Gut Microbial Metabolites of Apple Polyphenols (GutMMAP)

University of Maryland

Status: Completed

Conditions: Healthy; Controlled Feeding Trial

Treatments: Other: Dietary intervention - apple catechin diet; Other: Dietary intervention - low catechin diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06107192

2022-67017-41032 (Other Grant/Funding Number)

2023-05787

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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32 participants in 2 patient groups, including a placebo group

Apple catechin

Experimental group

Description:

A 3-day controlled diet

Treatment:

Other: Dietary intervention - apple catechin diet

Low catechin

Placebo Comparator group

Description:

A 3-day controlled diet

Treatment:

Other: Dietary intervention - low catechin diet