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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01106170
First received: April 15, 2010
Last updated: January 13, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Blood Pressure
Drug: Provex CV
Other: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 4 weeks after supplement or placebo ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: March 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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.
Drug: Provex CV
dietary supplement, 2 capsules per day by mouth
Other: placebo
corn starch, 2 capsules per day by mouth

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106170

Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Thunder Jalili, Ph.D. University of Utah
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01106170     History of Changes
Other Study ID Numbers: 31886 Melaluca-ProvexCV
Study First Received: April 15, 2010
Last Updated: January 13, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 27, 2015