Skip to main content
OpenTrials
Completed

NCT Number: NCT00554242

Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Grape seed extract and ascorbic acid

Dietary Supplement

Grape seed extract 450 mg and ascorbic acid 1500 mg daily

Primary outcomes

  1. Brachial artery flow-mediated dilation

    Time frame: 1 month

Secondary outcomes

  1. Fingertip Pulse Amplitude Tonometry

    Time frame: 1 month

  2. Carotid-femoral pulse wave velocity

    Time frame: 1 month

  3. Serum markers of inflammation

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Boston University

Other

Registry information

Official study title

Chronic Study of the Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function in Patients With Coronary Artery Disease

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 6, 2007
Registry last updated
Jun 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.