Clinical trial NCT01106170: Efficacy of Provex CV Supplement to Reduce Inflammation Cytokines and Blood Pressure
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Blood Pressure
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2010-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Blood pressure
timeFrame: 4 weeks after supplement or placebo
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Thunder Jalili, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.