Polyphenol Metabotypes in People With Diabetes Type 2
University Hospital, Ghent
100 participants
Mar 4, 2026
OBSERVATIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria18
- 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
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Interventions
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 will be obtained for determination of markers of metabolic health.
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
Subjects collect urine over the entire 24h. for determination of polyphenol metabolites
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.
Optional: some subjects collect stool samples to test the capacity of the microbiome to degrade polyphenols with a batch experiment.
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06810635