NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

RecruitingNA

Sponsor: University of Sao Paulo General Hospital

Conditions: Coronary Arterial Disease (CAD)

Interventions: Red Grape Juice

Countries: Brazil

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 overview

Sex: MALE

Age: 49 Years to 69 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

Individuals aged 46 to 69 years with established chronic coronary artery disease diagnosed more than 30 days after acute myocardial infarction, angiographic evidence of ≥50% stenosis in one or more epicardial coronary arteries, previous percutaneous coronary intervention, or previous coronary artery bypass graft surgery, with a body mass index (BMI) \<30 kg/m² and without symptoms of angina or dyspnea.

Exclusion Criteria:

Exclusion criteria include the use of antibiotics within the eight weeks preceding study enrollment; heart failure (New York Heart Association functional class ≥II); renal insufficiency (creatinine clearance \<30 mL/min calculated using the Cockcroft-Gault equation); and hepatic insufficiency (defined by thrombocytopenia, reduced serum albumin, and prolonged prothrombin time). Individuals with cancer, inflammatory bowel disease, obstructive biliary disease, or a history of digestive surgery, including cholecystectomy, gastrectomy, or colectomy, will also be excluded. Patients with diabetes mellitus, those receiving antidiabetic medications, or those with hypertriglyceridemia will be excluded because of the high sugar content of red grape juice (400 mL contains approximately 280 kcal and 60 g of carbohydrates). The use of illicit drugs and habitual consumption of wine or other alcoholic beverages are also exclusion criteria. In addition, individuals with unstable angina, moderate valvular heart disease, Chagas disease, permanent pacemaker implantation, chronic obstructive pulmonary disease (COPD), aortic aneurysm, or aortic ectasia measuring less than 40 mm will be excluded.

Locations (1)

São Paulo, São Paulo, Brazil