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Gut Microbial Metabolites of Apple Polyphenols

Conditions

Healthy Controlled Feeding Trial Gut microbiome Flavonoids Isoflavones Catechin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-07

Study Completion:2025-05-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06107192

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Margaret Slavin, PhD

PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Study Locations (Sites)

Department of Nutrition and Food Science

College Park, Maryland, 20742

United States

Collaborators and Investigators

Sponsor: University of Maryland, College Park

Margaret Slavin, PhD, PRINCIPAL_INVESTIGATOR, University of Maryland, College Park

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-07

Study Completion Date2025-05-08

Study Record Updates

Study Start Date2023-12-07

Study Completion Date2025-05-08

Terms related to this study

Keywords Provided by Researchers

Gut microbiome
Flavonoids
Isoflavones
Catechin

Additional Relevant MeSH Terms

Healthy
Controlled Feeding Trial