Efficacy of Provex CV Supplement to Reduce Inflammation Cytokines and Blood Pressure
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ClinicalTrials.gov Identifier: NCT01106170 |
Recruitment Status :
Completed
First Posted : April 19, 2010
Last Update Posted : January 14, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Blood Pressure | Drug: Provex CV Other: placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official 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 |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | October 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1
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)
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Drug: Provex CV
dietary supplement, 2 capsules per day by mouth Other: placebo corn starch, 2 capsules per day by mouth |
Experimental: Arm 2
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.
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Drug: Provex CV
dietary supplement, 2 capsules per day by mouth Other: placebo corn starch, 2 capsules per day by mouth |
- Blood pressure [ Time Frame: 4 weeks after supplement or placebo ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106170
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84112 |
Principal Investigator: | Thunder Jalili, Ph.D. | University of Utah |
Responsible Party: | University of Utah |
ClinicalTrials.gov Identifier: | NCT01106170 |
Other Study ID Numbers: |
31886 Melaluca-ProvexCV |
First Posted: | April 19, 2010 Key Record Dates |
Last Update Posted: | January 14, 2015 |
Last Verified: | January 2015 |