Gut Microbial Metabolites of Apple Polyphenols

Completed · Not applicable

Conditions studied: Healthy, Controlled Feeding Trial

In brief

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.

Key facts

Study ID

NCT06107192

Run by

University of Maryland, College Park

People needed

32

Starts

2023-12-07

Expected to finish

2025-05-08

Last updated by the study team

2025-06-22

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Department of Nutrition and Food Science — College Park, Maryland, United States

Full record on ClinicalTrials.gov

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