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NCT Number: NCT07777341

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

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.

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Key information

Age range

49 year–69 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Incor - Instituto do Coração HCFMUSP

São Paulo, 05403-000, Brazil

Location status: Recruiting

Location contact

Antonio Carlos Chagas

SUB_INVESTIGATOR

Desiderio Favarato

SUB_INVESTIGATOR

Giovana Sisnandes dos Santos

CONTACT

[email protected]

Michelle Aparecida Pareira Nistico

CONTACT

[email protected]

+55 (11) 2661-5952

About this study

Previous studies have suggested that both red wine and red grape juice exert beneficial effects on cardiovascular health, including reductions in inflammatory biomarkers and cardiovascular events. However, the influence of grape polyphenols on the plasma metabolome in men with chronic coronary artery disease (CAD) remains poorly understood. Human plasma contains a wide range of metabolites that reflect physiological and pathological processes, making metabolomic profiling a valuable approach for investigating the biological effects of dietary interventions. Recent advances in mass spectrometry-based technologies have greatly expanded the ability to characterize these metabolic changes.

This prospective, randomized, controlled crossover study aims to investigate the effects of red grape juice consumption on the plasma metabolome of patients with chronic CAD. Fifty men aged 46 to 69 years with a confirmed diagnosis of chronic CAD will be enrolled. 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. Plasma metabolomic profiling will be performed using gas chromatography-mass spectrometry (GC-MS) by Prof. Carlos Labate at the Department of Genetics, Luiz de Queiroz College of Agriculture (ESALQ), University of São Paulo. Eligibility criteria were established to ensure a homogeneous study population and to minimize potential confounding factors. We hypothesize that red grape juice consumption will modulate metabolic pathways involved in lipid metabolism, carbohydrate metabolism, and energy production, providing further insight into the mechanisms by which grape polyphenols promote cardiovascular health without the risks associated with alcohol consumption.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Plasma Metabolomics Changes

    Time frame: From enrollment to the end of treatment at 10 weeks

    Change in plasma metabolomic profile after red grape juice consumption compared with the abstinence period.

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Aparecida Pereira Nistico

CONTACT

[email protected]

+55 (11) 2661-5952

Protásio Lemos da Luz

CONTACT

[email protected]

+55 (11) 2661-5952

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Acronym: GRAPEOMICS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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