About this trial
Previous studies suggest that both RW and red grape juice (RGJ) have beneficial properties upon risk factors and cardiovascular events. However, the effects of grape polyphenols on metabolomics in men are still poorly understood. Recent advances in mass spectroscopy allowed substantial advances in the analysis of molecular signatures of several diseases.
Therefore, the objective of this study is to evaluate the impact of RGJ on plasma metabolomics in patients with chronic coronary disease (CAD). This is a crossover, prospective, randomized and controlled study, with two 3-week interventions: 1. daily consumption of RGJ (400 mL) and 2. total abstention from foods rich in polyphenols. Plasma metabolomics will be performed by gas chromatography (GC)/mass spectroscopy (MS) by (Prof. Labate, Department of Plant Genetics, ESALQ). The sample will consist of 50 patients with chronic CAD. aged between 46 and 69 years. The inclusion and exclusion criteria were defined to achieve homogeneity of the group and avoid interference. The central hypothesis of this study is that RGJ will exert effects upon pathways involved in lipids, carbohidrates and energy production, contributing to the understanding of the mechanisms of action of polyphenols on cardiovascular health, without the risks associated with alcohol.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 46 and 69 years.
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);
Disqualifiers
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.
Thrombocytopenia;
Trial design
Crossover
Treatments tested in this trial
Red Grape Juice
Other interventionParticipants will undergo two 3-week intervention periods in random order: daily consumption of 400 mL of red grape juice and a control period involving complete abstinence from polyphenol-rich foods.
Treatment groups
Trial outcomes
Primary outcomes
Plasma Metabolomics Changes
Change in plasma metabolomic profile after red grape juice consumption compared with the abstinence period.
Sponsors and contacts
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University of Sao Paulo General Hospital
Lead sponsor
InCor Heart Institute
Sponsor institution