Understanding how gut bacteria metabolize apple polyphenols

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

This study is testing how healthy people's gut bacteria process apple compounds to see if it makes a difference in their health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: University of Maryland, College Park (Academic / other)
• Locations: 1 site (College Park, Maryland)
• Trial ID: NCT06107192 on ClinicalTrials.gov

What this trial studies

This controlled feeding trial aims to investigate the metabolism of polyphenols, specifically catechins from apples, by the gut microbiome. Thirty healthy adult volunteers will be selected based on their ability to produce a specific gut bacterial metabolite after consuming soy foods. Participants will follow two different diets in a randomized order: one rich in apple catechins and another low in catechins, with a washout period in between. The study will analyze how individual differences in gut bacteria affect the metabolism of these compounds and their potential health benefits.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 45 with a BMI between 18.5 and 40 kg/m² who can adhere to dietary restrictions.

Not a fit: Patients currently using antacids or antibiotics, or those with conditions affecting their gut microbiome, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of how dietary polyphenols impact health based on individual gut microbiome profiles.

How similar studies have performed: While studies on gut microbiome interactions with dietary components exist, this specific approach focusing on apple polyphenols is relatively novel.

Eligibility criteria

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.

Where this trial is running

College Park, Maryland

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

Study contacts

• Principal investigator: Margaret Slavin, PhD — University of Maryland, College Park
• Study coordinator: Margaret Slavin, PhD

Conditions Healthy; Controlled Feeding Trial; Gut microbiome; Flavonoids; Isoflavones; Catechin