Polyphenol Metabotypes in People With Diabetes Type 2

NCT06810635 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-03-23

No results posted yet for this study

Summary

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).

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

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.

Sponsors & Collaborators

  • University Ghent

    collaborator OTHER
  • University of Parma

    collaborator OTHER
  • Universiteit Antwerpen

    collaborator OTHER
  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Bruno Lapauw, Professor · University Hospital, Ghent

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-04
Primary Completion
2028-11-30
Completion
2028-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06810635 on ClinicalTrials.gov