Polyphenol metabolism patterns in people with type 2 diabetes
Polyphenol Metabotypes in People With Diabetes Type 2
This project will test whether people with type 2 diabetes process dietary polyphenols differently than age-matched people without diabetes by giving an oral polyphenol challenge and measuring blood, urine, gut transit, and microbial breakdown.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Ghent, East Flanders and 1 other locations) |
| Trial ID | NCT06810635 on ClinicalTrials.gov |
What this trial studies
This is a cross-sectional observational study comparing polyphenol metabotypes between adults with long-standing type 2 diabetes and age-matched individuals without diabetes. Participants undergo an oral polyphenol challenge, fasting blood draws, timed urine collections (including 24-hour urine), transit-time measurements, and questionnaires to capture diet and medication use. The study will compare metabolite profiles and link them to gut microbial capacity to degrade polyphenols and to intestinal transit time. Findings will be analyzed to identify factors that shape polyphenol metabotypes in people with and without T2DM.
Who should consider this trial
Good fit: Adults aged 40 to 85 with BMI 18.5–30 who either have type 2 diabetes diagnosed at least two years with stable medication use or are age-matched individuals without diabetes and without major comorbidities are ideal candidates.
Not a fit: People who are pregnant or breastfeeding, have recent use of antibiotics/prebiotics/probiotics, major gastrointestinal, liver, heart, lung, or immune-suppressing conditions, other forms of diabetes, or recent major diet or medication changes are unlikely to be eligible or to benefit from the protocol.
Why it matters
Potential benefit: If successful, this work could help personalize dietary or microbiome-targeted strategies to improve metabolic health in people with type 2 diabetes.
How similar studies have performed: Previous observational work has characterized polyphenol metabotypes and links to the gut microbiome, but translating these profiles into clinical interventions remains an early and developing area.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ghent, East Flanders and 1 other locations
- Ghent University — Ghent, East Flanders, Belgium (Not_yet_recruiting)
- Department of rehabilitation sciences - UGent — Ghent, Belgium (Recruiting)
Study contacts
- Principal investigator: Bruno Lapauw, Professor — University Hospital, Ghent
- Study coordinator: Jan Stautemas, PhD
- Email: jan.stautemas@ugent.be
- Phone: 003293328967
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.