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| Name | Class |
|---|---|
| University Ghent | OTHER |
| University of Parma | OTHER |
| Universiteit Antwerpen | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2DM | persons with type 2 diabetes mellitus |
| |
| Non diabetic persons | This cohort is a group without type 2 diabetes or any other chronic illness |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Urine will be collected over a 24h period after ingestion of the polyphenol pill. |
| Transit time |
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Inclusion Criteria:
Exclusion Criteria:
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Flemish T2DM patients and controls from Ghent region.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Stautemas, PhD | Contact | 003293328967 | jan.stautemas@ugent.be | |
| Patrick Calders, Professor | Contact | patrick.calders@ugent.be |
| Name | Affiliation | Role |
|---|---|---|
| Bruno Lapauw, Professor | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University | Not yet recruiting | Ghent | East Flanders | 9000 | Belgium |
All anonymous data will be made available on request after publication also to other researchers.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059349 | Urine Specimen Collection |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Stool Urine Plasma
| 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. |
|
Along with the ingestion of the polyphenol pill, people will consume E133, a food colorant that will also color the stool. |
| baseline |
| the capacity of the gut microbiome to degrade polyphenols | By using a batch experiment. | baseline |
| Metabolic health | This will be determined on the fasting blood samples | baseline |
| lifestyle factors and medical history (A) | physical activity, using the validated IPAQ questionnaire | baseline |
| lifestyle factors and medical history (B) | Sleep, using the validated PSQI questionnaire | baseline |
| Department of rehabilitation sciences - UGent | Recruiting | Ghent | Belgium |
| D004700 | Endocrine System Diseases |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |