Status:
COMPLETED
Gut Microbial Metabolites of Apple Polyphenols
Lead Sponsor:
University of Maryland, College Park
Collaborating Sponsors:
MaineHealth
University of Hawaii Cancer Research Center
Conditions:
Healthy
Controlled Feeding Trial
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief 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 differenc...
Detailed Description
This is a randomized, cross-over controlled feeding trial. Thirty healthy adult volunteers will be selected to participate on the basis of urinary screening results measuring a gut bacterial metabolit...
Eligibility Criteria
Inclusion
- 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.
- Able to come to the study location for 8 visits according to the study schedule.
- As assessed through an initial urine screening phase, a person is eligible either on the basis of (1) the presence of a urinary marker for soy isoflavone metabolism (ODMA), or (2) as a control matched for age and gender.
Exclusion
- 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).
- Under 18 years or above 45 years of age.
- Unwilling or unable to participate in the controlled dietary intervention or provide urine or fecal samples.
- Has a pacemaker, implanted defibrillator, or other implanted electronic device.
- Change of body weight \>10% between screening and dietary intervention.
Key Trial Info
Start Date :
December 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06107192
Start Date
December 7 2023
End Date
May 8 2025
Last Update
June 22 2025
Active Locations (1)
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1
Department of Nutrition and Food Science
College Park, Maryland, United States, 20742