Study Effect of Red Wine Consumption on Endothelial Proge... | NCT00755014

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

NCT00755014

Sponsor

Taipei Veterans General Hospital, Taiwan

Status

Completed

Last Update Posted

Sep 18, 2008Estimated

Enrollment

40Actual

Phase

Phase 1

Conditions

Endothelial Progenitor Cells Numbers
Endothelial Function (FMD)

Interventions

red wine

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Mar 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Sep 15, 2008

First Submission Date that Met QC Criteria

Sep 17, 2008

First Posted Date

Sep 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2008

Last Update Posted Date

Sep 18, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Taipei Veterans General Hospital, TaiwanOTHER_GOV

Collaborators

Name	Class
National Yang Ming Chiao Tung University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
red wine	Other	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	2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Veterans Generla Hospital		Taipei		112	Taiwan

Intervention Browse Module

MeSH Terms

ID	Term
D000431	Ethanol

Ancestor Terms

ID	Term
D000438	Alcohols
D009930	Organic Chemicals

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Browse Branches

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