Coronary DiseaseNCT01268254
Red Wine and Ageing and Atherosclerosis
An observational study of Coronary Disease, run by University of Sao Paulo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 50 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Coronary Disease
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2009to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: male subjects, between 50 years-old and 70 years-old, divided in 2 groups: usual red wine consumers and red wine abstemious
Who may be able to join
- healthy male, from 50 years-old to 70 years-old.
Who cannot join
- asiatic or with manifest atherosclerosis disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Insitute ( InCor) University of Sao Paulo
São Paulo, São Paulo, 05403-000
Protasio L Da Luz, mD, PhD, 55 11 3069 5952, daluzp@incor.usp.br
About this study
Official title: The Red Wine Project: a Study of Ageing Indexes and Prevalence of Atherosclerosis in Regular Red Wine Consumers Versus Abstainers
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.
- Conditions
- Coronary Disease
- Keywords
- wine, aging, atherosclerosis, telomere, tomography, coronary vessels
- Medical subject headings
- Coronary Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| red wine | red wine usual consumer versus abstemious |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2010 (estimated)
- Study startOct 2009
- Primary completionMar 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Protasio L Da Luz, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268254
- Sponsor's protocol ID
- 1-48200805
- Status last verified
- Sep 2010
- First submitted
- 28 Dec 2010
- Last updated
- 29 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Red Wine Project: a Study of Ageing Indexes and Prevalence of Atherosclerosis in Regular Red Wine Consumers Versus Abstainers
- ClinicalTrials.gov ID
- NCT01268254
- Acronym / sponsor ID
- 1-48200805
- Conditions
- Coronary Disease
- Keywords
- wine, aging, atherosclerosis, telomere, tomography, coronary vessels
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 29 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| red wine | – | –red wine usual consumer versus abstemious |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- male subjects, between 50 years-old and 70 years-old, divided in 2 groups: usual red wine consumers and red wine abstemious
Key inclusion criteria (1 listed)
- healthy male, from 50 years-old to 70 years-old.
Key exclusion criteria (1 listed)
- asiatic or with manifest atherosclerosis disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Protasio L Da Luz, MD, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2010.