Effects of Grape Consumption on the Immune-Gut Axis in Obesity (NCT07231484) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Grape Consumption on the Immune-Gut Axis in Obesity
United States50 participantsStarted 2025-12-19
Plain-language summary
This study is investigating the benefits of whole freeze-dried grape powder consumption on the immune-gut axis in adults with obesity.
Who can participate
Age range
30 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 30-45 years
* Obesity with BMI of 30-45 kg/m2
* Willingness to consume study foods
* Consistent diet and activity patterns for 4 weeks
* Weight stable (\<5kg change over last 3 months)
* Non-smoker \> 1 year or more
* Not currently consuming an extremely healthy diet
Exclusion Criteria:
* Study food allergies
* Regular consumption of grapes or grape-derived products
* Gastrointestinal disease and/or bariatric surgery
* Uncontrolled hypertension and blood pressure \>180/110
* Diabetes
* Clinical Depression
* Illicit drug use
* History of alcohol or drug abuse
* Recent use of medications that affect immune function (e.g., corticosteroids)
* Recent consumption of antibiotics, prebiotics, probiotics, symbiotics, or dietary supplements containing fiber or phytochemicals
* Pregnant or lactating individuals
* HIV positivity
* Recent start of medications that affect metabolism or appetite
* Drug therapy for coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gut microbial diversity
Timeframe: Baseline, Week 4, Week 8, Week 12
2
LPS-binding protein concentration
Timeframe: Baseline, Week 4, Week 8, Week 12
3
Cytokine concentrations following PBMC stimulation