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

NCT01106170 | Completed Phase 1

• 1 other identifier: 31886 Melaluca-ProvexCV
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  4 weeks after supplement or placebo

Study Arms (2)

Arm 1

EXPERIMENTAL

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; Other: placebo

Arm 2

EXPERIMENTAL

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; Other: placebo

Interventions

Provex CV DRUG

dietary supplement, 2 capsules per day by mouth

Arm 1; Arm 2

placebo OTHER

corn starch, 2 capsules per day by mouth

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• 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.

  PMID: 26059745 DERIVED

Study Officials

• Thunder Jalili, Ph.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 19, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

US (1)