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Study Evaluating the Effects of Red Grape Juice Consumption on Metabolism in Men With Coronary Artery Disease

Sponsor: University of Sao Paulo General Hospital • ClinicalTrials.gov ID: NCT07777341

Registry updated: 2026-08-28

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Description

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.

Interventions

Red Grape Juice (Other)
Participants 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.

Eligibility criteria

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.

Conditions

Coronary Arterial Disease (CAD)

Locations

Incor - Instituto do Coração HCFMUSP — São Paulo, São Paulo, Brazil

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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