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Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Grape seed extract and ascorbic acid

About this trial

This is an interventional basic science trial for Coronary Artery Disease focused on measuring endothelium, antioxidants, flavonoids

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Boston Medical Center

Outcomes

Primary Outcome Measures

Brachial artery flow-mediated dilation

Secondary Outcome Measures

Fingertip Pulse Amplitude Tonometry

Carotid-femoral pulse wave velocity

Serum markers of inflammation

Full Information

NCT ID

NCT00554242

First Posted

November 5, 2007

Last Updated

June 16, 2009

Sponsor

Boston University

1. Study Identification

Unique Protocol Identification Number

NCT00554242

Brief Title

Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Boston University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

endothelium, antioxidants, flavonoids

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Dietary Supplement

Intervention Name(s)

Grape seed extract and ascorbic acid

Intervention Description

Grape seed extract 450 mg and ascorbic acid 1500 mg daily

Primary Outcome Measure Information:

Title

Brachial artery flow-mediated dilation

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Fingertip Pulse Amplitude Tonometry

Time Frame

1 month

Title

Carotid-femoral pulse wave velocity

Time Frame

1 month

Title

Serum markers of inflammation

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph A Vita, MD

Organizational Affiliation

Boston Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

12. IPD Sharing Statement

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Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function

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