[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466420":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":42,"centralContacts":47,"locations":53,"responsibleParty":73,"collaborators":75,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":32,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":32,"overallStatus":56,"whyStopped":32,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Max Planck Institute for Human Cognitive and Brain Sciences","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"prebiotic dietary supplement","ACTIVE_COMPARATOR","high-dose daily inulin",[13],"Dietary Supplement: Inulin",{"label":15,"type":16,"description":17,"interventionNames":18},"behavioural lifestyle intervention","EXPERIMENTAL","new educational program to change eating behaviour, provided through weekly sessions.",[19],"Behavioral: Lifestyle intervention",{"label":21,"type":22,"description":23,"interventionNames":24},"placebo dietary supplement","PLACEBO_COMPARATOR","equicaloric daily maltodextrin",[25],"Dietary Supplement: Placebo",[27,33,38],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIETARY_SUPPLEMENT","Inulin","28g\u002Fday delivered in 2 sachets throughout the day with main meals",[9],null,{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":32},"BEHAVIORAL","Lifestyle intervention","weekly educational sessions to improve individual's eating behaviour",[15],{"type":28,"name":39,"description":40,"armGroupLabels":41,"otherNames":32},"Placebo","equicaloric maltodextrin delivered in 2 sachets throughout the day with main meals",[21],[43],{"name":44,"affiliation":45,"role":46},"Veronica Witte, PhD","Cognitive Neurology, University Medical Center Leipzig","PRINCIPAL_INVESTIGATOR",[48],{"name":49,"role":50,"phone":51,"phoneExt":32,"email":52},"Meghedi Vartanian, MSc","CONTACT","+49(0)341\u002F9940-951","mi-food@cbs.mpg.de",[54],{"facility":55,"status":56,"city":57,"state":32,"zip":32,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences","RECRUITING","Leipzig","Germany","DE",{"type":61,"coordinates":62},"Point",[63,64],12.37129,51.33962,{"lat":64,"lon":63},[67,70,72],{"name":68,"role":50,"phone":69,"phoneExt":32,"email":52},"Meghedi Vartanian, Msc","+49(0)341\u002F9940-954",{"name":71,"role":50,"phone":69,"phoneExt":32,"email":52},"Silke Friedrich",{"name":44,"role":46,"phone":32,"phoneExt":32,"email":32},{"type":74,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[76,78,81],{"name":77,"class":6},"Universitätsklinikum Leipzig",{"name":79,"class":80},"DFG - Deutsche Forschungs Gemeinschaft (German Research Foundation)","UNKNOWN",{"name":82,"class":80},"Helmholtz-Zentrum für Umweltforschung - UFZ","100466420","impact-of-microbiome-changing-interventions-on-food-decision-making-100466420",false,"NCT05353504","Impact of Microbiome-changing Interventions on Food Decision-making","\"SFB 1052\u002F3 - Mechanismen Der Adipositas, Projekt A1: Veränderung Der Neurobiologischen Grundlagen Von Ess-Entscheidungen Bei Adipositas\" Engl. \"CRC 1052\u002F3 - Obesity Mechanisms, Project A1: Targeting Neurobehavioral Determinants of Obesity\"","MIFOOD","Inclusion Criteria:\n\n* BMI \\>= 25 kg\u002Fm2 or WHR \\>= 0.9\u002F0.85 (m\u002Fd, f)\n* no MRI contra-indication\n* written informed consent\n\nExclusion Criteria:\n\n* athletes\n* occurrence of a clinically relevant psychiatric disease in the last 12 months, e.g. depression, substance abuse, eating disorders, schizophrenia\n* any chronic inflammatory or malignant disease\n* type 1 diabetes\n* previous bariatric\u002Fgastric surgery\n* pregnancy or breastfeeding woman",true,"ALL","18 Years","60 Years",{"count":96,"type":97},90,"ESTIMATED","INTERVENTIONAL",[100],"NA","The investigators aim to test the hypothesis that a microbiome-changing dietary intervention improves food decision-making and to determine the underlying microbiotal and metabolic mechanisms. To this end, 90 overweight\u002Fobese adults will be enrolled in a randomized controlled trial to test the effects of a pre-biotic dietary intervention (supplementary intake of soluble fibre) or a behavioural lifestyle intervention (weekly educational program) vs. control condititon (supplementary intake of isocaloric starch) over a period of 26 weeks. Before and after the intervention\u002Fcontrol period, participants will undergo task-based functional and structural MRI and cognitive testing. The gut microbiota will be assessed using 16S rDNA next-generation sequencing (V3\u002FV4 region) in stool samples. Diet, anthropometry and lifestyle will be monitored with questionnaires and metabolomics will be assayed in peripheral blood and stool (e.g. SCFA). Using a modulation of gut-brain communication through a prebiotic diet and lifestyle intervention, respectively, the investigators will be able to discover microbiota communities that play a key role for eating behaviour. Related mechanistic insights could help to develop novel preventive and therapeutic options to combat unhealthy weight gain in our obesogenic society.",[103],"Overweight and Obesity","2022-04-26",{"date":106,"type":107},"2022-04-29","ACTUAL",{"date":109,"type":107},"2022-03-08",{"date":111,"type":97},"2026-12",{"name":5,"class":6},1]