NCT01268254

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

December 29, 2010

Status Verified

September 1, 2010

Enrollment Period

1.4 years

First QC Date

December 28, 2010

Last Update Submit

December 28, 2010

Conditions

Keywords

wineagingatherosclerosistelomeretomographycoronary vessels

Study Arms (1)

red wine

red wine usual consumer versus abstemious

Eligibility Criteria

Age50 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

male subjects, between 50 years-old and 70 years-old, divided in 2 groups: usual red wine consumers and red wine abstemious

You may qualify if:

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

You may not qualify if:

  • asiatic or with manifest atherosclerosis disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Insitute ( InCor) University of Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

total blood sample

MeSH Terms

Conditions

Coronary DiseaseAtherosclerosis

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Protasio L Da Luz, MD, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 28, 2010

First Posted

December 29, 2010

Study Start

October 1, 2009

Primary Completion

March 1, 2011

Study Completion

April 1, 2011

Last Updated

December 29, 2010

Record last verified: 2010-09

Locations