Gut Microbial Metabolites of Apple Polyphenols

Last updated: May 20, 2024
Sponsor: University of Maryland, College Park
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Dietary intervention - apple catechin diet

Dietary intervention - low catechin diet

Clinical Study ID

NCT06107192
2023-05787
2022-67017-41032
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Completion of informed consent.

  2. Stated willingness to comply with all study procedures and availability for theduration 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 tothe 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 onthe 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

Exclusion Criteria:

  1. Current, regular use of antacids or acid reducers.

  2. Systemic antibiotic use within the past month prior to the urinary screening untilcompletion of the dietary intervention.

  3. Pregnancy or lactation, within 3 months post-partum (regardless of breastfeeding) atscreening 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 anaphylacticfood 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 provideurine 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.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Dietary intervention - apple catechin diet
Phase:
Study Start date:
December 07, 2023
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Department of Nutrition and Food Science

    College Park, Maryland 20742
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.