Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from vitis
Reexamination Certificate
1998-11-20
2004-11-16
Leith, Patricia (Department: 1654)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from vitis
C424S725000, C424S752000, C424S094100, C424S094200
Reexamination Certificate
active
06818233
ABSTRACT:
BACKGROUND
1. Technical Field
The invention relates to dietary supplements containing natural ingredients.
2. Background Information
Coronary artery disease, myocardial infarction, stroke, and other vascular occlusions are major health concerns. A common characteristic of these diseases is the atherosclerotic process, or the narrowing of arteries. Blood platelets contribute to the development and progression of the atherosclerotic process by releasing growth factors, chemotactic substances and other factors that accelerate the atherosclerotic process. In addition, platelet aggregation at or near the point of arterial damage contributes to the development of atherosclerosis and acute platelet thrombus formation.
Low density lipoprotein (LDL) cholesterol is also associated with atherosclerosis. It has been proposed that nonatherogenic LDL cholesterol circulating in the blood is converted to atherogenic LDL cholesterol through oxidation of polyunsaturated lipids, which leads to modification of the apoprotein.
Physicians use various drugs, such as aspirin, to treat atherosclerotic conditions. Aspirin, however, is not without negative side effects including gastrointestinal irritation. Interventions such as angioplasty are also available to dilate stenosed arteries thereby increasing blood flow. Interventional techniques, however, produce intimal and medial artery damage and expose thrombogenic surfaces. As such, restenosis and the incidence of sudden coronary death following angioplasty is a major concern for patients with known or suspected coronary artery disease.
Given the grave consequences of atherosclerosis and the costs associated with medical treatments, there is a need for pharmacologic and nutritional interventions that are useful for preventing the occurrence and reoccurrence of these conditions.
Epidemiological studies have noted an inverse correlation between the intake of dietary flavonoids from fruits and vegetables and death from coronary artery disease. This correlation is thought to arise from the antioxidant and platelet inhibition properties of flavonoids found in fruits and vegetables.
Certain flavonoids, including those found in grape seed and grape skin extracts, have been associated with the beneficial health effects observed for aspirin, but without the negative side effects attributed to aspirin. Nevertheless, flavonoid bioavailability or activity is low in many sources of flavonoids. As such, certain dietary sources of flavonoids require large doses to be useful. As a result, many sources of flavonoids are impractical, too costly, or both to be useful on a daily basis.
SUMMARY
The present invention involves the discovery that the combination of certain flavonoids and enzymes in the form of a dietary supplement reduces the dosage of supplement needed to effectively reduce platelet activity and LDL cholesterol oxidation in a mammal. The present invention further involves a method to treat conditions associated with platelet activity and LDL cholesterol oxidation by administering combinations of flavonoids and enzymes to reduce platelet activity and LDL cholesterol oxidation.
In one aspect, the invention features a dietary supplement containing at least one flavonoid source and an enzyme wherein the supplement is effective for inhibiting platelet activity and LDL cholesterol oxidation in a mammal at a dosage of about 30 mg/Kg or less. One example of a dietary supplement in accordance with the invention is PROVEXCV™. It is to be understood that a dosage of supplement as used herein refers to the combined weight of the flavonoid source or sources and enzyme. Further, other ingredients such as fillers, lubricants, carriers and the like may be included as additional ingredients.
The flavonoid source or sources in the dietary supplement may be derived from grape seed extracts, grape skin extracts, ginkgo biloba extracts, bilberry extracts or quercetin. The enzymes may include fungal proteases, acid stable proteases, neutral stable proteases, alkaline stable proteases or bromelain.
In another aspect, the invention features a dietary supplement containing at least one flavonoid source wherein the supplement is effective for inhibiting platelet activity and LDL cholesterol oxidation in a mammal at a dosage of about 30 mg/Kg or less. Preferably, a dietary supplement in accordance with this aspect further includes an enzyme that substantially reduces the dosage required to achieve such inhibition.
In another aspect, the invention features a method to inhibit platelet activity or LDL cholesterol oxidation or both in a mammal by administering a dietary supplement containing a flavonoid source and an enzyme wherein the supplement is effective for reducing platelet activity or LDL cholesterol oxidation at a dosage of about 30 mg/Kg or less. The method may also be used to treat a condition that is associated with platelet activity or LDL cholesterol oxidation by administering a dietary supplement containing a flavonoid source and an enzyme that are effective for reducing platelet activity or LDL cholesterol oxidation.
In another aspect, the invention features an article of manufacture containing a dietary supplement that is effective for reducing platelet activity and LDL cholesterol oxidation contained within a packaging material wherein the packaging material is labeled to indicate that the dietary supplement is effective for reducing platelet activity or LDL cholesterol oxidation or both in a mammal at a dosage of about 30 mg/Kg or less. In another embodiment of the article of manufacture, the packaging material may be labeled to indicate that the dietary supplement is useful to treat a condition that is associated with platelet activity or LDL cholesterol oxidation.
Unless otherwise defined, all technical and scientific terms and abbreviations used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. All publications, patent applications, patents and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. Other features and advantages of the invention will be apparent from the following detailed description and from the claims.
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Fish & Richardson P.C. P.A.
Leith Patricia
Melaleuca, Inc.
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