Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2002-09-24
2004-09-07
Leith, Patricia (Department: 1654)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S776000, C424S489000
Reexamination Certificate
active
06787162
ABSTRACT:
TECHNICAL FIELD
The present invention relates to methods and compositions for the control of blood cholesterol. Specifically, the invention relates to a method for reducing elevated blood cholesterol and blood triglyceride concentrations in mammals, comprising administration of therapeutically sufficient amounts of preparations derived from the seed of the
Persea americana
fruit, and to compositions comprising these preparations.
BACKGROUND OF THE INVENTION
Elevated cholesterol is associated with a greater-than-normal risk of atherosclerosis and cardiovascular disease. Factors known to affect blood cholesterol include diet, body weight, physical activity or lack thereof, age, and sex. While cholesterol in normal amounts is a vital building block for essential organic molecules such as steroids, cell membranes, and bile acids, cholesterol in excess is known to contribute to cardiovascular disease. For example, cholesterol is a major element of plaque which collects in coronary arteries, resulting in cardiac disease.
Traditional therapies for reducing cholesterol include medications such as statins (which reduce production of cholesterol by the body). More recently, the value of nutrition and nutritional supplements in reducing blood cholesterol has received significant attention. For example, dietary compounds such as soluble fiber, vitamin E, soy, garlic, omega-3 fatty acids, and niacin have all received significant attention and research funding.
Despite the attention focused on traditional and alternative means for controlling blood cholesterol, blood triglycerides, and the like, the fact remains that it is estimated that greater than 50% of the population of the United States has cholesterol levels in the range of from 200-239 mg/dL, or what is considered borderline elevated. There thus remains a need in the art for alternative methods and compositions for reducing blood cholesterol, blood triglycerides, blood pressure, and the harmful effects thereof. The present invention satisfies this need in the art by providing a method for reduction of blood cholesterol and triglyceride concentrations. The invention further provides compositions for effecting reduction in blood cholesterol and triglyceride concentrations, in accordance with the methods described.
SUMMARY OF THE INVENTION
In accordance with the purposes of the present invention as described herein, a novel method is described for reducing blood cholesterol concentration and blood triglyceride concentration in a mammal. The invention is based on the surprising discovery that preparations derived from the seed of the
Persea americana
tropical fruit, also known as the avocado, provide an unexpected reduction in levels of blood cholesterol in individuals consuming them. Accordingly, the method of the present invention comprises administering a therapeutically effective amount of a preparation of the seed of
Persea americana
. The preparations of the present invention may be administered to any mammal wherein it is desired to reduce levels of blood cholesterol, including humans.
In one aspect of the present invention, the preparation may comprise a powder derived by the steps of slicing, crushing, or chopping the seed, drying the seed to a moisture content of up to 1%, and grinding the seed to reduce particle size. The seed may be dried by oven drying. Typically, the seed will be oven dried at 50 C to a moisture content of up to 1%. The dried seed preparation may then be ground to reduce particle size. Typically, the preparation will be ground to achieve a particle size of up to 1000 &mgr;m.
In another aspect, the present invention provides a method for reducing blood cholesterol concentration and blood triglyceride concentration in a mammal, comprising administering a therapeutically effective amount of an extract of the seed of
Persea americana
. It will be appreciated that any suitable extract for administration of the preparation of the present invention to a mammal may be used. Typically, the extract will be an aqueous extract derived by the steps of slicing, crushing, or chopping the seed of
Persea americana
, soaking the seed in water for at least 8 hours to form an extract, and filtering the seed to remove solids. The seed may also be macerated in water, such as by a conventional blender, prior to soaking and filtering. Typically, a ratio of water:seed of from about 5:1 to about 15:1 is used.
Typically, the method of the present invention comprises administration of from about 500 mg/day to about 2500 mg/day of the preparation of the seed of
Persea americana
. The preparation may be administered by admixing directly with food or beverages. Additionally, the preparation may be administered in any suitable supplement form, such as tablets, capsules, gelcaps, powders, suspensions, solutions, emulsions, liquid compositions, syrups, and the like. The manufacture of such means for administering a supplement is well known to those skilled in the art.
In yet another aspect of the present invention, a composition is provided for reducing blood cholesterol and blood triglyceride concentration in a mammal such as a human, comprising a therapeutically effective amount of a preparation of the seed of
Persea americana
. The preparation of the present invention may be formulated for administration as a powder or as an extract as described above. Typically, the composition is formulated to provide from about 500 mg/day to about 2500 mg/day of the preparation of the seed of
Persea americana
. As noted above, the compositions of the present invention may be directly admixed with food or drink for administration. The compositions may also be formulated for administration as a nutritional supplement, a vitamin supplement, a pharmaceutical preparation, a food additive, a food supplement, and the like. The manufacture of such supplements is well known to those skilled in the art. The composition of the present invention may be incorporated into the above forms as manufactured, or may be formulated with a pharmaceutically acceptable carrier.
Additional objects, advantages and other novel features of the present invention will become apparent to those skilled in this art from the following description wherein there is shown and described a preferred embodiment of this invention, simply by way of illustration of the modes currently best suited to carry out the invention. To achieve the foregoing and other objects, and in accordance with the purposes of the present invention as described herein, a novel method is described for reducing blood cholesterol in mammals.
In particular, the invention provides a method and a composition for reducing blood cholesterol in mammals such as humans, comprising preparations derived from the seed of the
Persea americana
tropical fruit. When admixed with food or drink or administered as a supplement, the compositions surprisingly reduce undesirably elevated concentrations of blood cholesterol in humans or animals consuming them, thereby improving overall health. As it will be realized, the invention is capable of other different embodiments and its several details are capable of modification in various, obvious aspects all without departing from the invention. Accordingly, the descriptions will be regarded as illustrative in nature and not as restrictive.
REFERENCES:
Simpson, G. E. Folk Medicine in Trinidad; Journal of American Folklore (1962) pp. 1-4 as reported by Napralert database acessed on Oct. 30, 2003).
Bonilla Jose V.
King & Schickli PLLC
Leith Patricia
LandOfFree
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