Gut Microbial Metabolites of Apple Polyphenols

Healthy Clinical Trial

— GutMMAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06107192
• Other study ID #: 2023-05787
• Secondary ID: 2022-67017-41032
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2023
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: University of Maryland, College Park
• Contact: Margaret Slavin, PhD
• Phone: 301-405-4533
• Email: mms[@]umd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Dietary intervention - apple catechin diet
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
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.

Locations

Country	Name	City	State
United States	Department of Nutrition and Food Science	College Park	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, College Park	MaineHealth, University of Hawaii Cancer Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean sum catechin metabolites	Mean difference in sum catechin metabolite concentration in response to the intervention, stratified by ODMA producers and non-producers.	Post 3-day intervention vs. post 3-day control
Secondary	Mean individual catechin metabolites	Mean differences in individual valerolactone and valeric acid concentrations in response to the intervention, stratified by ODMA producers and non-producers.	Post 3-day intervention vs. post 3-day control
Secondary	Differences in microbiome profiles	Differences in microbiome profiles in response to the 3-day intervention.	Post 3-day intervention vs. post 3-day control
Secondary	Difference in microbiome diversity	Differences in microbiome diversity in response to the 3-day intervention.	Post 3-day intervention vs. post 3-day control
Secondary	Difference in microbial species abundance	Differences in microbial species abundance in response to the 3-day intervention.	Post 3-day intervention vs. post 3-day control