Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT00554242
• Lead Sponsor: Boston University

Brief Summary

A pilot study of 15 subjects will be conducted to confirm an acute effect of grape seed extract on endothelial function. We then will perform a a randomized, double blind, placebo controlled crossover study designed to investigate the benefit of grape seed extract/vitamin C treatment on endothelial function. Participants (n=40) will take a food supplement containing 450 mg of grape seed extract and 1500 mg of vitamin C or matching placebo for four weeks and then cross over to the alternative treatment (active supplement or placebo) for four weeks. We will examine endothelial function before and after each of the two treatment periods. The study will provide information about the vascular effects of these compounds.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-11-05
• Study First Submitted QC: 2007-11-05
• Study First Posted: 2007-11-06
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-16
• Last Update Posted: 2009-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Coronary artery disease

Exclusion Criteria

• Pregnancy
• Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate.
• Treatment with an investigational new drug within the last 30 days.
• History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
• Vitamin E, Vitamin C, and beta carotene, lipoic acid, and other food or herbal supplements within 1 month of enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Brachial artery flow-mediated dilation	1 month

Secondary Outcome Measures

Name	Time	Method
Fingertip Pulse Amplitude Tonometry	1 month
Carotid-femoral pulse wave velocity	1 month
Serum markers of inflammation	1 month

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States