[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578387":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":55,"centralContacts":59,"locations":68,"responsibleParty":92,"collaborators":94,"id":101,"slug":10,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":10,"studyType":114,"phases":10,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":88,"whyStopped":10,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",[8,20],{"label":9,"type":10,"description":11,"interventionNames":12},"T2DM",null,"persons with type 2 diabetes mellitus",[13,14,15,16,17,18,19],"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":21,"type":10,"description":22,"interventionNames":23},"Non diabetic persons","This cohort is a group without type 2 diabetes or any other chronic illness",[13,14,15,16,17,18,19],[25,30,35,39,43,47,51],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"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)",[21,9],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"DIAGNOSTIC_TEST","fasting blood sample","Fasting blood sample will be obtained for determination of markers of metabolic health.",[21,9],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"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",[21,9],{"type":31,"name":40,"description":41,"armGroupLabels":42,"otherNames":10},"24 hours urine collection","Subjects collect urine over the entire 24h. for determination of polyphenol metabolites",[21,9],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":10},"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.",[21,9],{"type":31,"name":48,"description":49,"armGroupLabels":50,"otherNames":10},"Stool collection","Optional: some subjects collect stool samples to test the capacity of the microbiome to degrade polyphenols with a batch experiment.",[21,9],{"type":31,"name":52,"description":53,"armGroupLabels":54,"otherNames":10},"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.",[21,9],[56],{"name":57,"affiliation":5,"role":58},"Bruno Lapauw, Professor","PRINCIPAL_INVESTIGATOR",[60,65],{"name":61,"role":62,"phone":63,"phoneExt":10,"email":64},"Jan Stautemas, PhD","CONTACT","003293328967","jan.stautemas@ugent.be",{"name":66,"role":62,"phone":10,"phoneExt":10,"email":67},"Patrick Calders, Professor","patrick.calders@ugent.be",[69,86],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Ghent University","NOT_YET_RECRUITING","Ghent","East Flanders","9000","Belgium","BE",{"type":78,"coordinates":79},"Point",[80,81],3.71667,51.05,{"lat":81,"lon":80},[84],{"name":85,"role":62,"phone":10,"phoneExt":10,"email":64},"Jan Stautemas",{"facility":87,"status":88,"city":72,"state":10,"zip":10,"country":75,"countryCode":76,"cosmosGeoPoint":89,"geoPoint":91,"contacts":10},"Department of rehabilitation sciences - UGent","RECRUITING",{"type":78,"coordinates":90},[80,81],{"lat":81,"lon":80},{"type":93,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[95,97,99],{"name":96,"class":6},"University Ghent",{"name":98,"class":6},"University of Parma",{"name":100,"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":112,"type":113},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).",[117],"Type 2 Diabetes Mellitus (T2DM)",[119,120],"polyphenol","transit time","2026-03-19",{"date":123,"type":124},"2026-03-23","ACTUAL",{"date":126,"type":124},"2026-03-04",{"date":128,"type":113},"2028-12",{"name":5,"class":6},2]