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

This study has been completed.
Sponsor:
Collaborator:
National Yang Ming University
Information provided by:
Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier:
NCT00755014
First received: September 15, 2008
Last updated: September 17, 2008
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Endothelial Progenitor Cells Numbers
Endothelial Function (FMD)
 Other: red wine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Taipei Veterans General Hospital

Further study details as provided by Taipei Veterans General Hospital,Taiwan:

Primary Outcome Measures:
  • Number of endothelial progenitor cells, endothelial function (FMD) [ Time Frame: VGH-97DHA0100127 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma NO, hsCRP, ADMA, TNF-a, adiponectin, ox-LDL levels [ Time Frame: VGH-97DHA0100127 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2007
Study Completion Date: July 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755014

Locations
Taiwan
Taipei Veterans Generla Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital,Taiwan
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
  More Information

No publications provided

Responsible Party: Medial Resource and Education, Taipei Veterans General Hospital
ClinicalTrials.gov Identifier: NCT00755014     History of Changes
Other Study ID Numbers: VGHIRB No: 96-01-11A
Study First Received: September 15, 2008
Last Updated: September 17, 2008
Health Authority: Taiwan: Department of Health

ClinicalTrials.gov processed this record on May 16, 2013