Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/88—Liliopsida (monocotyledons)
  • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
  • A61K36/8962—Allium, e.g. garden onion, leek, garlic or chives
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
  • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
  • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
  • A23L33/12—Fatty acids or derivatives thereof

Definitions

• 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.
• 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.
• 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 (0- 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, 0-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.
• HDL high density lipoprotein
• EFAs Essential fatty acids
• EPA eicosapantaenoic acid
• DHA docosahexaenoic acid
• EFAs such as EPA and DHA are known precursors of eicosanoids -- a class of compounds which includes prostanoids such as prostaglandins and thromboxanes, leukotrienes, and hydroxy fatty acids. Eicosanoids 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] .
• Glycogen storage disease is an inherited disorder, and is often complicated by severe hyperlipoproteinemia and hypercholesterolemia, which increase the risk of premature atherosclerosis and cardiovascular 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.
• t-PA tissue plasminogen activator
• Flavonoids are secondary metabolites which are found in edible plants and foodstuffs derived from plants. Flavonoids are widely recognized as having antiallergic, anti-inflammatory, antiviral, antiproliferative and anticarcinogenic activities. [Manach, C, et al. J. Nutr. , 125:1911-22 (1995)]. Among flavonoids, flavonols occur most abundantly 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, 0. , Ann. Pharm.. 2_7:330-36 (1993)].
• 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.
• 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.
• 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.
• 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 blood serum.
• LDL should act to reduce the risk of heart disease in humans.
• compositions of the present invention are aimed at reducing the rate of occurrence of heart disease and are comprised of: (1) fish oil; (2) garlic powder; (3) rutin; and (4) capsaicin. More specifically, the compositions of the present invention are a combination of a fish oil preparation, preferably in the form of a single fish oil lozenge, and a preparation comprised of garlic powder, rutin, and capsaicin, preferably in the form of a single lozenge which is co-administered with the fish oil lozenge.
• the preferred weight of the fish oil lozenge is between about 500 mg and about 1500 mg, preferably about 1000 mg.
• the preferred weight of the garlic lozenge is between about 400 mg and about 1000 mg, and most preferably about 700 mg.
• the fish oil preparation component of the compositions of the present invention may be available from commercial sources. [Arista, Pharmachem] .
• EPA and DHA are the active moieties of the fish oil preparation.
• the fish oil preparation of the present invention comprises EPA in the amount of about 250 mg to about 350 mg, and most preferably about 300 mg.
• the remainder of the fish oil preparation comprises from about 150 mg to about 250 mg of DHA, and preferably about 200 mg of DHA.
• the total weight of the fish oil preparation of the present invention is from about 500 mg to about 1500 mg, and preferably about 1000 mg per fish oil lozenge when in the form of a single fish oil lozenge.
• the garlic powder used in the garlic powder, rutin, and capsaicin preparation component of the compositions of the present invention may be obtained from commercially available sources. [Extracts, Ashland, Pure-Gar] .
• a pharmaceutically acceptable form of garlic powder used in the compositions of the present invention comprises, by weight, from about 100 mg to about 700 mg, and more preferably about 175 mg to about 650 mg, and most preferably 500 mg of deodorized and aged garlic powder per garlic/rutin/capsaicin lozenge when in the form of a single lozenge.
• the rutin which is employed in the garlic powder, rutin, and capsaicin preparation component of the compositions of the present invention may also be obtained from commercially available sources. [Westco Chemical, Freeman Industries, Inc.] .
• the rutin component of the garlic powder, rutin, and capsaicin preparation comprised, by weight, from about 10 mg to about 150 mg, and most preferably about 100 mg.
• Capsaicin which is used in the compositions of the present inventions may be commercially obtained. [AllChem, Good Hope Botanicals] .
• the capsaicin component of the compositions of the present invention comprises, by weight, from about 20 mg to about 150 mg, and most preferably about 100 mg of capsaicin.
