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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age46-69
SponsorUniversity of Sao Paulo General Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age between 46 and 69 years.

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);

Disqualifiers

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.

Thrombocytopenia;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Red Grape Juice

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Red Juice/ AbstentionExperimental treatment 1 intervention
Group B: Abstention/ Red JuiceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Plasma Metabolomics Changes

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Sao Paulo General Hospital

Lead sponsor

InCor Heart Institute

Sponsor institution