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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

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 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

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
Intervention / Treatment
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

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

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

University Hospital, Ghent

Collaborators

University Ghent
Universiteit Antwerpen
University of Parma

Investigators

  • 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)

March 4, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

February 5, 2025

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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