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

Blood Pressure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106170
• Other study ID #: 31886 Melaluca-ProvexCV
• Status: Completed
• Phase: Phase 1
• First received: April 15, 2010
• Last updated: January 13, 2015
• Start date: March 2010
• Est. completion date: October 2011

Study information

• Verified date: January 2015
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Drug:
• Provex CV
dietary supplement, 2 capsules per day by mouth

Other:
• placebo
corn starch, 2 capsules per day by mouth

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure		4 weeks after supplement or placebo	No