NCT06810635

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Mar 2026Dec 2028

First Submitted

Initial submission to the registry

November 6, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 4, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

November 6, 2024

Last Update Submit

March 19, 2026

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

polyphenoltransit time

Outcome Measures

Primary Outcomes (1)

  • Differences in polyphenol metabolites in morning urine in persons with type 2 diabetes and in healthy controls.

    The study aims to characterize the overall polyphenol metabotype in patients with T2DM compared to age-matched individuals without diabetes. For this purpose we will look at morning urine 24h after ingestion of a polyphenol rich pill.

    This will be assessed the morning after ingestion of the pill containing polyphenols

Secondary Outcomes (6)

  • Differences in polyphenol metabolites in 24h urine in persons with type 2 diabetes and in healthy controls.

    Urine will be collected over a 24h period after ingestion of the polyphenol pill.

  • Transit time

    baseline

  • the capacity of the gut microbiome to degrade polyphenols

    baseline

  • Metabolic health

    baseline

  • lifestyle factors and medical history (A)

    baseline

  • +1 more secondary outcomes

Study Arms (2)

T2DM

persons with type 2 diabetes mellitus

Dietary Supplement: Oral Polyphenol Challenge Test / PPPILDiagnostic Test: fasting blood sampleDiagnostic Test: Fasting urine collectionDiagnostic Test: 24 hours urine collectionOther: QuestionnairesDiagnostic Test: Stool collectionDiagnostic Test: Transit time determination

Non diabetic persons

This cohort is a group without type 2 diabetes or any other chronic illness

Dietary Supplement: Oral Polyphenol Challenge Test / PPPILDiagnostic Test: fasting blood sampleDiagnostic Test: Fasting urine collectionDiagnostic Test: 24 hours urine collectionOther: QuestionnairesDiagnostic Test: Stool collectionDiagnostic Test: Transit time determination

Interventions

Oral Polyphenol Challenge Test / PPPILDIETARY_SUPPLEMENT

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)

Non diabetic personsT2DM
fasting blood sampleDIAGNOSTIC_TEST

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

Non diabetic personsT2DM
Fasting urine collectionDIAGNOSTIC_TEST

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

Non diabetic personsT2DM
24 hours urine collectionDIAGNOSTIC_TEST

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

Non diabetic personsT2DM
QuestionnairesOTHER

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.

Non diabetic personsT2DM
Stool collectionDIAGNOSTIC_TEST

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

Non diabetic personsT2DM
Transit time determinationDIAGNOSTIC_TEST

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.

Non diabetic personsT2DM

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Flemish T2DM patients and controls from Ghent region.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ghent University

Ghent, East Flanders, 9000, Belgium

NOT YET RECRUITING

Department of rehabilitation sciences - UGent

Ghent, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool Urine Plasma

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Urine Specimen CollectionSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Bruno Lapauw, Professor

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Stautemas, PhD

CONTACT

003293328967jan.stautemas@ugent.be

Patrick Calders, Professor

CONTACT

patrick.calders@ugent.be

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2024

First Posted

February 5, 2025

Study Start

March 4, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

All anonymous data will be made available on request after publication also to other researchers.

Locations

BE(2)