- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00755014
Study Effect of Red Wine Consumption on Endothelial Progenitor Cells and Endothelial Function
Taipei Veterans General Hospital
Study Overview
Status
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Taipei, Taiwan, 112
- Taipei Veterans Generla Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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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:
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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
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Collaborators and Investigators
Collaborators
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
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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.
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