Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2025-01-31
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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T2DM
persons with type 2 diabetes mellitus
Oral Polyphenol Challenge Test / PPPIL
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
Fasting blood sample will be obtained for determination of markers of metabolic health.
Fasting urine collection
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
Subjects collect urine over the entire 24h. for determination of polyphenol metabolites
Questionnaires
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
Optional: some subjects collect stool samples to test the capacity of the microbiome to degrade polyphenols with a batch experiment.
Transit time determination
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 persons
This cohort is a group without type 2 diabetes or any other chronic illness
Oral Polyphenol Challenge Test / PPPIL
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
Fasting blood sample will be obtained for determination of markers of metabolic health.
Fasting urine collection
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
Subjects collect urine over the entire 24h. for determination of polyphenol metabolites
Questionnaires
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
Optional: some subjects collect stool samples to test the capacity of the microbiome to degrade polyphenols with a batch experiment.
Transit time determination
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.
Interventions
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Oral Polyphenol Challenge Test / PPPIL
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
Fasting blood sample will be obtained for determination of markers of metabolic health.
Fasting urine collection
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
Subjects collect urine over the entire 24h. for determination of polyphenol metabolites
Questionnaires
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
Optional: some subjects collect stool samples to test the capacity of the microbiome to degrade polyphenols with a batch experiment.
Transit time determination
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
85 Years
ALL
Yes
Sponsors
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University Ghent
OTHER
University of Parma
OTHER
Universiteit Antwerpen
OTHER
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Bruno Lapauw, Professor
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Ghent University
Ghent, East Flanders, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ONZ-2023-0601
Identifier Type: -
Identifier Source: org_study_id
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