Clinical Trials Directory

Trials / Completed

CompletedNCT06107192

Gut Microbial Metabolites of Apple Polyphenols

Gut Microbial Metabolites Of Apple Polyphenols: Interrogating Individual Differences To Establish Functional Biomarker Utility

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
University of Maryland, College Park · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERDietary intervention - apple catechin dietThe intervention will provide a catechin-containing apple juice, for consumption alongside a low catechin diet tailored to participants calorie needs for weight maintenance.
OTHERDietary intervention - low catechin dietThe intervention will provide a nutritionally-matched beverage without catechins, for consumption alongside a low catechin diet tailored to participants calorie needs for weight maintenance.

Timeline

Start date
2023-12-07
Primary completion
2025-05-08
Completion
2025-05-08
First posted
2023-10-30
Last updated
2025-06-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06107192. Inclusion in this directory is not an endorsement.