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Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function

This study has been completed.
Sponsor:
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00554242
First received: November 5, 2007
Last updated: June 16, 2009
Last verified: June 2009
History of Changes
  Purpose

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 Intervention
Coronary Artery Disease
 Dietary Supplement: Grape seed extract and ascorbic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston University:

Primary Outcome Measures:
  • Brachial artery flow-mediated dilation [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fingertip Pulse Amplitude Tonometry [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Carotid-femoral pulse wave velocity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Serum markers of inflammation [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Grape seed extract and ascorbic acid
    Grape seed extract 450 mg and ascorbic acid 1500 mg daily
  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554242

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Joseph A Vita, MD Boston Medical Center
  More Information

No publications provided

Responsible Party: Joseph A. Vita, MD, Boston University School of Medicine
ClinicalTrials.gov Identifier: NCT00554242     History of Changes
Other Study ID Numbers: H-26356
Study First Received: November 5, 2007
Last Updated: June 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
endothelium
antioxidants
flavonoids

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ascorbic Acid
Grape Seed Extract
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013