NCT06810635

Polyphenol Metabotypes in People With Diabetes Type 2

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-03-04
• Primary completion: 2028-11-01
• Completion: 2028-12-01
• First posted: 2025-02-05
• Last updated: 2026-03-23

Locations

2 sites across 1 country: Belgium