[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578387":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":38,"armGroups":39,"interventions":55,"overallOfficials":86,"centralContacts":90,"locations":99,"responsibleParty":123,"collaborators":125,"id":132,"slug":34,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":138,"sex":139,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":34,"studyType":145,"phases":34,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":119,"whyStopped":34,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18,22,25,28,31],{"measure":15,"description":16,"timeFrame":17},"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.",{"measure":19,"description":20,"timeFrame":21},"Transit time","Along with the ingestion of the polyphenol pill, people will consume E133, a food colorant that will also color the stool.","baseline",{"measure":23,"description":24,"timeFrame":21},"the capacity of the gut microbiome to degrade polyphenols","By using a batch experiment.",{"measure":26,"description":27,"timeFrame":21},"Metabolic health","This will be determined on the fasting blood samples",{"measure":29,"description":30,"timeFrame":21},"lifestyle factors and medical history (A)","physical activity, using the validated IPAQ questionnaire",{"measure":32,"description":33,"timeFrame":21},"lifestyle factors and medical history (B)","Sleep, using the validated PSQI questionnaire",null,{"allocation":34,"interventionModel":34,"interventionModelDescription":34,"primaryPurpose":34,"observationalModel":36,"timePerspective":37,"maskingInfo":34},"CASE_CONTROL","CROSS_SECTIONAL","Flemish T2DM patients and controls from Ghent region.",[40,51],{"label":41,"type":34,"description":42,"interventionNames":43},"T2DM","persons with type 2 diabetes mellitus",[44,45,46,47,48,49,50],"Dietary Supplement: Oral Polyphenol Challenge Test \u002F 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",{"label":52,"type":34,"description":53,"interventionNames":54},"Non diabetic persons","This cohort is a group without type 2 diabetes or any other chronic illness",[44,45,46,47,48,49,50],[56,61,66,70,74,78,82],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":34},"DIETARY_SUPPLEMENT","Oral Polyphenol Challenge Test \u002F PPPIL","Patients will receive a so-called oral polyphenol challenge test. It is a pill containing a multitude of polyphenol classes (doi: 10.1093\u002Fcdn\u002Fnzac072.020)",[52,41],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":34},"DIAGNOSTIC_TEST","fasting blood sample","Fasting blood sample will be obtained for determination of markers of metabolic health.",[52,41],{"type":62,"name":67,"description":68,"armGroupLabels":69,"otherNames":34},"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",[52,41],{"type":62,"name":71,"description":72,"armGroupLabels":73,"otherNames":34},"24 hours urine collection","Subjects collect urine over the entire 24h. for determination of polyphenol metabolites",[52,41],{"type":6,"name":75,"description":76,"armGroupLabels":77,"otherNames":34},"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.",[52,41],{"type":62,"name":79,"description":80,"armGroupLabels":81,"otherNames":34},"Stool collection","Optional: some subjects collect stool samples to test the capacity of the microbiome to degrade polyphenols with a batch experiment.",[52,41],{"type":62,"name":83,"description":84,"armGroupLabels":85,"otherNames":34},"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.",[52,41],[87],{"name":88,"affiliation":5,"role":89},"Bruno Lapauw, Professor","PRINCIPAL_INVESTIGATOR",[91,96],{"name":92,"role":93,"phone":94,"phoneExt":34,"email":95},"Jan Stautemas, PhD","CONTACT","003293328967","jan.stautemas@ugent.be",{"name":97,"role":93,"phone":34,"phoneExt":34,"email":98},"Patrick Calders, Professor","patrick.calders@ugent.be",[100,117],{"facility":101,"status":102,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":114},"Ghent University","NOT_YET_RECRUITING","Ghent","East Flanders","9000","Belgium","BE",{"type":109,"coordinates":110},"Point",[111,112],3.71667,51.05,{"lat":112,"lon":111},[115],{"name":116,"role":93,"phone":34,"phoneExt":34,"email":95},"Jan Stautemas",{"facility":118,"status":119,"city":103,"state":34,"zip":34,"country":106,"countryCode":107,"cosmosGeoPoint":120,"geoPoint":122,"contacts":34},"Department of rehabilitation sciences - UGent","RECRUITING",{"type":109,"coordinates":121},[111,112],{"lat":112,"lon":111},{"type":124,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[126,128,130],{"name":127,"class":6},"University Ghent",{"name":129,"class":6},"University of Parma",{"name":131,"class":6},"Universiteit Antwerpen","100578387",false,"NCT06810635","Polyphenol Metabotypes in People With Diabetes Type 2","PPPIL","Inclusion Criteria:\n\n* all participants\n* between 40-85 years\n* age-matched individuals without diabetes\n* BMI between 18.5-30\n* no metabolic syndrome\n* persons with T2DM\n* at leats 2 years of clinical diagnoses of T2DM\n* stable medication use for at least 1 month\n\nExclusion Criteria:\n\n* pregnancy of breastfeeding\n* in last month\n* acute use of anti\u002Fpre\u002Fprobiotics\n* start of new drug or dietary supplements\n* major changes in diet\n* major lifestyle changes\n* diseases\n* Gastrointestinal diseases (inflammatory bowel disease)\n* Bariatric surgery\n* Other forms of diabetes (cystic fibrosis\u002FMODY\u002FT1DM)\n* Heart problems (NYHA 3\u002F4) or previous cardiovascular events\n* Liver problems: non-alcohol steatohepatitis (NASH) and cirrhosis\n* Lung problems (COPD - GOLD 3\u002F4), cystic fibrosis\n* Uncontrolled thyroid function disruption in the past 6 months\n* Intake of coumarin derivatives and direct oral anticoagulant medication\n* Anti-cancer treatment: chemo-\u002Fimmunotherapy\n* Immonosuppressants (transplant)\n* Antiepileptic drugs",true,"ALL","40 Years","85 Years",{"count":143,"type":144},100,"ESTIMATED","OBSERVATIONAL","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).",[148],"Type 2 Diabetes Mellitus (T2DM)",[150,151],"polyphenol","transit time","2026-03-19",{"date":154,"type":155},"2026-03-23","ACTUAL",{"date":157,"type":155},"2026-03-04",{"date":159,"type":144},"2028-12",{"name":5,"class":6},2]