Polyphenol Metabotypes in People With Diabetes Type 2 (PPPIL)

March 19, 2026 updated by: University Hospital, Ghent
This cross-sectional study seeks to characterize the overall polyphenol metabotype in patients with T2DM in comparison to age-matched individuals without diabetes. Additionally, the study aims to identify factors that influence the polyphenol metabotype (transit time and gut microbial capacity to degrade polyphenols in particular).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Ghent, Belgium
        • Recruiting
        • Department of rehabilitation sciences - UGent
    • East Flanders
      • Ghent, East Flanders, Belgium, 9000

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Flemish T2DM patients and controls from Ghent region.

Description

Inclusion Criteria:

  • all participants
  • between 40-85 years
  • age-matched individuals without diabetes
  • BMI between 18.5-30
  • no metabolic syndrome
  • persons with T2DM
  • at leats 2 years of clinical diagnoses of T2DM
  • stable medication use for at least 1 month

Exclusion Criteria:

  • pregnancy of breastfeeding
  • in last month
  • acute use of anti/pre/probiotics
  • start of new drug or dietary supplements
  • major changes in diet
  • major lifestyle changes
  • diseases
  • Gastrointestinal diseases (inflammatory bowel disease)
  • Bariatric surgery
  • Other forms of diabetes (cystic fibrosis/MODY/T1DM)
  • Heart problems (NYHA 3/4) or previous cardiovascular events
  • Liver problems: non-alcohol steatohepatitis (NASH) and cirrhosis
  • Lung problems (COPD - GOLD 3/4), cystic fibrosis
  • Uncontrolled thyroid function disruption in the past 6 months
  • Intake of coumarin derivatives and direct oral anticoagulant medication
  • Anti-cancer treatment: chemo-/immunotherapy
  • Immonosuppressants (transplant)
  • Antiepileptic drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
T2DM
persons with type 2 diabetes mellitus
Dietary supplement: Oral Polyphenol Challenge Test / PPPIL
Patients will receive a so-called oral polyphenol challenge test. It is a pill containing a multitude of polyphenol classes (doi: 10.1093/cdn/nzac072.020)
Diagnostic test: fasting blood sample
Fasting blood sample will be obtained for determination of markers of metabolic health.
Diagnostic test: Fasting urine collection
Subjects collect morning urine (or the urine thereafter ) in a separate urine container and write down the time of urine collection for determination of polyphenol metabolites
Diagnostic test: 24 hours urine collection
Subjects collect urine over the entire 24h. for determination of polyphenol metabolites
Other: Questionnaires
Questionnaires will be performed to collect information on lifestyle and baseline characteristics: physical activity (IPAQ), sleep (PSQI), drinking and smoking behaviour, drug intake and medical record.
Diagnostic test: Stool collection
Optional: some subjects collect stool samples to test the capacity of the microbiome to degrade polyphenols with a batch experiment.
Diagnostic test: Transit time determination
Subjects take a pill containing 90mg of royal blue dye (E133) together with the polyphenol pill to determine their transit time. When their stool discolours, the subjects notify the researcher.
Non diabetic persons
This cohort is a group without type 2 diabetes or any other chronic illness
Dietary supplement: Oral Polyphenol Challenge Test / PPPIL
Patients will receive a so-called oral polyphenol challenge test. It is a pill containing a multitude of polyphenol classes (doi: 10.1093/cdn/nzac072.020)
Diagnostic test: fasting blood sample
Fasting blood sample will be obtained for determination of markers of metabolic health.
Diagnostic test: Fasting urine collection
Subjects collect morning urine (or the urine thereafter ) in a separate urine container and write down the time of urine collection for determination of polyphenol metabolites
Diagnostic test: 24 hours urine collection
Subjects collect urine over the entire 24h. for determination of polyphenol metabolites
Other: Questionnaires
Questionnaires will be performed to collect information on lifestyle and baseline characteristics: physical activity (IPAQ), sleep (PSQI), drinking and smoking behaviour, drug intake and medical record.
Diagnostic test: Stool collection
Optional: some subjects collect stool samples to test the capacity of the microbiome to degrade polyphenols with a batch experiment.
Diagnostic test: Transit time determination
Subjects take a pill containing 90mg of royal blue dye (E133) together with the polyphenol pill to determine their transit time. When their stool discolours, the subjects notify the researcher.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Differences in polyphenol metabolites in morning urine in persons with type 2 diabetes and in healthy controls.
Time Frame: This will be assessed the morning after ingestion of the pill containing polyphenols
The study aims to characterize the overall polyphenol metabotype in patients with T2DM compared to age-matched individuals without diabetes. For this purpose we will look at morning urine 24h after ingestion of a polyphenol rich pill.
This will be assessed the morning after ingestion of the pill containing polyphenols

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Differences in polyphenol metabolites in 24h urine in persons with type 2 diabetes and in healthy controls.
Time Frame: Urine will be collected over a 24h period after ingestion of the polyphenol pill.
For this purpose participants will collect urine over a 24h period
Urine will be collected over a 24h period after ingestion of the polyphenol pill.
Transit time
Time Frame: baseline
Along with the ingestion of the polyphenol pill, people will consume E133, a food colorant that will also color the stool.
baseline
the capacity of the gut microbiome to degrade polyphenols
Time Frame: baseline
By using a batch experiment.
baseline
Metabolic health
Time Frame: baseline
This will be determined on the fasting blood samples
baseline
lifestyle factors and medical history (A)
Time Frame: baseline
physical activity, using the validated IPAQ questionnaire
baseline
lifestyle factors and medical history (B)
Time Frame: baseline
Sleep, using the validated PSQI questionnaire
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Ghent

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Ghent
Universiteit Antwerpen
University of Parma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bruno Lapauw, Professor, University Hospital, Ghent

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ONZ-2023-0601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All anonymous data will be made available on request after publication also to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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