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NCT01268254 Clinical Trial

Red Wine and Ageing and Atherosclerosis

Coronary Disease Clinical Trial

Official title:
The Red Wine Project: a Study of Ageing Indexes and Prevalence of Atherosclerosis in Regular Red Wine Consumers Versus Abstainers

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01268254
Other study ID # 1-48200805
Secondary ID
Status Recruiting
Phase N/A
First received December 28, 2010
Last updated December 28, 2010
Start date October 2009
Est. completion date April 2011

Study information
Verified date September 2010
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial Summary

The investigators will evaluate 100 regular red wine consumer men and 100 abstainers men from 50 years-old to 70 years-old by coronary risk prevalence, mood status, anthropometric measures, daily caloric ingest, lipid profile, carotid intimal media thickness, brachial flow mediate dilatation, coronary tomographic angiography and leucocyte telomere length.

The sample size has been calculated expecting that regular red wine ingestion would lead to a five year old younger vascular ageing indexes measured by carotid intimal media thickness, coronary artery calcium scores and leucocyte telomere length longer than those abstainers subjects at same age.

The investigators hypothesized that regular wine consumers present less coronary lesion and coronary calcium score on coronary tomographic angiography, lower carotid intimal media thickness and higher mean telomere length due the benefice of wine.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date April 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 50 Years to 70 Years
Eligibility Inclusion Criteria:

- healthy male, from 50 years-old to 70 years-old.

Exclusion Criteria:

- asiatic or with manifest atherosclerosis disease

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Brazil Heart Insitute ( InCor) University of Sao Paulo Sao Paulo

Sponsors (1)
Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

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