Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from leguminosae
Reexamination Certificate
2002-02-22
2002-12-03
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from leguminosae
C424S489000, C426S615000, C426S648000
Reexamination Certificate
active
06488968
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to nutritional supplements. More particularly, the invention relates to a nutritional supplement composition, and methods of use thereof, to enhance the bioavailability of isoflavone.
Nearly 70 years ago, it was reported that certain plants could induce estrus in animals. Subsequently, over 300 plants have been found to possess estrogenic activity (see e.g., Bradbury and White, Vitamin Horm. 12:207 (1954), and Farnsworth et al., J. Pharm. Sci. 64:717(1954)). These compounds have been given the general name of “phytoestrogens” and represent several chemical classes of diphenolic plant compounds that are somewhat related structurally to the mammalian sex hormone 17-beta-estradiol. See Setchell, K. D. R., et al Am. J. Clin. Nutr., 40:569 to 578 (1984). Similarities in the molecular structure of phytoestrogens facilitate binding to the estrogen receptor. An important class of the phytoestrogens is the isoflavone class. Two chemical classes of phytoestrogens are abundant in soybeans, total soy products, and soy protein isolates. Those two classes are coumestrol and isoflavones. The latter class includes daidzein, genistein, glycitein, as well as their glycoside and acetylated forms.
Phytoestrogens and their metabolites interact with specific cell receptors and compete with endogenous hormone molecules [see Folman, Y. et al, J. Endocr., 44:213 to 218 (1969)], but the biological estrogen-like effect of these compounds is relatively weak. See Kaziro, R. et al, J. Endocr., 103:395 to 399 (1984) and Tang, B. Y. et al, J. Endocr. 85:291 to 297 (1980). Phytoestrogens can induce two different effects in an organism. When the level of endogenous sex hormones is relatively high, the antiestrogenic effect prevails. There are several mechanisms of antiestrogenic activity of the phytoestrogens, including feedback inhibition at the hypothalamus and pituitary gland, and competition and blockade of cell receptors. It has been observed that a phytoestrogen and lignan-rich diet is associated with a reduction in free plasma estradiol, and in reduction of the risk of breast cancer. See Adlercreutz, H. et al, J. Steroid. Biochem., 27:1135 to 1144 (1987) and Mousavi, Y. et al, Steroids, 58:301 to 304 (1993). On the other hand, in postmenopausal women, phytoestrogens can provoke an estrogenic response. See Adlercruetz, H. et al, Lancet, 339:1233 (1992). This dual effect of weak estrogens is demonstrated, and well known “partial” antigens such as Tamoxifen have these properties.
Phytoestrogens have been demonstrated in clinical trials to modulate the menstrual cycle, reduce menopausal symptoms, and lower LDL cholesterol levels. J. Nutr., 1996, 126(1): 161-7; N. Engl. J. Med., 1995, 333: 276-82. Epidemiologic observations indicate women in countries where diets are rich in phytoestrogens (averaging about 40-50 mg/day) have a decreased incidence of breast cancer, menopausal symptoms and osteoporosis. Nutr. Cancer, 1994, 21:113-131; J. Nutr., 1995, 125; 757S-770S; Am. J. Clin. Nutr. 1995, 62:645. Animal studies have provided a biological basis for these observations. J. Ster. Biochem & Mol. Bio., 1992, 41(3-8): 331-7; First International Symposium on the role of Soy and Preventing and Treating Chronic Disease (1994), Speaker Abstracts.
Soybeans are a particularly important source of phytoestrogens. Several hundred varieties or cultivars of soybeans exist, and their phytoestrogen content can vary from 50 mg/100 g to 300 mg/100 g. In addition, given the high levels of consumption of soy protein by certain Oriental cultures, there is a substantial body of relevant epidemiologic evidence. For example, there is epidemiologic evidence that phytoestrogens are associated with a lower risk of development of breast and uterine cancer. Experimental evidence for lower breast cancer incidence associated with dietary intake of phytoestrogens in soybeans has also been reported (Barnes et al., In Jacobs M M, ed., Diet and Cancer: Markers, prevention and treatment, New York: Plenum Press, 135 (1994)). Specifically, dietary soy protein preparations enriched with phytoestrogens inhibited mammary tumors in rats treated with 7,12-dimethyl-benz[a]anthracene compared to rats fed low-phytoestrogen soy protein preparations.
