- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00554242
Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function
June 16, 2009 updated by: Boston University
Chronic Study of the Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function in Patients With Coronary Artery Disease
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Brachial artery flow-mediated dilation
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Carotid-femoral pulse wave velocity
Time Frame: 1 month
|
1 month
|
Fingertip Pulse Amplitude Tonometry
Time Frame: 1 month
|
1 month
|
Serum markers of inflammation
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
November 5, 2007
First Submitted That Met QC Criteria
November 5, 2007
First Posted (Estimate)
November 6, 2007
Study Record Updates
Last Update Posted (Estimate)
June 18, 2009
Last Update Submitted That Met QC Criteria
June 16, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Protective Agents
- Antineoplastic Agents, Phytogenic
- Micronutrients
- Vitamins
- Antioxidants
- Ascorbic Acid
- Grape Seed Extract
Other Study ID Numbers
- H-26356
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
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