NCT00755014

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
Last Updated

September 18, 2008

Status Verified

September 1, 2008

Enrollment Period

6 months

First QC Date

September 15, 2008

Last Update Submit

September 17, 2008

Conditions

Endothelial Progenitor Cells NumbersEndothelial Function (FMD)

Outcome Measures

Primary Outcomes (1)

  • Number of endothelial progenitor cells, endothelial function (FMD)

    VGH-97DHA0100127

Secondary Outcomes (1)

  • Plasma NO, hsCRP, ADMA, TNF-a, adiponectin, ox-LDL levels

    VGH-97DHA0100127

Study Arms (1)

2

EXPERIMENTAL

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

Interventions

red wineOTHER

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

Also known as: 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.
2

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Forty young healthy subjects with no cardiovascular risk factors

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans Generla Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Shing-Jong Lin, MD, PhD

    Division of Cardiology, Taipei Veterans General Hospital

    PRINCIPAL INVESTIGATOR

  • Po-Hsun Huang, MD

    Division of Cardiology, Taipei Veterans General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 15, 2008

First Posted

September 18, 2008

Study Start

September 1, 2007

Primary Completion

March 1, 2008

Study Completion

July 1, 2008

Last Updated

September 18, 2008

Record last verified: 2008-09

Locations

TW(1)