Polyphenol Metabotypes in People With Diabetes Type 2
NCT06810635 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2026-03-23
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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