[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554726":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":56,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Placebo vial (10ml of glycerol 10% and 10% maltrodextrin)",[13],"Dietary Supplement: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"D piger","EXPERIMENTAL","D. piger vial with 109 colony forming units (CFU) (=108 CFU D. piger per ml in 10ml of glycerol 10% and 10% maltrodextrin).",[19],"Dietary Supplement: D piger",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Probiotic d piger",[15],null,{"type":22,"name":9,"description":9,"armGroupLabels":27,"otherNames":25},[9],[29],{"name":30,"affiliation":31,"role":32},"Max Nieuwdorp, prof dr","Amsterdam UMC, location AMC","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"M Nieuwdorp, prof dr","CONTACT","020-5669111","m.nieuwdorp@amsterdamumc.nl",[40],{"facility":41,"status":42,"city":43,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Amsterdam UMC location AMC","RECRUITING","Amsterdam","Netherlands","NL",{"type":47,"coordinates":48},"Point",[49,50],4.88969,52.37403,{"lat":50,"lon":49},[53],{"name":54,"role":36,"phone":55,"phoneExt":25,"email":38},"max nieuwdorp, MD PhD","0031 20 5669111",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":60,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Max Nieuwdorp","Principal Investigator","Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC)","100554726","phase-1-effect-of-4-weeks-of-oral-d-piger-on-safety-pharmacokinetics-and-ethanol-metabolism-in-overweight-individuals-2023-100554726",false,"NCT06502834","Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)","PIGER","Inclusion:\n\nMale or (postmenopausal) females\n\n* Increased waist circumference (\\>102 cm men, 88\\>cm women)\n* Insulin resistance (HOMA\\>2.5)\n* 18-70 years\n\nExclusion Criteria:\n\n* Use of systemic medication (except for paracetamol), including antibiotics and pro-\u002Fprebiotics in the past three months or during the study period.\n* A history of a cardiovascular event\n* A history of cholecystectomy\n* Overt untreated gastrointestinal disease or abnormal bowel habits\n* Liver enzymes\\>2.5 fold higher than the upper limit of normal range\n* Smoking\n* Alcohol abuse","ALL","18 Years","70 Years",{"count":72,"type":73},20,"ESTIMATED","INTERVENTIONAL",[76],"PHASE1","The goal of the study is to determine the effect of supplementation of the d piger strain on intestinal ethanol production in individuals with overweight.\n\nThe investigators will perform a randomized trial in 2x10 participants to measure effects on ethanol in blood, and perform fecal analyses.",[79,80,81],"Obesity","Metabolic Syndrome","Steatosis of Liver","2024-07-15",{"date":84,"type":85},"2024-07-16","ACTUAL",{"date":87,"type":85},"2024-05-01",{"date":89,"type":73},"2024-12-01",{"name":58,"class":6},1]