Gut Microbial Metabolites of Apple Polyphenols (NCT06107192) | Clinical Trial Compass
CompletedNot Applicable
Gut Microbial Metabolites of Apple Polyphenols
United States32 participantsStarted 2023-12-07
Plain-language summary
The goal of this controlled feeding trial is to learn about the metabolism of polyphenols, a common class of compounds found in plant-based foods, by the gut microbiome. It will evaluate how differences in gut bacteria across individuals influence metabolism of polyphenols from foods, which may influence health benefits that people receive from different foods.
Who can participate
Age range
18 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
. Completion of informed consent.
. Stated willingness to comply with all study procedures and availability for the duration of the study.
. Any gender identification, aged 18 - 45.
. BMI 18.5 - 40 kg/m\^2
. Ability to consume the intervention foods and beverages and be willing to adhere to the dietary regimen.
. Agreement to provide urine and fecal samples according to the study protocol.
. Agreement to adhere to avoid high catechin foods (tea, chocolate) for 4 weeks.
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
Mean sum catechin metabolites
Timeframe: Post 3-day intervention vs. post 3-day control
. Able to come to the study location for 8 visits according to the study schedule.
Exclusion criteria
. Current, regular use of antacids or acid reducers.
. Systemic antibiotic use within the past month prior to the urinary screening until completion of the dietary intervention.
. Pregnancy or lactation, within 3 months post-partum (regardless of breastfeeding) at screening or planning to become pregnant during the study duration.
. Known allergic reactions to components of the foods or beverages of the study diet (soy, wheat, dairy, peanut, tree nuts, apples, eggs) or any history of anaphylactic food allergy.
. Current diagnosis of renal, hepatic, or gastrointestinal conditions.
. History of stroke.
. Underweight (BMI \<18.5 kg/m\^2) or severe obesity (BMI \>40 kg/m\^2).