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NCT07777341Recruiting

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

Effects of Red Grape Juice on the Plasma Metabolome in Chronic Coronary Artery Disease.

Source: ClinicalTrials.gov · Last updated 28 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
17 Aug 2026
Start date
10 Jul 2026
Primary completion date
10 Jun 2028
Lead sponsor
University of Sao Paulo General Hospital
NCT number
NCT07777341

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 10 Jul 2026 to the primary completion date, 10 Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of antibiotics within 8 weeks before study enrollment.
  • Use of antidiabetic medications.
  • Use of illicit drugs.

Other illness

  • Heart failure, NYHA functional class ≥ II.
  • Hepatic insufficiency, defined by:
  • Cancer.
  • Inflammatory bowel disease.
  • Obstructive biliary disease.
  • History of digestive tract surgery, including:
  • Diabetes mellitus.
  • Unstable angina.
  • Moderate valvular heart disease.
  • Chagas disease.
  • Chronic obstructive pulmonary disease (COPD).

Lab values

  • Renal insufficiency, defined as creatinine clearance \<30 mL/min, calculated using the Cockcroft-Gault equation.
  • Reduced serum albumin;

Other

  • Thrombocytopenia;
  • Prolonged prothrombin time.
  • Cholecystectomy;
  • Gastrectomy;
  • Colectomy.
  • Hypertriglyceridemia.
  • Habitual consumption of wine or other alcoholic beverages.
  • Permanent pacemaker implantation.
  • Aortic aneurysm.
  • Aortic ectasia measuring \<40 mm.

Who the study is looking for

  • 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.

Age in the registry: 46 years to 69 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Incor - Instituto do Coração HCFMUSP
Coordinator of this site? Confirm its status		São PauloBrazilRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.