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Polyphenol Metabotypes in People With Diabetes Type 2

ConditionType 2 Diabetes Mellitus (T2DM)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-85
SponsorUniversity Hospital, Ghent

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

all participants

between 40-85 years

age-matched individuals without diabetes

BMI between 18.5-30

Disqualifiers

pregnancy of breastfeeding

in last month

acute use of anti/pre/probiotics

start of new drug or dietary supplements

Trial population

Flemish T2DM patients and controls from Ghent region.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Oral Polyphenol Challenge Test / PPPIL

    Dietary 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)

  • fasting blood sample

    Diagnostic test

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

  • Fasting urine collection

    Diagnostic 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

  • 24 hours urine collection

    Diagnostic test

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

  • Questionnaires

    Other intervention

    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

    Diagnostic test

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

  • Transit time determination

    Diagnostic 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: T2DM7 interventions
Group B: Non diabetic persons7 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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

For this purpose participants will collect urine over a 24h period

Time frame
Urine will be collected over a 24h period after ingestion of the polyphenol pill.
2

Transit time

Along with the ingestion of the polyphenol pill, people will consume E133, a food colorant that will also color the stool.

Time frame
baseline
3

the capacity of the gut microbiome to degrade polyphenols

By using a batch experiment.

Time frame
baseline
4

Metabolic health

This will be determined on the fasting blood samples

Time frame
baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

University Ghent

Collaborator

University of Parma

Collaborator

Universiteit Antwerpen

Collaborator

Source ClinicalTrials.gov
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