HealthyGutMMAPNCT06107192
Gut Microbial Metabolites of Apple Polyphenols
A study testing Dietary intervention - apple catechin diet and Dietary intervention - low catechin diet in people with Healthy and Controlled Feeding Trial, run by University of Maryland, College Park at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Controlled Feeding Trial
- What is being tested?
- Dietary intervention - apple catechin diet and Dietary intervention - low catechin diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2023to 8 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completion of informed consent.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Any gender identification, aged 18 - 45.
- BMI 18.5 - 40 kg/m^2
- Ability to consume the intervention foods and beverages and be willing to adhere to the dietary regimen.
- Agreement to provide urine and fecal samples according to the study protocol.
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- Agreement to adhere to avoid high catechin foods (tea, chocolate) for 4 weeks.
- Able to come to the study location for 8 visits according to the study schedule.
- 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.
Who cannot join
- Current, regular use of antacids or acid reducers.
- Systemic antibiotic use within the past month prior to the urinary screening until completion of the dietary intervention.
- Pregnancy or lactation, within 3 months post-partum (regardless of breastfeeding) at screening or planning to become pregnant during the study duration.
- 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.
- Current diagnosis of renal, hepatic, or gastrointestinal conditions.
- History of stroke.
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- Underweight (BMI <18.5 kg/m^2) or severe obesity (BMI >40 kg/m^2).
- Under 18 years or above 45 years of age.
- Unwilling or unable to participate in the controlled dietary intervention or provide urine or fecal samples.
- Has a pacemaker, implanted defibrillator, or other implanted electronic device.
- Change of body weight >10% between screening and dietary intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Nutrition and Food Science
College Park, Maryland, 20742
About this study
Official title: Gut Microbial Metabolites Of Apple Polyphenols: Interrogating Individual Differences To Establish Functional Biomarker Utility
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.
Read the detailed 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.
- Conditions
- Healthy, Controlled Feeding Trial
- Being tested
- Dietary intervention - apple catechin diet, Dietary intervention - low catechin diet
- Keywords
- Gut microbiome, Flavonoids, Isoflavones, Catechin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention - apple catechin dietOther
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 dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Apple catechin | Experimental | A 3-day controlled diet Receives: Other: Dietary intervention - apple catechin diet |
| Low catechin | Placebo comparator | A 3-day controlled diet Receives: Other: Dietary intervention - low catechin diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean sum catechin metabolites
Mean difference in sum catechin metabolite concentration in response to the intervention, stratified by ODMA producers and non-producers.
Measured: Post 3-day intervention vs. post 3-day control
Secondary outcomes (4)
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.
Measured: Post 3-day intervention vs. post 3-day control
Differences in microbiome profiles
Differences in microbiome profiles in response to the 3-day intervention.
Measured: Post 3-day intervention vs. post 3-day control
Difference in microbiome diversity
Differences in microbiome diversity in response to the 3-day intervention.
Measured: Post 3-day intervention vs. post 3-day control
Difference in microbial species abundance
Differences in microbial species abundance in response to the 3-day intervention.
Measured: Post 3-day intervention vs. post 3-day control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start7 Dec 2023
- Primary completion8 May 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- MaineHealth, University of Hawaii Cancer Research Center
- Responsible party
- Sponsor
- Investigators
- Margaret Slavin, PhD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107192
- Sponsor's protocol ID
- 2023-05787
- Other IDs
- 2022-67017-41032, 2023
- Acronym
- GutMMAP
- Status last verified
- Jun 2025
- First submitted
- 24 Oct 2023
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbial Metabolites Of Apple Polyphenols: Interrogating Individual Differences To Establish Functional Biomarker Utility
- ClinicalTrials.gov ID
- NCT06107192
- Acronym / sponsor ID
- GutMMAP / 2023-05787
- Conditions
- Healthy, Controlled Feeding Trial
- Keywords
- Gut microbiome, Flavonoids, Isoflavones, Catechin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- MaineHealth, University of Hawaii Cancer Research Center
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apple catechin | Experimental | Other: Dietary intervention - apple catechin dietA 3-day controlled diet |
| Low catechin | Placebo comparator | Other: Dietary intervention - low catechin dietA 3-day controlled diet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Completion of informed consent.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Any gender identification, aged 18 - 45.
- BMI 18.5 - 40 kg/m^2
- Ability to consume the intervention foods and beverages and be willing to adhere to the dietary regimen.
Key exclusion criteria (11 listed)
- Current, regular use of antacids or acid reducers.
- Systemic antibiotic use within the past month prior to the urinary screening until completion of the dietary intervention.
- Pregnancy or lactation, within 3 months post-partum (regardless of breastfeeding) at screening or planning to become pregnant during the study duration.
- 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.
- Current diagnosis of renal, hepatic, or gastrointestinal conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary intervention - apple catechin dietThe intervention will provide a catechin-containing apple juice, for consumption alongside a low catechin diet tailored to participants calorie needs for weight maintenance. | Other | Apple catechin |
| Dietary intervention - low catechin dietThe intervention will provide a nutritionally-matched beverage without catechins, for consumption alongside a low catechin diet tailored to participants calorie needs for weight maintenance. | Other | Low catechin |
Primary outcome
Mean sum catechin metabolites
Time frame: Post 3-day intervention vs. post 3-day control
Mean difference in sum catechin metabolite concentration in response to the intervention, stratified by ODMA producers and non-producers.
4 secondary outcomes
Mean individual catechin metabolites
Time frame: Post 3-day intervention vs. post 3-day control
Differences in microbiome profiles
Time frame: Post 3-day intervention vs. post 3-day control
Difference in microbiome diversity
Time frame: Post 3-day intervention vs. post 3-day control
Difference in microbial species abundance
Time frame: Post 3-day intervention vs. post 3-day control
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Slavin, PhD principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention - apple catechin diet and Dietary intervention - low catechin diet in people with Healthy and Controlled Feeding Trial, run by University of Maryland, College Park at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean sum catechin metabolites (time frame: Post 3-day intervention vs. post 3-day control). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.