Gut Microbial Metabolites of Apple Polyphenols

Not Applicable

Recruiting

• Conditions: Healthy; Controlled Feeding Trial
• Interventions: Other: Dietary intervention - apple catechin diet; Other: Dietary intervention - low catechin diet

• Registration Number: NCT06107192
• Lead Sponsor: University of Maryland, College Park

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 differences in gut bacteria across individuals influence metabolism of polyphenols from foods, which may influence health benefits that people receive from different foods.

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 metabolite that is produced following consumption of a soy food: 15 O-desmethylangolensin (ODMA) producers and 15 age and gender-matched ODMA non-producers will be included. Participants will be assigned to consume two diets in random order: an apple catechin diet that provides a controlled amount of catechins in apple juice, and a nutritionally-matched low catechin diet. Both diet phases will last 3 days, with a 10 day washout period in between the two diet phases.

Study Timeline

• Study First Submitted: 2023-10-24
• Study First Submitted QC: 2023-10-24
• Study First Posted: 2023-10-30
• Study Start: 2023-12-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Completion of informed consent.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Any gender identification, aged 18 - 45.
4. BMI 18.5 - 40 kg/m^2
5. Ability to consume the intervention foods and beverages and be willing to adhere to the dietary regimen.
6. Agreement to provide urine and fecal samples according to the study protocol.
7. Agreement to adhere to avoid high catechin foods (tea, chocolate) for 4 weeks.
8. Able to come to the study location for 8 visits according to the study schedule.
9. 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.

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Exclusion Criteria

1. Current, regular use of antacids or acid reducers.
2. Systemic antibiotic use within the past month prior to the urinary screening until completion of the dietary intervention.
3. Pregnancy or lactation, within 3 months post-partum (regardless of breastfeeding) at screening or planning to become pregnant during the study duration.
4. 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.
5. Current diagnosis of renal, hepatic, or gastrointestinal conditions.
6. History of stroke.
7. Underweight (BMI <18.5 kg/m^2) or severe obesity (BMI >40 kg/m^2).
8. Under 18 years or above 45 years of age.
9. Unwilling or unable to participate in the controlled dietary intervention or provide urine or fecal samples.
10. Has a pacemaker, implanted defibrillator, or other implanted electronic device.
11. Change of body weight >10% between screening and dietary intervention.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Apple catechin	Dietary intervention - apple catechin diet	A 3-day controlled diet
Low catechin	Dietary intervention - low catechin diet	A 3-day controlled diet

Primary Outcome Measures

Name	Time	Method
Mean sum catechin metabolites	Post 3-day intervention vs. post 3-day control	Mean difference in sum catechin metabolite concentration in response to the intervention, stratified by ODMA producers and non-producers.

Secondary Outcome Measures

Name	Time	Method
Differences in microbiome profiles	Post 3-day intervention vs. post 3-day control	Differences in microbiome profiles in response to the 3-day intervention.
Mean individual catechin metabolites	Post 3-day intervention vs. post 3-day control	Mean differences in individual valerolactone and valeric acid concentrations in response to the intervention, stratified by ODMA producers and non-producers.
Difference in microbiome diversity	Post 3-day intervention vs. post 3-day control	Differences in microbiome diversity in response to the 3-day intervention.
Difference in microbial species abundance	Post 3-day intervention vs. post 3-day control	Differences in microbial species abundance in response to the 3-day intervention.

Trial Locations

Locations (1)

Department of Nutrition and Food Science; 🇺🇸 College Park, Maryland, United States