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

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.

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Key information

Conditions

Blood Pressure

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Provex CV

Drug

dietary supplement, 2 capsules per day by mouth

Placebo

Other

corn starch, 2 capsules per day by mouth

Primary outcomes

Blood pressure

Time frame: 4 weeks after supplement or placebo

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Apr 19, 2010
Registry last updated: Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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