NCT07777341 Study Evaluating the Effects of Red Grape Juice Consumption on Metabolism in Men With Coronary Artery Disease
| NCT ID | NCT07777341 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Coronary Arterial Disease (CAD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-07-10 |
| Primary Completion | 2028-06-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-07-10 with a primary completion date of 2028-06-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Antonio Carlos Palandri Chagas
STUDY CHAIR
Incor - Instituto do Corção HCFMUSP
Frequently Asked Questions
Who can join the NCT07777341 clinical trial?
This trial is open to male participants only, aged 46 Years or older, up to 69 Years, studying Coronary Arterial Disease (CAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07777341 currently recruiting?
Yes, NCT07777341 is actively recruiting participants. Contact the research team at protasio.luz@incor.usp.br for enrollment information.
Where is the NCT07777341 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07777341 clinical trial?
NCT07777341 is sponsored by University of Sao Paulo General Hospital. The principal investigator is Antonio Carlos Palandri Chagas at Incor - Instituto do Corção HCFMUSP. The trial plans to enroll 50 participants.