Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function

NCT00554242 | Completed

• 1 other identifier: H-26356
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

endothelium; antioxidants; flavonoids

Outcome Measures

Primary Outcomes (1)

• Brachial artery flow-mediated dilation

  1 month

Secondary Outcomes (3)

• Fingertip Pulse Amplitude Tonometry

  1 month

• Carotid-femoral pulse wave velocity

  1 month

• Serum markers of inflammation

  1 month

Interventions

Grape seed extract and ascorbic acid DIETARY_SUPPLEMENT

Grape seed extract 450 mg and ascorbic acid 1500 mg daily

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Coronary artery disease

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Grape Seed Extract; Ascorbic Acid

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Joseph A Vita, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 5, 2007
• First Posted: November 6, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 18, 2009

Record last verified: 2009-06

Locations

US (1)