RecruitingNCT06810635

Polyphenol Metabotypes in People With Diabetes Type 2

Sponsor

University Hospital, Ghent

Enrollment

100 participants

Start Date

Mar 4, 2026

Study Type

OBSERVATIONAL

Conditions

Type 2 Diabetes Mellitus (T2DM)

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).

Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying 24 hours urine collection, Fasting urine collection, and others for people with type 2 diabetes mellitus (t2dm). The study is currently recruiting participants at 2 locations. People eligible for this study include aged 40 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTOral 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_TESTfasting blood sample

Fasting blood sample will be obtained for determination of markers of metabolic health.

DIAGNOSTIC_TESTFasting 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_TEST24 hours urine collection

Subjects collect urine over the entire 24h. for determination of polyphenol metabolites

OTHERQuestionnaires

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_TESTStool collection

Optional: some subjects collect stool samples to test the capacity of the microbiome to degrade polyphenols with a batch experiment.

DIAGNOSTIC_TESTTransit 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.