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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01106170

Enrollment

Registered

2010-04-19

Start date

2010-03-31

Completion date

2011-10-31

Last updated

2015-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Brief summary

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.

Interventions

DRUGProvex CV

dietary supplement, 2 capsules per day by mouth

OTHERplacebo

corn starch, 2 capsules per day by mouth

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Blood pressure	4 weeks after supplement or placebo

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026