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 range18 Years ā 45 Years
SexALL
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
ā. Completion of informed consent.
ā. Stated willingness to comply with all study procedures and availability for the duration of the study.
ā. Any gender identification, aged 18 - 45.
ā. BMI 18.5 - 40 kg/m\^2
ā. Ability to consume the intervention foods and beverages and be willing to adhere to the dietary regimen.
ā. Agreement to provide urine and fecal samples according to the study protocol.
ā. Agreement to adhere to avoid high catechin foods (tea, chocolate) for 4 weeks.
ā. Able to come to the study location for 8 visits according to the study schedule.
Exclusion criteria
ā. Current, regular use of antacids or acid reducers.
ā. Systemic antibiotic use within the past month prior to the urinary screening until completion of the dietary intervention.
ā. Pregnancy or lactation, within 3 months post-partum (regardless of breastfeeding) at screening or planning to become pregnant during the study duration.
ā. 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.
What they're measuring
1
Mean sum catechin metabolites
Timeframe: Post 3-day intervention vs. post 3-day control