Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554242
• Other study ID #: H-26356
• Status: Completed
• Phase: N/A
• First received: November 5, 2007
• Last updated: June 16, 2009
• Start date: July 2007
• Est. completion date: December 2008

Study information

• Verified date: June 2009
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial artery flow-mediated dilation		1 month	No
Secondary	Fingertip Pulse Amplitude Tonometry		1 month	No
Secondary	Carotid-femoral pulse wave velocity		1 month	No
Secondary	Serum markers of inflammation		1 month	No