Status:
COMPLETED
Red Wine Effects Upon Gut Flora and Plasma Levels of Trimethylamine-N-oxide (TMAO) - WineFlora Study
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
IBRAVIN
Conditions:
Trimethylamine-N-oxide
Gut Microbiota
Eligibility:
MALE
45-70 years
Phase:
NA
Brief Summary
Recent evidence indicates that Trimethylamine-N-oxide (TMAO) is a pro-atherosclerotic, phosphatidylcholine-dependent metabolite of diet and intestinal flora. Food substrates derive from carnitine and ...
Eligibility Criteria
Inclusion
- Men, 45-70 years
- Established atherosclerotic diseases defined as:
- A. Previous history of CAD: angina or acute myocardial infarction (AMI), myocardial revascularization or angioplasty, angiographic evidence of stenosis ≥50% in at least one of the major coronary arteries B. Cerebrovascular disease: transient ischemic stroke or cerebrovascular accident C. Peripheral arterial disease: clinical evidence of extracoronary atherosclerosis
Exclusion
- Acute events in the last 30 days (AMI, troponin elevation, coronary angioplasty or coronary artery bypass grafting)
- Heart Failure (NYHA functional class ≥ II)
- Renal Failure (clearance creatinine \<30 mL / min by the Cockcroft-Gault formula)
- Hepatic Failure
- Gastro-intestinal cancer
- Intestinal inflammatory diseases
- Obstructive biliary diseases
- Prior gastrointestinal surgeries: cholecystectomy or colectomy
- Use of antibiotics within the last 2 months or during protocol
- Alcoholism or alcohol intolerance
- Diabetes mellitus or use of antidiabetics drugs
Key Trial Info
Start Date :
August 31 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2018
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03232099
Start Date
August 31 2016
End Date
April 15 2018
Last Update
March 15 2021
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