Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00554242
Recruitment Status : Completed
First Posted : November 6, 2007
Last Update Posted : June 18, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Dietary Supplement: Grape seed extract and ascorbic acid Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Chronic Study of the Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function in Patients With Coronary Artery Disease
Study Start Date : July 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Dietary Supplement: Grape seed extract and ascorbic acid
    Grape seed extract 450 mg and ascorbic acid 1500 mg daily

Primary Outcome Measures :
  1. Brachial artery flow-mediated dilation [ Time Frame: 1 month ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00554242

Layout table for location information
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Layout table for investigator information
Principal Investigator: Joseph A Vita, MD Boston Medical Center
Layout table for additonal information
Responsible Party: Joseph A. Vita, MD, Boston University School of Medicine Identifier: NCT00554242    
Other Study ID Numbers: H-26356
First Posted: November 6, 2007    Key Record Dates
Last Update Posted: June 18, 2009
Last Verified: June 2009
Keywords provided by Boston University:
Additional relevant MeSH terms:
Layout table for MeSH terms
Grape Seed Extract
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Ascorbic Acid
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents