Red grape juice and metabolism in men with coronary disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, crossover study in 50 men with chronic CAD. Each participant will undergo two 3-week periods in random order: daily 400 mL red grape juice and a polyphenol-free control diet, with plasma samples analyzed by GC-MS to profile metabolites. The study aims to identify metabolomic changes related to grape polyphenols and how they may relate to cardiovascular health. Eligibility emphasizes stable CAD, BMI below 30, and absence of significant symptoms or organ dysfunction. The research is conducted at the Instituto do Coração, University of São Paulo, with metabolomics analysis led by a collaborating lab.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age between 46 and 69 years.
* Established chronic coronary artery disease, defined by at least one of the following:
* Acute myocardial infarction occurring more than 30 days before enrollment;
* Angiographic evidence of ≥50% stenosis in one or more epicardial coronary arteries;
* Previous percutaneous coronary intervention (PCI);
* Previous coronary artery bypass grafting (CABG).
* BMI \<30 kg/m².
* Absence of:
* Angina symptoms;
* Dyspnea.

Exclusion Criteria:

* Use of antibiotics within 8 weeks before study enrollment.
* Heart failure, NYHA functional class ≥ II.
* Renal insufficiency, defined as creatinine clearance \<30 mL/min, calculated using the Cockcroft-Gault equation.
* Hepatic insufficiency, defined by:
* Thrombocytopenia;
* Reduced serum albumin;
* Prolonged prothrombin time.
* Cancer.
* Inflammatory bowel disease.
* Obstructive biliary disease.
* History of digestive tract surgery, including:
* Cholecystectomy;
* Gastrectomy;
* Colectomy.
* Diabetes mellitus.
* Use of antidiabetic medications.
* Hypertriglyceridemia.
* Use of illicit drugs.
* Habitual consumption of wine or other alcoholic beverages.
* Unstable angina.
* Moderate valvular heart disease.
* Chagas disease.
* Permanent pacemaker implantation.
* Chronic obstructive pulmonary disease (COPD).
* Aortic aneurysm.
* Aortic ectasia measuring \<40 mm.

Where it's running

• Incor - Instituto do Coração HCFMUSP
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Protásio Lemos da Luz
• Email: protasio.luz@incor.usp.br
• Phone: +55 (11) 2661-5952

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.