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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
Must not have
Current, regular use of antacids or acid reducers
Current diagnosis of renal, hepatic, or gastrointestinal conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post 3-day intervention vs. post 3-day control
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can attend 8 visits at the study location as scheduled.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I regularly use antacids or acid reducers.
Select...
I have a current diagnosis of kidney, liver, or gastrointestinal conditions.
Select...
I am either younger than 18 or older than 45.
Select...
I have had a stroke in the past.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean sum catechin metabolites
Secondary study objectives
Difference in microbial species abundance
Difference in microbiome diversity
Differences in microbiome profiles
+1 moreTrial 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
Find a Location
Who is running the clinical trial?
University of Hawaii Cancer Research CenterOTHER
10 Previous Clinical Trials
2,050 Total Patients Enrolled
University of Maryland, College ParkLead Sponsor
159 Previous Clinical Trials
46,433 Total Patients Enrolled
MaineHealthOTHER
74 Previous Clinical Trials
43,745 Total Patients Enrolled
Margaret Slavin, PhDPrincipal InvestigatorUniversity of Maryland, College Park