Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined... – Cardiovascular system – other than umbilical artery or vein
Reexamination Certificate
1998-03-20
2001-03-20
Leary, Louise N. (Department: 1623)
Drug, bio-affecting and body treating compositions
Extract, body fluid, or cellular material of undetermined...
Cardiovascular system, other than umbilical artery or vein
C544S261000, C549S403000
Reexamination Certificate
active
06203818
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a nutritional supplement composition, more particularly, to a nutritional supplement composition that is intended to benefit cardiovascular health via aiding in preventing, delaying the onset of and/or slowing the progression of atherosclerosis and coronary heart disease (CHD), and to a method for aiding in preventing, delaying the onset of and/or slowing the progression of atherosclerosis and CHD by administration of the nutritional supplement composition to an individual.
According to the 1996 American Heart Association statistical summary, 42% of all deaths in America are from some form of cardiovascular disease. Since cardiovascular disease is the leading cause of death in the United States and many other developed countries, it is not surprising that heart specialists and physicians in general arc frequently asked to provide advice concerning nutritional factors that may aid in preventing, delaying the onset of and/or slowing the progression of atherosclerosis and CHD.
The use of vitamin and mineral supplements in one's diet is well established. Specifically, vitamin and mineral supplements heretofore devised and used for the purpose of providing daily nutrients are known to consist basically of familiar, predictable and obvious combinations. While many of the known supplements are adequate to fulfil their objectives, few have been specifically composed for improving cardiovascular health via aiding in preventing, delaying the onset of and/or slowing the progression of atherosclerosis and coronary heart disease.
A number of synthetic drug formulations are available to maintain and benefit cardiovascular health or to treat or prevent atherosclerosis and coronary heart disease. Clofibrate, Gemfibrozil, Questran, Colestipol and HMG CoA reductase inhibitors arc a few examples of synthetic drugs prescribed for decreasing cholesterol and triglyceride levels. All of the above-mentioned drugs have significant potential for side effects which include nausea, hepatic dysfunction, bone marrow suppression, gastrointestinal discomfort, heartburn, diarrhea, constipation, etc.
Aspirin is known to decrease platelet aggregation, reduce the incidence of transient ischemic attacks, ameliorate a myocardial infarction, and has been used as a prophylactic agent for these purposes. Aspirin, however, is known to have a variety of undesirable side effects. For example, aspirin can contribute to formation of gastric ulcers. At higher doses, patients may experience tinnitus, decreased hearing and vertigo. In addition, patients with hemophilia are particularly susceptible to serious side effects of aspirin.
Given the above problems, there remains a need for a nutritional supplement that contains naturally occurring ingredients which can by design provide specific nutritional elements that available studies have shown provide potential benefit in preventing, delaying the onset of and/or slowing the progression of atherosclerosis and coronary heart disease. The nutritional supplement of the invention is also expected to provide these benefits without anticipation of untoward side effects.
SUMMARY OF THE INVENTION
The present invention provides a nutritional supplement composition comprising one or more flavonoids and folic acid or folate (i.e., salts or esters of folic acid). More particularly it provides a nutritional supplement formulation containing a prophylactically effective amount of one or more flavonoids and folic acid or folate which is specifically dedicated to aiding in preventing, delaying the onset of and/or slowing the progression of atherosclerosis and CHD. A particularly preferred nutritional supplement composition comprises quercetin and folic acid or folate.
The present invention also provides a method for aiding in preventing, delaying the onset of and/or slowing the progression of atherosclerosis and CHD which comprises the step of administering the nutritional supplement composition to an individual who is at risk or may be at risk of atherosclerosis and coronary heart disease.
REFERENCES:
patent: 3689663 (1972-09-01), Krämer et al.
patent: 3903266 (1975-09-01), Robbins
patent: 4842859 (1989-06-01), Liu
patent: 4940658 (1990-07-01), Allen et al.
patent: 5043323 (1991-08-01), Bombardelli et al.
patent: 5108750 (1992-04-01), Liu
patent: 5215750 (1993-06-01), Keane, II
patent: 5364644 (1994-11-01), Walaszek et al.
patent: 5514382 (1996-05-01), Sultenfuss
patent: 5563126 (1996-10-01), Allen et al.
patent: WO91/11117 (1991-08-01), None
patent: WO96/13179 (1996-05-01), None
White et al; “Principles of Biochemistry”, 6th edition; p. 419, 1978.*
L.J. Machlin: “Handbook of Vitamins; second edition” 1990, Marcel Dekker, New York SP002082605, pp. 477,478,482,572-575.
