Efficacy of Provex CV Supplement to Reduce Inflammation Cytokines and Blood Pressure

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Blood Pressure

Intervention / Treatment
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* Drug: Provex CV
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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, unwillingness to stop current supplement intake or use of calcium/ magnesium antacids.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Participants will consume 330 mg of Provex CV supplement, by mouth, per day, for 4 weeks followed by 4 weeks of 330 mg of placebo (cornstarch) | Drug: Provex CV<br>* dietary supplement, 2 capsules per day by mouth<br>Other: placebo<br>* corn starch, 2 capsules per day by mouth<br>|
| Experimental: Arm 2<br>Participants will consume 330 mg placebo (cornstarch), by mouth, per day for 4 weeks followed by 4 weeks of 330 mg of ProvexCV for 4 weeks. | Drug: Provex CV<br>* dietary supplement, 2 capsules per day by mouth<br>Other: placebo<br>* corn starch, 2 capsules per day by mouth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 4 weeks after supplement or placebo |