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NCT Number: NCT06810635

Polyphenol Metabotypes in People With Diabetes Type 2

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).

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University, Ghent, East Flanders, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

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

  2. Transit time

    Time frame: baseline

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

  3. the capacity of the gut microbiome to degrade polyphenols

    Time frame: baseline

    By using a batch experiment.

  4. Metabolic health

    Time frame: baseline

    This will be determined on the fasting blood samples

  5. lifestyle factors and medical history (A)

    Time frame: baseline

    physical activity, using the validated IPAQ questionnaire

  6. lifestyle factors and medical history (B)

    Time frame: baseline

    Sleep, using the validated PSQI questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Stautemas, PhD

CONTACT

[email protected]

003293328967

Patrick Calders, Professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Universiteit Antwerpen
  • University Ghent
  • University of Parma

Registry information

Acronym: PPPIL

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 5, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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