has undergone various degrees of denaturization. The immune regulating or chemical activities of these products generally vary with the degree of denaturation.
Sometimes a specific activity is eliminated by any degree of denaturation. For example, as will be explained in more detail below, undenatured and denatured WPC or WPI have substantially the same nutritional value in mammals, but denaturization abolishes the ability of the products to modulate immunological activity.
The cost of undenatured whey tends to decrease directly with the degree of denaturation. Whey products in which the degree of denaturation is less than 10-15 percent are too expensive for use in products intended for general use by humans or in animal feeds. Although undenatured whey is known to enhance immunological activity, the art has long been seeking whey products and compositions which retain immunological modulating activity without being prohibitively expensive.
Colostrum is a thin milky fluid secreted by the mammary gland of mammals a few days before or after parturition. It is a unique combination of beneficial nutrients including protective antibodies, fat, carbohydrate, vitamins and minerals.
The immunological components of colostrum include IgG, IgM and IgA. These components confer passive immunity to the neonate and protection against infection during the initial period after parturition. After this period, colostrum is no longer absorbed through the gut and the newborn must depend upon its own developing immune system for protection.
Colostrum is an important factor in the growth of mammals including humans, bovines, caprines, porcines and equines. The preferred colostrums for use in the compositions of this invention are bovine and caprine. Several colostrum products useful in the practice of this invention are commercially available.
The compositions of this invention are often employed together with soluble dietary fibers such as inulin and fructo-oligosaccharides (FOS), although the use of these materials is optional. They may be mixed into the same dosage unit as the novel compositions of the invention or separately administered, usually concurrently. When inulin or FOS are utilized, the beneficial bifidobacteria increase significantly in the intestine and the concentration of pathogenic
Klauber & Jackson
Tate Christopher R.
Winston Randall
LandOfFree
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