Polyphenol Metabotypes in People with Diabetes Type 2

Not yet recruitingOBSERVATIONAL
Enrollment

100

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

November 30, 2028

Study Completion Date

December 31, 2028

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.

Trial Locations (1)

9000

Ghent University, Ghent

All Listed Sponsors
collaborator

University Ghent

OTHER

collaborator

University of Parma

OTHER

collaborator

Universiteit Antwerpen

OTHER

lead

University Hospital, Ghent

OTHER