The increasingly frequent suggestion that phytoestrogens may protect against development of coronary artery atherosclerosis (CAA) and coronary heart disease (CHD) is based on the evidence that endogenous estrogen protects premenopausal women from CHD relative to men of the same age, that loss of ovarian hormones accounts for the increase in CHD in postmenopausal women, and that estrogen replacement decreases CHD risk among postmenopausal women.
In addition to the epidemiological evidence, recent experimental observations have suggested that phytoestrogens may protect against the development of CAA. For example, studies have shown that male casein-fed rats had significantly higher total plasma cholesterol (TPC) and low density lipoprotein cholesterol (LDL-C) concentrations than soy protein-fed rats. When soybean phytoestrogens were added to casein, the animals had LDL-C concentrations similar to the soy protein-fed-group.
It has been recently recognized that the isoflavones contained in vegetable proteins, such as soybeans, may inhibit the growth of human cancer cells, such as breast cancer cells and prostrate cancer cells, and is described in the following articles: “Genistein Inhibition of the Growth of Human Breast Cancer Cells; “Independence from Estrogen Receptors and the Multi-Drug Resistance Gene” by Peterson and Barnes Biochemical and Biophysical Research, Communications; Vol. 179, No. 1, pp. 661-667, Aug. 30, 1992; “Genistein and Biochanin A Inhibit the Growth of Human Prostate Cancer Cells but not Epidermal Growth Factor Receptor Tyrosine Auto-phosphorylation” by Peterson and Barnes: The Prostate 22: pp. 335-345 (1993) and “Soybeans Inhibit Mammary Tumors in Models of Breast Cancer” by Barnes, et al. Mutagens and Carcinogens in the Diet; p. 239-253 (1990).
Isoflavones have been added to nutritional supplements for a variety of therapeutic purposes as shown in U.S. Pat. Nos. 5,523,087; 5,424,331; 5,516,528; and 5,807,586. The bioavailability in human subjects of dietary isoflavones is of great importance relative to their biofunctional effects. Once ingested, several factors influence the bioavailability of isoflavones. Simply adding phytoestrogen-rich foods to the diet may not ensure effective bioavailability because isoflavones cannot work unless they are first converted to biologically active estrogen-like compounds by friendly intestinal bacteria. Since the presence of friendly bacteria is, in turn, dependent upon a healthy gastrointestinal climate, all the dietary and lifestyle factors that affect the digestive tract can have significant impact on the bioavailability of dietary isoflavones.
In view of the foregoing, there is a need for a composition for the enhancement of isoflavone bioavailability in human beings and other warm blooded animals that improves digestive tract environment.
BRIEF SUMMARY OF THE INVENTION
The present invention provides a composition and a method for improving the gastrointestinal climate for beneficial microorganism growth in warm blooded animals.
The present invention also provides a composition and a method for improving isoflavone metabolism and the bioavailability of phytoestrogens in warm blooded animals.
One embodiment of the present invention is a dietary supplement composition for administration to warm blooded animals comprising a fiber, L-glutamine and a phytoestrogen.
Another embodiment of the present invention is a method for improving the gastrointestinal climate for friendly bacterial growth and the bioavailability of phytoestrogen comprising the steps of administering effective amounts of a composition comprising fiber, L-glutamine and a phytoestrogen.
DETAILED DESCRIPTION
Before the present composition and methods of making and using thereof are disclosed and described, it is to be und
Hsu Charles C.
Hu Qing-Fu
Paul Stephen M.
See Melissa
Shu Daniel
Sun Ten Laboratories, Inc.
Thorpe North & Western, LLP.
Winston Randall
LandOfFree
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