Grape Seed Extract And Vitamin C
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 |
| 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 :
- Brachial artery flow-mediated dilation [ Time Frame: 1 month ]
Secondary Outcome Measures :
- Fingertip Pulse Amplitude Tonometry [ Time Frame: 1 month ]
- Carotid-femoral pulse wave velocity [ Time Frame: 1 month ]
- Serum markers of inflammation [ Time Frame: 1 month ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
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 ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Joseph A. Vita, MD, Boston University School of Medicine |
| ClinicalTrials.gov 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:
| 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 Protective Agents Physiological Effects of Drugs Vitamins Micronutrients Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Grape Seed Extract And Vitamin C
Source: https://clinicaltrials.gov/ct2/show/NCT00554242
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