Skip to content

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07777341
Acronym
GRAPEOMICS
Enrollment
50
Registered
2026-08-20
Start date
2026-07-10
Completion date
2028-08-10
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Arterial Disease (CAD)

Keywords

Coronary Artery Disease (CAD), Red Grape Juice, Metabolomics

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.

Detailed description

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.

Interventions

OTHERRed Grape Juice

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.

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
46 Years to 69 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Plasma Metabolomics ChangesFrom enrollment to the end of treatment at 10 weeksChange in plasma metabolomic profile after red grape juice consumption compared with the abstinence period.

Countries

Brazil

Contacts

CONTACTProtásio Lemos da Luz
protasio.luz@incor.usp.br+55 (11) 2661-5952
CONTACTMichelle Aparecida Pereira Nistico
michelle.pereira@incor.usp.br+55 (11) 2661-5952
STUDY_CHAIRAntonio Carlos Palandri Chagas

Incor - Instituto do Corção HCFMUSP

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026