Method of decreasing cholesterol and triglycerides levels...

Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined... – Separated animal oil or solidified form thereof derived from...

Reexamination Certificate

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C435S091500, C435S091500, C435S091500, C435S091500, C426S073000, C426S599000, C426S601000, C426S602000, C426S648000

Reexamination Certificate

active

06326031

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention provides a novel composition for preventing cardiovascular diseases in the human system, and more specifically to nutritive compositions containing fish oil, garlic, rutin, and capsaicin that reduce the levels of triglycerides, cholesterol, and low density lipoprotein (LDL) in the human blood serum, and increase the levels of high density lipoprotein (HDL) in human blood serum.
2. Background of the Invention
In the few years, scientific literature has provided strong evidence for a bona fide link between micronutrient compositions (such as vitamins, minerals, fish oils, and plant extracts) and cardiovascular disease. For humans of high risk for cardiovascular diseases, realizing an appreciable reduction in the levels of high cholesterol, triglycerides, low density lipoprotein (LDL) in their blood serum is known to be important for reducing the risk of cardiac diseases. It is also known that effecting an increase in the levels of high density lipoprotein (HDL) also provides a significant decrease to the risk of cardiac diseases.
Cardiovascular disease resulting from the buildup of arterial plaque is known to be a leading cause of illness and death in humans. Arterial plaque is caused by precipitous material formed chiefly of oxidized low density lipoprotein (O-LDL). The buildup of plaque in the form of O-LDL in the arteries is understood to be a factor in ischemic heart disease. Free radical oxidants, many of which come from naturally occurring sources such as sun exposure, metabolism of certain nutrients, exercise, or are otherwise often observed in persons suffering from diabetes and high blood pressure, act to oxidize LDL into its deleterious form, O-LDL. Free radical “scavengers” such as vitamins A, E, C, and selenium are believed to react with these oxidants and render them incapable of oxidation. The inhibitory action of these antioxidants thus inhibits the formation of O-LDL, thereby lowering the levels of arterial plaque deposits in blood vessels. In contrast, the presence of high density lipoprotein (HDL) in the body is understood to have beneficial health effects. Specifically, HDL is known to be more soluble form of lipoprotein, hence its presence does not significantly contribute to the formation of arterial plaque. In addition, it is known that HDL is able to absorb plaque material and may thus directly reduce the amount of arterial plaque.
3. Description of Prior Art
Essential fatty acids (EFAs) are naturally occurring unsaturated fatty acids with a chain length of 18, 20, or 22 carbon atoms. These EFAs cannot be synthesized by the body, hence, dietary intake of EFAs is required. Two fatty acids which fall within the family of EFAs are eicosapantaenoic acid (EPA) and docosahexaenoic acid (DHA), both of which are commonly found in fish oils. Epidemiological observations indicate that fish oils reduce platelet aggregation and serum triglycerides which may reduce the risk of myocardial infarction, hypertension, antherosclerosis, and certain types of cancer. [Gerster, H.,
Internat. J. Vit. Nutr. Res.,
65:3-20 (1994)]. Specifically, it has been shown that EPA and DHA derived from fish oils play important structural roles in membranes of most cells, and influence the fluidity of the cell membranes as expressed by decreased whole-blood viscosity and increased erythrocyte flexibility and deformability [Gerster, cited above]. In addition, EFAs such as EPA and DHA are known precursors of eiconsanoids—a class of compounds which includes prostanoids such as prostaglandins and thromboxanes, leukotrienes, and hydroxy fatty acids. Eiconsanoids are known are known to affect platelet aggregation, permeability and tone of the blood vessel walls, blood pressure, and inflammatory immune reactions. [Gerster, cited above].
Fish oil dietary supplementation is known to have other beneficial health effects. Glycogen storage disease is an inherited disorder, and is often complicated by severe hyperlipoproteinemia and hypercholesterolemia, which increase the risk of premature atherosclerosis and cadiovascular diseases. It has been reported that patients suffering from glycogen storage disease that received 10 grams of fish oil for 3 months experienced a significant decrease in levels of triglycerides in the blood serum (−49%) and cholesterol levels in the blood serum (−23%), and a reduction in LDL levels in the blood serum (−40%), and a significant increase in HDL levels in the blood serum (+30%). [Levy, E., et al.,
I. Am. J. Clin. Nutr.,
57:922-29 (1993)].
Garlic powder has been proposed to have a number of valuable benefits to the human body as a preventative against cardiovascular diseases. For example, daily ingestion of garlic leads to reduced levels of lipids in human blood serum, increased fibrinolysis and tissue plasminogen activator (t-PA) activity, and decreased plasma fibrogen viscosity, each of which may lessen the likelihood of cardiovascular disease. [Brosche, T. et al.,
British J. Clin. Practice, Supp.
69:12-19 (1990); Kiesewetter H. et al.,
British J. Clin. Practice, Supp.
69:24-29 (1990)]. In addition, the daily ingestion of garlic is known to reduce the total levels of cholesterol and triglycerides in human serum, as well as reduce blood pressure peripheral vasodilation. [Auer, W. et al.,
British J. Clin. Practice, Supp.
69:3-6 (1990)].
Flavonoids are secondary metabolites which are found in edible plants and foodstuffs derived from plants. Flavonoids are widely recognized as having antiallergic, anti-flammatory, antiviral, antiproliferative and anticarcinogenic activities. [Manach, C., et al.
J. Nutr.,
125:1911-22 (1995)]. Among flavonoids, flavonols occur most abudantly in plants as possess most of these biological properties. [Manach, cited above]. Flavonols naturally occur as O-glycides, typically having a sugar moiety bound at the C-3 position. Rutin is the principal glycoside form of quercetin, the most abundant flavonol in fruits and vegetables.
Capsaicin is a prominent chemical entity in plants of the Capsicum genus, which include chili peppers, red pepper, and paprika. Capsaicin is actually a class of compounds of branched- and straight-chain alkyl vanillylamides. The antimicrobial and analgesic properties of capsaicin have been known for centuries. In addition, capsaicin-containing products have been used to treat rheumatoid arthritis, osteoarthritis, diabetic neuropathy, postherpetic neuralgia, postmastectomy pain syndrome, cluster headache, and reflex sympathetic syndrome. [Cordell, G. and Araujo, O.,
Ann. Pharm.,
27:330-36 (1993)].
Although compositions used to reduce the risks of cardiovascular disease are known, the present invention comprises a novel combination of fish oil, garlic, rutin, and capsaicin, which achieve this purpose. As such, there remains a need in the art for novel compositions like those of the present invention which may be used to treat or prevent cardiovascular disease and disorders.
SUMMARY OF THE INVENTION
The present invention relates to the use of nutritional supplement compositions to overcome the nutritional deficiencies typically associated with the normal Western diet. The compositions of the present invention are obtained by combining fish oil, garlic powder, rutin, and capsaicin, Specifically, the present invention relates to the daily co-administration of one preparation of fish oil, preferably as a single fish oil lozenge, and a preparation comprised of garlic powder, rutin, and capsaicin, preferably in a single lozenge.
It is therefore an object of the invention to provide nutritious and safe compositions for human consumption as dietary supplements that contain fish oil, garlic powder, rutin, and capsaicin.
It is another object to provide novel compositions which will increase the levels of HDL in human blood serum.
It is a further object of the invention to provide compositions which will decrease levels of O-LDL in human

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