Composition and method for lowering cholesterol

Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from a bark

Reexamination Certificate

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C424S774000

Reexamination Certificate

active

06793946

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to compositions and methods for lowering cholesterol. More particularly, the present invention relates compositions and methods having avocado leaf of the species
Persea americana
var.
drymifolia
(hereinafter referred to as “
drymifolia
”) for use in lowering cholesterol levels in humans.
BACKGROUND OF THE INVENTION
Cholesterol is a soft, waxy substance found among the lipids in the bloodstream and in cells of the human body. Although cholesterol serves needed bodily functions, too high a level of cholesterol in the blood may be detrimental to a person's health because it increases the risk of cardiovascular disease. High cholesterol generally means that a person's total blood cholesterol level is more than 240 mg/dl or that a person's low density lipoprotein level is more than 160 mg/dl (see, Cleeman, James I., Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III),
JAMA
285(19): 2486-2497 (2001)). Approximately 41.3 million Americans have total blood cholesterol levels of 240mg/dL or higher (see, American Heart Association, Biostatistical Fact Sheet, www.americanheart.org (2002)). When blood cholesterol reaches these high levels, it can build up on artery walls because cholesterol does not dissolve in the blood. Rather, cholesterol has to be transported to and from the cells by special carriers called low-density lipoproteins (LDL) and high density proteins (HDL). HDL carries cholesterol away from your arteries and is, thus, considered “good cholesterol.” Too much LDL cholesterol can clog the arteries to your heart and is, thus, considered “bad cholesterol.” This condition, called atherosclerosis, increases the risk of blood clots, heart attack, and stroke.
Accordingly, there is considerable amount of interest in regulating cholesterol level in the body. There are several classes of available lipid-regulating pharmacological interventions called statins. One common statin is LIPITOR®. Although these agents have been proven safe in clinical trials, like any drug, they carry the risk for side-effects. Most notable of the side-effects is myopathy, which becomes evident as muscle pains and weakness. Furthermore, it is important to minimize the potential for adverse reactions or drug interactions when a patient is undergoing statin therapy (see, Davidson, Michael H., Treatment of the Elderly with 3-Hydroxy-3-Methylglutaryl Coenzyme A Reductase Inhibitors: Focus on Drug Interactions,
J Cardiovasc Pharmacol Therapeut,
6(3): 219-229 (2001)). In its Adult Treatment Panel, the National Cholesterol Education Program recommends the use of plant derived substances in the adjuvant therapies for dyslipidemias (see Cleeman, supra). Accordingly, natural alternatives with effective and safe cholesterol reduction are desired.
SUMMARY OF THE INVENTION
The present invention is a composition containing avocado leaves from the variety
drymifolia
for reducing cholesterol levels. In one embodiment the leaves are dehydrated and milled for consumption as a tea. Surprisingly, the leaves of
drymifolia
showed a comparable cholesterol lowering effect to LIPITOR® and a much greater cholesterol lowering effect than the fruit and the leaves of
Persea nubigena
var.
guatamalensis
cv. Nabal and
Persea nubigena
var.
guatamalensis
cv. Haas, which are avocados commonly grown in North America.
These and other aspects and advantages of the present invention will be better understood by reference to the drawings and the detailed description of the preferred embodiment. It is noted that, unless otherwise stated, all percentages given in this specification and the appended claims refer to percentages by weight.


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Effects of a Vegetarian Diet vs. a Vegetarian Diet Enriched with Avocado in Hypercolesterolemic Patients, Carranza-Madrigal J; Herrera-Abarca J E; Alvizouri-Munoz M; Alvarado-Jimenez Mr; Chavez-Carbajal F.; Archives of Medical Research, (1997 Winter) 28 (4) 537-41. Abstract.
Comparison of the Effects on Lipoproteins and Apolipoproteins of Diet High in Monounsaturated Fatty Acids, enriched with Avocado, and a High-carbohydrate Diet; Colquhoun D M; Moores D; Somerset S M; Humpries J A, American Journal of Clinical Nutrition, (Oct. 1992) 56 (4) 671-7. Abstract.
Effects of Avocado as a Source of Monounsaturated Fatty Acids on Plasma Lipid Levels, Alvizouri-Munoz M; Carranza-Madrigal J; Herrera-Abarca J E; Chavez-Carbajal F; Amezcua-Gastelum JL, Archives of Medical Research, (1992 Winter) 23 (4) 163-7. Abstract.
Monounsaturated Fatty acid (avocado) Rich \Diet for Mild Hypercholesterolemia; Lopez Ledesma R; Frati Munari A C; Hernandez Dominguez B C; Cervantes; Montal Vo S; Hernandez Luna M H; Juarez C; Moran Lira S., Archives of Medical Research, (1996 Winter)27 (4) 519-23. Abstract.
Effects of Avocado on the Level of Blood Lipids in Patients with Phenotype II and IV Dyslipidemas; Carranza J; Alvizouri M; Alvarado M R; Chavez F; Gomez M; Herrera JE, Archivos Del Instituto De Cardiologia De Mexico, (Jul.-Aug. 1995) 65 (4) 342-8. Abstract.
Effect of High-monounsaturated Fat Diet enriched with Avocado in NIDDM Patients Lerman-Garber I; Ihazo-Cerro S; Zamora-Gonzalez J; Cardoso-Saldana G; Posadas-Romero C;, Diabetes Care, (Apr. 1994) 17 (4) 311-5. Abstract.
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Avocados Protect Liver: Going Nuts—A Guide to the Wonderfully Nutritoous World of Nuts; Dr. Stephen Byrnes, (http://powerhealth.net/archivmidm rch2001.htm), reprinted from Ralph Moss′ Newsletter at http://www.cancerdecisions.com.

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