Efficacy of Provex CV Supplement to Reduce Markers of Inflammatory Cytokines and Blood Pressure in Subjects With Metabolic Syndrome

Conditions:High Blood Pressure (Hypertension), Endocrine, Hematology
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Hematology
Age Range:18 - 65
Start Date:March 2010

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A Double-Blind, Placebo-Controlled, Crossover Evaluation of a Grape Seed Extract and Quercetin Supplement (Provex CV) to Reduce Markers of Inflammatory Cytokines and Blood Pressure in Subjects With Metabolic Syndrome

The purpose of this study is to determine if a supplement called Provex CV can reduce blood
pressure and other risk factors for heart disease. Heart disease is the leading cause of
death in this country and it is important to identify dietary factors, including
supplements, that can reduce heart disease risk factors. The supplement to be tested in this
study is made of a combination of natural compounds found in plants such as grapeseed
extract, green tea, and quercetin. Each compound individually has been shown to improve
blood pressure or reduce inflammation. We hypothesize that Provex CV will reduce blood
pressure and levels of inflammatory cytokines hypertensive patients with symptoms of
metabolic syndrome. This investigational trial of Provex CV has been approved by the United
States Food and Drug Administration.

Inclusion Criteria:

- Males (18 - 65) and postmenopausal females (up to age 65) with metabolic syndrome who
have stage 1 hypertension. Since all subjects will have Stage 1 hypertension, they
must also meet at least 2 of the following criteria of metabolic syndrome to qualify
for the study; waist circumference of >35 inches for women or >40 inches in men,
fasting plasma triglycerides of >150 mg/dl, fasting glucose of >100 mg/dl, HDL of <40
in men. Pre-hypertension or greater (130 + mm Hg systolic/80+mm Hg diastolic) is
defined by the 7th Report for the Joint National Committee on Prevention, Detection,
Evaluation, and Treatment of High Blood Pressure.

Exclusion Criteria:

- Subjects who are allergic to tea or grapes (on which the supplement is based).
Participants who have blood pressure less than 130 mmHg / 80 mmHg, have a history of
a prior cardiovascular event, diabetes, pregnancy, liver disease, renal
insufficiency, any chronic disease that might interfere with study participation, BMI
above 40 kg/m2, consumption of >12 alcoholic drinks weekly, or unwillingness to stop
current supplement intake or use of calcium/ magnesium antacids.
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