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Clinical Trials in Belgium / NCT06810635
Recruiting Observational

Polyphenol Metabotypes in People With Diabetes Type 2

NCT06810635 · tracked via the Priya Life Science Belgium tracker
Sponsor
University Hospital, Ghent
Phase
Observational
Started
2026-03-04
Last updated
2026-03-23

Condition(s) studied

Type 2 Diabetes Mellitus (T2DM)

Investigational drug(s) / intervention(s)

Oral Polyphenol Challenge Test / PPPILfasting blood sampleFasting urine collection24 hours urine collectionQuestionnairesStool collectionTransit time determination

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)

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

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

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

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.

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

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.

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).

Eligibility

Sex
ALL
Min age
40 Years
Max age
85 Years
Healthy volunteers
Accepted
Inclusion Criteria: * all participants * between 40-85 years * age-matched individuals without diabetes * BMI between 18.5-30 * no metabolic syndrome * persons with T2DM * at leats 2 years of clinical diagnoses of T2DM * stable medication use for at least 1 month Exclusion Criteria: * pregnancy of breastfeeding * in last month * acute use of anti/pre/probiotics * start of new drug or dietary supplements * major changes in diet * major lifestyle changes * diseases * Gastrointestinal diseases (inflammatory bowel disease) * Bariatric surgery * Other forms of diabetes (cystic fibrosis/MODY/T1DM) * Heart problems (NYHA 3/4) or previous cardiovascular events * Liver problems: non-alcohol steatohepatitis (NASH) and cirrhosis * Lung problems (COPD - GOLD 3/4), cystic fibrosis * Uncontrolled thyroid function disruption in the past 6 months * Intake of coumarin derivatives and direct oral anticoagulant medication * Anti-cancer treatment: chemo-/immunotherapy * Immonosuppressants (transplant) * Antiepileptic drugs

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Ghent University Ghent East Flanders Not Yet Recruiting
Department of rehabilitation sciences - UGent Ghent Belgium Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06810635 on ClinicalTrials.gov ↗ ← All trials in Belgium