• the garlic powder, rutin, and capsaicin components are admixed in the same preparation. This preparation is co- administered with the fish oil preparation -- the two preparations comprising the compositions of the present invention. These preparations may be made by conventional methods.
• compositions of the invention are combined as the active ingredient in intimate admixture with a suitable carrier according to conventional compounding techniques.
• This carrier may take a wide variety of forms depending upon the form of preparation desired for administration, e.g., oral, sublingual, nasal, or parenteral.
• any of the usual pharmaceutical media may be employed.
• oral liquid preparations e.g., suspensions, elixirs, and solutions
• media containing for example, water, oils, alcohols, flavoring agents, preservatives, coloring agents and the like may be used.
• Carriers such as starches, sugars, diluents, granulating agents, lubricants, binders, disintegrating agents, and the like may be used to prepare oral - solids (e.g., powders, capsules, pills, tablets, and lozenges) .
• Lozenges are a preferred oral dosage form. Controlled release forms may also be used.
• lozenges, tablets, pills, and capsules represent the most advantageous oral dosage unit form, in which case solid pharmaceutical carriers are obviously employed.
• tablets may be sugar coated or enteric coated by standard techniques.
• additional inactive components which provide for easier oral administration include but are not limited to lemon bioflavonoids [Botanical International, Freeman], parsley powder, d-alpha tocopherol, bee's wax, lecithin, gelatin, purified water, and glycerin. These compounds may be used in creating the lozenges of the novel nutritional supplements.
• the carrier will usually comprise sterile water, although other ingredients may be included, e.g., to aid solubility or for preservation purposes.
• injectable suspensions may also be prepared, in which case appropriate liquid carriers, suspending agents, and the like may be employed.
• a preferred method for using the present invention is for the user to ingest, daily from about 4 to 8 lozenges of the fish oil preparation, most preferably about 6 lozenges of the fish oil preparation, together with from about 3 to 5 lozenges of the garlic powder, capsaicin and rutin preparation, and most preferably 4 lozenges of the garlic powder, capsaicin and rutin preparation.
• the following examples illustrate the preferred embodiments of the present invention. These examples are illustrative only, and do not purport to limit the invention in any fashion.
• EXAMPLE 1 The effect of the present invention on the human lipid profile was measured. A double blind study carried out at the University of California at Irvine Medical School showed that the proper use of the present invention provides for the following effects in human blood serum: (1) a significant reduction in triglyceride levels; (2) a significant decrease in cholesterol and LDL; and (3) a significant increase in the levels of HDL.
• the protocol followed during this investigation was as follows. Ten subjects participated in a month-long study wherein each subject ingested ten lozenges for each day of the study.
• the placebo group used 10 nonactive lozenges each day for one month, and the active group ingested 10 lozenges of the present invention each day for one month.
• EXAMPLE 2 The following example provides a preferred composition of the present invention.
• the composition is provided as two separate preparations: lozenge A (fish oil) and lozenge B (garlic, capsaicin, and rutin) .
• the proper daily dosage is six of lozenge A and four of lozenge B (in other words, three of lozenge A and two of lozenge B taken twice daily for a total of ten lozenges) .
• the following example provides a preferred composition of the present invention.
• the composition is provided as two separate preparations: Lozenge A (fish oil) and Lozenge B (garlic, capsaicin, rutin) .
• the proper dosage is six capsules of Lozenge A each day and four capsules of Lozenge B (in other words, three of lozenge A and two of lozenge B taken twice daily for a total of ten lozenges) .
• EXAMPLE 4 The following example provides a preferred composition of the present invention.
• the composition is provided as a single preparation.
• the proper dosage is five capsules of the lozenge taken twice each day.

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• 1996
  • 1996-06-17 AU AU62827/96A patent/AU6282796A/en not_active Abandoned
  • 1996-06-17 WO PCT/US1996/010500 patent/WO1997033599A1/en not_active Application Discontinuation
  • 1996-06-17 EP EP96921665A patent/EP0835119A4/de not_active Withdrawn
  • 1996-06-17 CN CN96195324A patent/CN1190347A/zh active Pending

Non-Patent Citations (3)

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