Study Effect of Red Wine Consumption on Endothelial Progenitor Cells and Endothelial Function

September 17, 2008 updated by: Taipei Veterans General Hospital, Taiwan

Taipei Veterans General Hospital

Light-to-moderate alcohol consumption has been associated with a reduction of cardiovascular events, and red wine seems to offer more benefits than any other type of alcoholic beverages. However, the relationship between red wine consumption and endothelial progenitor cells (EPCs) remains unclear. The investigators examine whether intake of red wine could enhance the number or functional capacity of circulating EPCs by upregulation of nitric oxide (NO) bioavailability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Moderate ethanol intake from any type of beverage has been shown to improve lipoprotein metabolism and lower cardiovascular mortality risk, but red wine, with its abundant antioxidant contents, seems to confer additional healthy benefits. Previous studies indicated that the beneficial effects of red wine are derived from increased endothelium-derived nitric oxide (NO), implying that enhanced NO bioavailability may mediate the cardiovascular protection provided by red wine.

Increasing evidence suggests that the injured endothelial monolayer is regenerated partly by circulating bone marrow derived-endothelial progenitor cells (EPCs), which accelerate reendothelialization and protect against the initiation and progression of atherosclerosis. Clinical studies demonstrated that the number of circulating EPCs predicts the occurrence of cardiovascular events and death from cardiovascular causes and may help to identify patients at increased cardiovascular risk. Although many epidemiologic studies have indicated that light-to-moderate consumption of red wine can reduce the incidence of CAD, the multifarious effects of red wine on circulating EPCs and endothelial function remain to be determined. Therefore, we design this study to test the hypothesis that intake of red wine can enhance the number and functional capacity of EPCs through increasing NO bioavailability.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

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

  • Taiwan
      • Taipei, Taiwan, 112
        • Taipei Veterans Generla Hospital

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Forty young healthy subjects with no cardiovascular risk factors

Exclusion Criteria:

  • History of hypertension
  • Diabetes mellitus
  • Symptoms of CAD
  • Smoking
  • Chronic renal insufficiency (serum creatinine > 1.5 mg/dl)
  • Inflammatory or liver diseases
  • Regular alcohol consumption (drinking more than 20 g of ethanol per week)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Forty subjects are randomized to a group (n=20) that consumed red wine (100 ml) or a group (n=20) that consumed beer (250 ml) daily for 3 weeks
Other: red wine
One group (n=20) that consumed red wine (100 ml) daily for 3 weeks Another group (n=20) that consumed beer (250 ml) daily for 3 weeks
Other Names:
  • The red wine used is "Vin De Pays D'OC" (12.5% ethanol), a cabernet sauvignon from France
  • The beer used was Taiwan Beer (5% alcohol) from Taiwan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of endothelial progenitor cells, endothelial function (FMD)
Time Frame: VGH-97DHA0100127
VGH-97DHA0100127

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma NO, hsCRP, ADMA, TNF-a, adiponectin, ox-LDL levels
Time Frame: VGH-97DHA0100127
VGH-97DHA0100127

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Collaborators

National Yang Ming University

Investigators

  • Principal Investigator: Shing-Jong Lin, MD, PhD, Division of Cardiology, Taipei Veterans General Hospital
  • Study Director: Po-Hsun Huang, MD, Division of Cardiology, Taipei Veterans General Hospital

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

September 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

September 15, 2008

First Submitted That Met QC Criteria

September 17, 2008

First Posted (Estimate)

September 18, 2008

Study Record Updates

Last Update Posted (Estimate)

September 18, 2008

Last Update Submitted That Met QC Criteria

September 17, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHIRB No: 96-01-11A

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.

Subscribe