International Search Report dated Nov. 12, 1998.
Sue Rodwell Williams, Nutrition and deit therapy,The C. V. Mosby Company, 1969, pp. 111-116.
R. Gugler et al., Disposition of Quercetin in Man after Single Oral and Intravenous Doses*,Europ. J. clin. Pharamacol.9, 229-234 (1975).
Joachim Kühnau, The Flavonoids. A Clas of Semi-Essential Food Components: Their Role in Human Nutrition,Wld Rev. Nutr. Diet., vol. 24, pp. 117-191 (Karger, Basel 1976).
Umeo Takahama, Inhibition of Lipoxygenase-Dependent Lipid Peroxidation by Queretin: Mechanism of Antioxidative Function,Phytochemistry, vol. 24, No. 7, pp. 1443-1446, 1985.
W.S. Pierpoint, Flavonoids in the Human Diet,Plant Flavonoids in Biology and Medicine: Biochemical, Pharmacological, and Structure-Activity Relationships, pp. 125-140, Alan R. Liss, Inc. 1986.
Jadwiga Robak et al., Flavonoids are Scavengers of Superoxide Anions,Biochemical Pharmacology, vol. 37, No. 5, pp. 837-841, 1988.
Roger R. Williams et al., Hyperhomocyst(e)inemia in Utah siblings with early coronary disease,Coronary Artery Disease, 1990, 1:681-685.
Jacques J. Genest, Jr. et al., Plasma Homocyst(e)ine Levels in Men With Premture Coronary Artery Disease,JACC, vol. 16, No. 5, Nov. 1, 1990, pp. 1114-1119.
Lars Brattström et al., Impaired homocysteine metabolism in erly-onset cerebral and peripheral occlusive arterial disease,Atherosclerosis, 81 (1990) 51-60.
Catherine V. deWhalley et al., Flavonoids Inhibit the Oxidative Modification of Low Density Lipoproteins by Macrophages,Biochemical Pharmacology, vol. 39, No. 11, pp. 1743-1750, 1990.
Nobuyuki Ito, Is Quercetin Carcinogenic?,Jpn. J. Cancer Res., 83, 312-314, Mar. 1992.
Dunnick JK et al., Toxicity and carcinogenicity studies of quercetin, a natural component of foods,Fundamental&Applied Toxicology19(3) :423-31, Oct. 1992.
Gaspar J. Laires A. et al., Quercetin and the mutagenicity of wines,Mutagenesis8 (1) :51-5, Jan. 1993.
E.N. Frankel, Inhibition of oxidation of human low-density lipoprotein by phenolic substances in red wine,The Lancet, vol. 341: Feb. 20, 1993, pp. 454-457.
Michaël G.L. Hertog et al., Dietary antioxidant flavonoids and risk of coronary heart disease: the Zutphen Elderly Study,The Lancet, vol. 342, Oct. 23, 1993, pp. 1007-1011.
Laires A. Gaspar et al., Genotoxicity of nitrosated red wine and of the nitrosatable phenolic compounds present in wine: tyramine, quercetin and malvidine-3-glucoside,Food&Chemical Toxicology, 31(12) :989-94, Dec. 1993.
Michaël G.L. Hertog, Content of Potentially Anticarcinogenic Flavonoids of Tea Infusions, Wines, and Fruit Juices,J. Agric. Food Chem., 1993, 41, 1242-1246.
L. Daly et al., Hyperhomocysteinaemia: a metabolic risk factor for coronary heart disease determined by both genetic and environmental influences?,Quarterly Journal of Medicine, 1993; 86:685-689.
Brief Critical Reviews, Dietary Flavonoids and Risk of Coronary Heart Disease,Nutrition Reviews, vol. 52, No. 2, Feb. 1994: 59-68.
Petra Verhoef et al., A Prospective Study of Plasma Homocyst(e)ine and Risk of Ischemic Stroke,Stroke, vol. 25, No. 10, Oct. 1994, pp. 1924-1930.
Brief Critical Reviews, Vitamin Nutrition Stqatus and Homocysteine: An Atherogenic Risk Factor,Nutrition Reviews, vol. 52, No. 11, Nov. 1994: 383-393.
Palgan, K. et al., [Flavonoids in medicine]. &lsqb
Coventry Group, Ltd.
Leary Louise N.
Thompson Hine & Flory LLP
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