Type 2 Diabetes Mellitus (T2DM)PPPILNCT06810635
Polyphenol Metabotypes in People With Diabetes Type 2
An observational study of Type 2 Diabetes Mellitus (T2DM), run by University Hospital, Ghent at 2 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Oral Polyphenol Challenge Test / PPPIL, fasting blood sample and Fasting urine collection
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 2 sitesBelgium
- Study dates
- 4 Mar 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Flemish T2DM patients and controls from Ghent region.
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Patrick Calders, Professor contact
Belgium2 sites, 2 recruiting
- Not yet recruiting
Ghent University
Ghent, East Flanders, 9000
Jan Stautemas, jan.stautemas@ugent.be
- Recruiting
Department of rehabilitation sciences - UGent
Ghent
About this study
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).
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Oral Polyphenol Challenge Test / PPPIL, fasting blood sample, Fasting urine collection, 24 hours urine collection, Questionnaires
- Keywords
- polyphenol, transit time
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
fasting blood sampleDiagnostic test
Fasting blood sample will be obtained for determination of markers of metabolic health.
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
24 hours urine collectionDiagnostic test
Subjects collect urine over the entire 24h. for determination of polyphenol metabolites
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.
Stool collectionDiagnostic test
Optional: some subjects collect stool samples to test the capacity of the microbiome to degrade polyphenols with a batch experiment.
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.
| Study group | Role | What they receive |
|---|---|---|
| T2DM | persons with type 2 diabetes mellitus Receives: Dietary Supplement: Oral Polyphenol Challenge Test / PPPIL; Diagnostic Test: fasting blood sample; Diagnostic Test: Fasting urine collection; Diagnostic Test: 24 hours urine collection; Other: Questionnaires; Diagnostic Test: Stool collection; Diagnostic Test: Transit time determination | |
| Non diabetic persons | This cohort is a group without type 2 diabetes or any other chronic illness Receives: Dietary Supplement: Oral Polyphenol Challenge Test / PPPIL; Diagnostic Test: fasting blood sample; Diagnostic Test: Fasting urine collection; Diagnostic Test: 24 hours urine collection; Other: Questionnaires; Diagnostic Test: Stool collection; Diagnostic Test: Transit time determination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
For this purpose participants will collect urine over a 24h period
Measured: Urine will be collected over a 24h period after ingestion of the polyphenol pill.
Transit time
Along with the ingestion of the polyphenol pill, people will consume E133, a food colorant that will also color the stool.
Measured: baseline
the capacity of the gut microbiome to degrade polyphenols
By using a batch experiment.
Measured: baseline
Metabolic health
This will be determined on the fasting blood samples
Measured: baseline
lifestyle factors and medical history (A)
physical activity, using the validated IPAQ questionnaire
Measured: baseline
lifestyle factors and medical history (B)
Sleep, using the validated PSQI questionnaire
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start4 Mar 2026
- Primary completionNov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, University of Parma, Universiteit Antwerpen
- Responsible party
- Sponsor
- Investigators
- Bruno Lapauw, Professor, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810635
- Sponsor's protocol ID
- ONZ-2023-0601
- Acronym
- PPPIL
- Status last verified
- Mar 2026
- First submitted
- 6 Nov 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymous data will be made available on request after publication also to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyphenol Metabotypes in People With Diabetes Type 2
- ClinicalTrials.gov ID
- NCT06810635
- Acronym / sponsor ID
- PPPIL / ONZ-2023-0601
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- polyphenol, transit time
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent, University of Parma, Universiteit Antwerpen
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2DM | – | Dietary Supplement: Oral Polyphenol Challenge Test / PPPIL, Diagnostic Test: fasting blood sample, Diagnostic Test: Fasting urine collection, Diagnostic Test: 24 hours urine collection, Other: Questionnaires, Diagnostic Test: Stool collection, Diagnostic Test: Transit time determinationpersons with type 2 diabetes mellitus |
| Non diabetic persons | – | Dietary Supplement: Oral Polyphenol Challenge Test / PPPIL, Diagnostic Test: fasting blood sample, Diagnostic Test: Fasting urine collection, Diagnostic Test: 24 hours urine collection, Other: Questionnaires, Diagnostic Test: Stool collection, Diagnostic Test: Transit time determinationThis cohort is a group without type 2 diabetes or any other chronic illness |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Flemish T2DM patients and controls from Ghent region.
Key inclusion criteria (8 listed)
- all participants
- between 40-85 years
- age-matched individuals without diabetes
- BMI between 18.5-30
- no metabolic syndrome
Key exclusion criteria (18 listed)
- pregnancy of breastfeeding
- in last month
- acute use of anti/pre/probiotics
- start of new drug or dietary supplements
- major changes in diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Polyphenol Challenge Test / PPPILPatients 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) | Dietary supplement | Non diabetic persons, T2DM |
| fasting blood sampleFasting blood sample will be obtained for determination of markers of metabolic health. | Diagnostic test | Non diabetic persons, T2DM |
| Fasting urine collectionSubjects 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 | Diagnostic test | Non diabetic persons, T2DM |
| 24 hours urine collectionSubjects collect urine over the entire 24h. for determination of polyphenol metabolites | Diagnostic test | Non diabetic persons, T2DM |
| QuestionnairesQuestionnaires 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. | Other | Non diabetic persons, T2DM |
| Stool collectionOptional: some subjects collect stool samples to test the capacity of the microbiome to degrade polyphenols with a batch experiment. | Diagnostic test | Non diabetic persons, T2DM |
| Transit time determinationSubjects 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. | Diagnostic test | Non diabetic persons, T2DM |
Primary outcome
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.
6 secondary outcomes
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.
Transit time
Time frame: baseline
the capacity of the gut microbiome to degrade polyphenols
Time frame: baseline
Metabolic health
Time frame: baseline
lifestyle factors and medical history (A)
Time frame: baseline
lifestyle factors and medical history (B)
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Yes. All anonymous data will be made available on request after publication also to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Calders, Professor contact
Bruno Lapauw, Professor principal investigator
University Hospital, Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM), run by University Hospital, Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Stautemas, PhD (003293328967, jan.stautemas@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026; AzTrials last refreshed its copy on 1 Nov 2026.