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

• ClinicalTrials.gov Identifier: NCT01106170
• Recruitment Status: Completed
• First Posted: April 19, 2010
• Last Update Posted: January 14, 2015
• Sponsor: University of Utah
• Information provided by (Responsible Party): University of Utah

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Blood Pressure	Drug: Provex CV; Other: placebo	Phase 1

Study Design

• 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

Arms and Interventions

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)	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

Outcome Measures

Primary Outcome Measures :

1. Blood pressure [ Time Frame: 4 weeks after supplement or placebo ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Biesinger S, Michaels HA, Quadros AS, Qian Y, Rabovsky AB, Badger RS, Jalili T. A combination of isolated phytochemicals and botanical extracts lowers diastolic blood pressure in a randomized controlled trial of hypertensive subjects. Eur J Clin Nutr. 2016 Jan;70(1):10-6. doi: 10.1038/ejcn.2015.88. Epub 2015 Jun 10.

• Responsible Party: University of Utah
• ClinicalTrials.gov Identifier: NCT01106170
• Other Study ID Numbers: 31886 Melaluca-ProvexCV
• First Posted: April 19, 2010
• Last Update Posted: January 14, 2015
• Last Verified: January 2015