Red Wine and Ageing and Atherosclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01268254
First received: December 28, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  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

Ages Eligible for Study:   50 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 ext -    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

No publications provided

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
Study First Received: December 28, 2010
Last Updated: December 28, 2010
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on September 18, 2014