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Red Wine and Ageing and Atherosclerosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by University of Sao Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01268254
First Posted: December 29, 2010
Last Update Posted: December 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
  Purpose

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.


Condition
Coronary Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Red Wine Project: a Study of Ageing Indexes and Prevalence of Atherosclerosis in Regular Red Wine Consumers Versus Abstainers

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Biospecimen Retention:   Samples With DNA
total blood sample

Estimated Enrollment: 200
Study Start Date: October 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
red wine
red wine usual consumer versus abstemious

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • asiatic or with manifest atherosclerosis disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268254


Locations
Brazil
Heart Insitute ( InCor) University of Sao Paulo Recruiting
Sao Paulo, Brazil, 05403-000
Contact: Protasio L Da Luz, mD, PhD    55 11 3069 5952    daluzp@incor.usp.br   
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Protasio L Da Luz, MD, PhD University of Sao Paulo
  More Information

Responsible Party: Protasio Lemos da Luz/ Cardiology Professor, Heart Insitute (InCor) Clinical Hospital of School Medicine University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01268254     History of Changes
Other Study ID Numbers: 1-48200805
First Submitted: December 28, 2010
First Posted: December 29, 2010
Last Update Posted: December 29, 2010
Last Verified: September 2010

Keywords provided by University of Sao Paulo:
wine
aging
atherosclerosis
telomere
tomography
coronary vessels

Additional relevant MeSH terms:
Atherosclerosis
Coronary Disease
Coronary Artery Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases


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