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OpenTrials
Completed

NCT Number: NCT06107192

Gut Microbial Metabolites of Apple Polyphenols

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition and Food Science

College Park, Maryland, 20742, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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 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).
  • 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.

Treatment and study plan

Dietary intervention - apple catechin diet

Other

The intervention will provide a catechin-containing apple juice, for consumption alongside a low catechin diet tailored to participants calorie needs for weight maintenance.

Dietary intervention - low catechin diet

Other

The intervention will provide a nutritionally-matched beverage without catechins, for consumption alongside a low catechin diet tailored to participants calorie needs for weight maintenance.

Primary outcomes

  1. Mean sum catechin metabolites

    Time frame: 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 outcomes

  1. Mean individual catechin metabolites

    Time frame: 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.

  2. Differences in microbiome profiles

    Time frame: Post 3-day intervention vs. post 3-day control

    Differences in microbiome profiles in response to the 3-day intervention.

  3. Difference in microbiome diversity

    Time frame: Post 3-day intervention vs. post 3-day control

    Differences in microbiome diversity in response to the 3-day intervention.

  4. Difference in microbial species abundance

    Time frame: Post 3-day intervention vs. post 3-day control

    Differences in microbial species abundance in response to the 3-day intervention.

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Collaborators

  • MaineHealth
  • University of Hawaii Cancer Research Center

Registry information

Official study title

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

Acronym: GutMMAP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2023
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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