Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Aluminum – calcium or magnesium element – or compound containing
Reexamination Certificate
1999-07-30
2002-08-20
Dees, Jose′ G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Aluminum, calcium or magnesium element, or compound containing
C424S725000, C424S757000, C424S764000, C424S773000, C424S776000, C426S072000, C426S073000, C426S074000, C426S590000, C426S654000, C426S655000, C426S658000, C514S054000, C514S060000, C514S061000, C514S167000, C514S460000, C514S553000, C514S557000, C514S682000, C514S772000, C514S777000, C514S782000, C514S783000, C514S904000, C514S905000, C514S970000
Reexamination Certificate
active
06436446
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to nutritional supplements and more particularly to a composition and method for reducing the risks associated with bone density loss, e.g., the risks of osteoporosis.
2. Description of Related Art
Osteoporosis is a debilitating disease affecting as many as one in three women after menopause. The disease affects the skeletal structure making the skeletal structure weak and frail. Calcium and magnesium supplementation is seen as one way to protect against osteoporosis. Men also experience a loss in bone density with age. Accordingly, health care practitioners increasingly encourage calcium and magnesium supplementation for men and women of all ages.
In general, only about 30 percent of dietary calcium is absorbed by the body and deposited in the bone. Improved calcium (and magnesium) absorption in the body would have important consequences in the reduction of osteoporosis and bone fractures.
Several calcium and/or magnesium supplements have been introduced in recent years. U.S. Pat. No. 5,389,387 issued to Zuniga, et al. and U.S. Pat. No. 5,401,524 issued to Burkes, et al. describe a calcium beverage supplement composition. These compositions combine malic acid and citric acid with a calcium syrup such as calcium lactate. The malic acid and citric acid provide stability against precipitation of the calcium salt, as well as taste and mouth feel quality. U.S. Pat. No. 5,424,321 issued to Shlyankevich and U.S. Pat. No. 5,654,011 issued to Jackson, et al. describe beverage compositions including calcium, Vitamin D, magnesium, and zinc.
Soy isoflavones are another group of dietary acceptable compounds believed to be beneficial in the treatment and/or prevention of osteoporosis. U.S. Pat. No. 5,424,321 describes a composition for the treatment or prevention of osteoporosis that utilizes soy bean food products that contain natural phytoestrogens of the isoflavone or coumestan groups. The isoflavones include daidzein, genistein, and glycitein. The classes of isoflavones can also be derived synthetically. The patent claims that the soy isoflavones are effective in preventing osteoporosis by provoking an estrogenic response in post-menopausal women.
In general, it is believed that the majority of calcium and magnesium absorption occurs in the intestines. Certain oligosaccharides, including inulin, are believed to stimulate mineral absorption in humans. Oligosaccharides are also believed to increase the bifidobacteria population in the large intestine including the colon, contributing to beneficial effects in humans, including a reduction of harmful bacteria, toxic metabolites, and detrimental enzymes.
What is needed is a composition that improves the calcium and magnesium absorption in humans to increase bone density and reduce the risk of osteoporosis.
SUMMARY OF THE INVENTION
An improved supplement composition and a method of reducing bone density loss is disclosed. In one aspect, a composition suitable for human consumption combines a dietary acceptable amount of a calcium compound, a dietary acceptable amount of a magnesium compound, at least one soy isoflavone, inulin, and a dietary acceptable amount of Vitamin D
3
. Other components, include but are not limited to, minerals such as phosphorus and zinc; vitamins including Vitamin C (ascorbic acid) and Vitamin K; stabilizing agents; acidifiers; and sweeteners.
The composition of the invention may be in the form of a ready to drink beverage, a beverage preparation of a dry mix or syrup concentrate, a wafer, a paste, or a bar. The composition may also contain a variety of levels of the individual components. For example, a desired daily amount of the individual components of the composition has been determined. This amount may be administered as a single dose or as several doses. Where the composition is a beverage, for example, the beverage may constitute, for example, one-eighth of a predetermined daily amount of the individual components, making the beverage suitable for consumption eight times daily as in the recommended daily amount of water intake.
In a beverage form, the invention maximizes the solubility of soy isoflavones in solution by, in one embodiment, including a stabilizing agent of at least one of maltol, a composition of carrageenan and maltodextrin, or xanthan gum. The beverage composition may be a clear or a colored solution without significant residue or sediment. The beverage is also, preferably, adjusted to a pH between 3 and 7 and more preferably between pH 4 and 5 at room temperature with an organic acid in an amount up to the equivalent amount of a calcium of the calcium compound.
As a method of reducing the risk of bone density loss, the invention contemplates the step of administering a composition suitable for human consumption comprising a portion of the daily predetermined amount of a calcium compound, a magnesium compound, an isoflavone, inulin, phosphorus, Vitamin D
3
, Vitamin K, a zinc compound, and ascorbic acid. The composition may be administered in various forms, including as a beverage, a paste, or a bar. The amount of the individual components of the composition may be adjusted to provide a portion, including the entire portion, of a predetermined beneficial amount, such as a predetermined daily amount.
DETAILED DESCRIPTION OF THE INVENTION
The invention relates to a composition that includes a supplement to provide the dietary needs of individuals for nutrients to support adequate bone density and a healthy skeletal system. The composition also provides appropriate nutrients to reduce the risk of osteoporosis or to treat bone density loss associated with osteoporosis. The invention also relates to a method of reducing the risk of bone density loss commonly associated with the development or onset of osteoporosis.
In one embodiment, the composition of the invention comprises active ingredients of inulin, isoflavones such as soy isoflavones, minerals, and optionally one or more vitamins. More particularly, the composition includes, in one embodiment, a dietary acceptable amount of a calcium compound and a magnesium compound, together with a soy isoflavone, inulin, and a dietary acceptable amount of Vitamin D
3
.
Calcium and magnesium are important in supporting a healthy skeleton system, by building bone mass. There are a variety of calcium and magnesium salts that are suitable for human consumption and are suitable for contributing to bone growth according to the invention. Suitable calcium salts include, but are not limited to, calcium lactate and calcium gluconate. Suitable magnesium salts include, but are not limited to, magnesium glycerophosphate and magnesium sulfate. Magnesium glycerophosphate is a desired choice of the magnesium salt because magnesium glycerophosphate also contributes a phosphorous component to the composition. Phosphorous is believed to contribute to bone density and a healthy skeletal system.
Isoflavones are a dietary source for increasing bone density. The isoflavones suitable for the invention include, but are not limited to, the naturally occurring soy isoflavones from soy including the classes such as daidzein, genistein, and glycitein in a variety of forms (e.g., glycosidic and acetylated forms). Soy isoflavones are commercially available, for example, from Archer Daniels Midland of Decatur, Ill. Synthetically derived isoflavones may also be suitable.
Oligasaccharides include, but are not limited to, fructo-oligosaccharides and gluco-oligosaccharides. Inulin, a fructo-oligosaccharide is derived principally from chickory root. Oligosaccharides such as inulin provide at least two benefits. First, oligosaccharides increase the intestinal absorption of minerals, such as calcium and magnesium. Second, oligosaccharides improve the intestinal microflora by increasing the amount of colonic bifidobacteria. Inulin as an oligosaccharide source is commercially available, for example, from Imperial Suiker Unier of Sugar Land, Tex.
Vitamin D
3
stimulates intestinal absorption of minerals, particularly c
Forusz Samuel L.
Liu Hanlan
Muatine Rose M.
Blakely , Sokoloff, Taylor & Zafman LLP
Choi Frank
Dees Jose′ G.
Pharmavite LLC
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