Efficacy of Provex CV Supplement to Reduce Markers of Inflammatory Cytokines and Blood Pressure in Subjects With Metabolic Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of Utah.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT01106170
First received: April 15, 2010
Last updated: July 29, 2011
Last verified: July 2011
  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
Blood Pressure
Plasma Inflammatory Markers
Blood Aggregation Time
Dietary Supplement: ProvexCV
Dietary Supplement: Placebo

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 ]

Estimated Enrollment: 30
Study Start Date: March 2010
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ProvexCV Dietary Supplement: ProvexCV
dietary supplement, 2 capsules per day by mouth
Placebo Comparator: Placebo Dietary Supplement: Placebo
cornstarch, 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, or 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 Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Thunder Jalili, Ph.D.    801-585-0399    thunder.jalili@utah.edu   
Principal Investigator: Thunder Jalili, Ph.D.         
Sub-Investigator: Rodney Badger, M.D.         
Sponsors and Collaborators
University of Utah
  More Information

No publications provided

Responsible Party: Jeremy Ivie, VP of Research, Melaluca, Inc.
ClinicalTrials.gov Identifier: NCT01106170     History of Changes
Other Study ID Numbers: 31886 Melaluca-ProvexCV
Study First Received: April 15, 2010
Last Updated: July 29, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 21, 2014