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

NCT07777341 | Recruiting

• 1 other identifier: 99203926.9.0000.0068
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Arterial Disease (CAD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Plasma Metabolomics Changes

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

  From enrollment to the end of treatment at 10 weeks

Study Arms (2)

Red Juice/ Abstention

EXPERIMENTAL

Group 1(Red Juice/ Abstention) will first consume 400 mL of red grape juice per day, five days per week, for three weeks, followed by a period of abstinence from polyphenol-rich foods.

Other: Red Grape Juice

Abstention/ Red Juice

EXPERIMENTAL

Group 2 (Abstention/ Red Juice) will follow the same interventions in the opposite order, beginning with the abstinence period and then consuming red grape juice.

Other: Red Grape Juice

Interventions

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.

Abstention/ Red Juice; Red Juice/ Abstention

Eligibility Criteria

• Age: 46 Years - 69 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Incor - Instituto do Coração HCFMUSP

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (1)

• Ghaedi E , Moradi S , Aslani Z , Kord-Varkaneh H , Miraghajani M , Mohammadi H . Effects of grape products on blood lipids: a systematic review and dose-response meta-analysis of randomized controlled trials. Food Funct. 2019 Oct 16;10(10):6399-6416. doi: 10.1039/c9fo01248f.

  PMID: 31517353 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Antonio Carlos Palandri Chagas

  Incor - Instituto do Corção HCFMUSP

  STUDY CHAIR

Central Study Contacts

Protásio Lemos da Luz

CONTACT

+55 (11) 2661-5952; protasio.luz@incor.usp.br

Michelle Aparecida Pereira Nistico

CONTACT

+55 (11) 2661-5952; michelle.pereira@incor.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): June 10, 2028
• Study Completion (Estimated): August 10, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)