An interventional study of Red Grape Juice in Coronary Arterial Disease (CAD), sponsored by University of Sao Paulo General Hospital. Recruiting at 1 site in Brazil. Open to male participants aged 46 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Basic science
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.
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 50 is below the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 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
Plan to share: No
Started Jul 2026 (actual). Primary completion is estimated for Jun 2028, 23 months after the start.
Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 23 months is below that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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