Coronary Arterial Disease (CAD)GRAPEOMICSNCT07777341
Study Evaluating the Effects of Red Grape Juice Consumption on Metabolism in Men With Coronary Artery Disease
A study testing Red Grape Juice in people with Coronary Arterial Disease (CAD), run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 46 to 69 years, men only
- Conditions the study is for
- Coronary Arterial Disease (CAD)
- What is being tested?
- Red Grape Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jul 2026to 10 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 46 to 69 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- BMI <30 kg/m².
- Absence of:
- Angina symptoms;
- Dyspnea.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Incor - Instituto do Coração HCFMUSP
São Paulo, São Paulo, 05403-000
Michelle Aparecida Pareira Nistico, +55 (11) 2661-5952, michelle.pereira@incor.usp.br
Giovana Sisnandes dos Santos, giovana.sisnandes@hc.fm.usp.br
About this study
Official title: Effects of Red Grape Juice on the Plasma Metabolome in Chronic 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.
Read the 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.
- Conditions
- Coronary Arterial Disease (CAD)
- Being tested
- Red Grape Juice
- Keywords
- Coronary Artery Disease (CAD), Red Grape Juice, Metabolomics
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Grape JuiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Red Grape Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Metabolomics Changes
Change in plasma metabolomic profile after red grape juice consumption compared with the abstinence period.
Measured: From enrollment to the end of treatment at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start10 Jul 2026
- Primary completion10 Jun 2028 (estimated)
- Study completion10 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Protásio Lemos da Luz, InCor Heart Institute
- Investigators
- Antonio Carlos Palandri Chagas, Study chair, Incor - Instituto do Corção HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777341
- Sponsor's protocol ID
- 99203926.9.0000.0068
- Acronym
- GRAPEOMICS
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31517353
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Red Grape Juice on the Plasma Metabolome in Chronic Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT07777341
- Acronym / sponsor ID
- GRAPEOMICS / 99203926.9.0000.0068
- Conditions
- Coronary Arterial Disease (CAD)
- Keywords
- Coronary Artery Disease (CAD), Red Grape Juice, Metabolomics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 10 Jun 2028 (estimated)
- Study completion
- 10 Aug 2028 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red Juice/ Abstention | Experimental | Other: Red Grape JuiceGroup 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. |
| Abstention/ Red Juice | Experimental | Other: Red Grape JuiceGroup 2 (Abstention/ Red Juice) will follow the same interventions in the opposite order, beginning with the abstinence period and then consuming red grape juice. |
Who may qualify
- Ages
- 46 to 69 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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);
Key exclusion criteria (26 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red Grape JuiceParticipants 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. | Other | Abstention/ Red Juice, Red Juice/ Abstention |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Background: PubMed 31517353Ghaedi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio Carlos Palandri Chagas study chair
Incor - Instituto do Corção HCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Grape Juice in people with Coronary Arterial Disease (CAD), run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Protásio Lemos da Luz (+55 (11) 2661-5952, protasio.luz@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Metabolomics Changes (time frame: From enrollment to the end of treatment at 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07777341, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.