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Apple Polyphenol Diet for Gut Health (GutMMAP Trial)

N/A

Recruiting

Led By Margaret Slavin, PhD

Research Sponsored by University of Maryland, College Park

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to come to the study location for 8 visits according to the study schedule

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post 3-day intervention vs. post 3-day control

Awards & highlights

GutMMAP Trial Summary

This trial measures how gut bacteria influence the health benefits that people get from plant-based foods. It looks at how gut bacteria break down polyphenols in foods.

Who is the study for?

This trial is for healthy individuals aged 18-45 with a BMI of 18.5-40 who can eat specific foods and avoid high catechin items like tea and chocolate for four weeks. Participants must be willing to provide urine and fecal samples, attend eight study visits, and adhere to the diet plan. Those with allergies to study foods, recent antibiotic use, pregnancy or lactation, or certain medical conditions cannot join.Check my eligibility

What is being tested?

The trial is testing how gut bacteria metabolize apple polyphenols by comparing two diets: one rich in apple catechins (natural compounds found in apples) versus a low-catechin diet. It aims to understand individual differences in processing these compounds which could affect health benefits from food.See study design

What are the potential side effects?

Since this is a dietary intervention involving commonly consumed foods (apples), significant side effects are not expected. However, participants may experience changes in digestion or allergic reactions if they have unknown sensitivities to components of the intervention diets.

GutMMAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can attend 8 visits at the study location as scheduled.

GutMMAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post 3-day intervention vs. post 3-day control

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post 3-day intervention vs. post 3-day control

This trial's timeline: 3 weeks for screening, Varies for treatment, and post 3-day intervention vs. post 3-day control for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean sum catechin metabolites

Secondary outcome measures

Difference in microbial species abundance

Difference in microbiome diversity

Differences in microbiome profiles

+1 more

GutMMAP Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Apple catechinExperimental Treatment1 Intervention

A 3-day controlled diet

Group II: Low catechinPlacebo Group1 Intervention

A 3-day controlled diet

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Hawaii Cancer Research CenterOTHER

9 Previous Clinical Trials

1,908 Total Patients Enrolled

University of Maryland, College ParkLead Sponsor

155 Previous Clinical Trials

45,635 Total Patients Enrolled

MaineHealthOTHER

71 Previous Clinical Trials

49,277 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project permit participants under 25 years old?

"This research endeavour is welcoming participants above the age of consent and below 45."

Answered by AI

Am I eligible to partake in this clinical trial?

"Admission to this trial is only granted to healthy individuals aged between 18 and 45. 30 people are expected to be enrolled in total."

Answered by AI

Are there any openings for participants in this clinical research project?

"The records on clinicaltrials.gov indicate that this particular trial is not presently seeking patients, as it has been inactive since October 24th of the current year. Nonetheless, there are 842 other studies actively recruiting participants in the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gut Microbial Metabolites of Apple Polyphenols

2024. "Gut Microbial Metabolites of Apple Polyphenols". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06107192.