[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556664":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":67,"collaborators":25,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":25,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Purdue University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pure Inulin","EXPERIMENTAL","12 g\u002Fday prebiotic supplement",[13],"Other: Inulin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","6 g\u002Fday maltodextrin",[19],"Other: Maltodextrin",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Inulin","12 g\u002Fday prebiotic supplement taken daily split into 2 dosages of 6 g dissolved in water",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Maltodextrin","6 g\u002Fday maltodextrin taken daily split into 2 dosages of 3 g dissolved in water",[15],[31],{"name":32,"affiliation":5,"role":33},"Stephen Lindemann, PhD","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","765-494-9207","lindems@purdue.edu",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Peter Jackson, PhD","7654099789","ppjackso@purdue.edu",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","West Lafayette","Indiana","47907","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-86.90807,40.42587,{"lat":55,"lon":54},[58,59,61,63,65],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},{"name":40,"role":36,"phone":60,"phoneExt":25,"email":42},"765-509-9789",{"name":62,"role":33,"phone":25,"phoneExt":25,"email":25},"Stepehen Lindemann, PhD",{"name":40,"role":64,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"name":66,"role":64,"phone":25,"phoneExt":25,"email":25},"Richard Mattes, Prof",{"type":33,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Stephen R Lindemann, PhD","Associate Professor","100556664","impact-of-native-chicory-inulin-on-change-and-persistence-of-gut-microbiota-100556664",false,"NCT06528041","Impact of Native Chicory Inulin on Change and Persistence of Gut Microbiota","Effect of Native Chicory Inulin Supplementation on Rates of Microbial Change Between Individuals","INFLUX","Inclusion Criteria:\n\n* adults aged 18-45\n* BMI \\>18.5 - \\\u003C 30 kg\u002Fm2\n* Regular bowel movements (\\> 4 days per week)\n\nExclusion Criteria:\n\n* Self-reported sensitivity to FODMAPs and following a low FODMAP diet ((FODMAPS stands for fermentable oligosaccharides, disaccharides, monosaccharides and polyols).\n* Self-reported food allergies and sensitivities including gluten, dairy, nuts, soya and lactose etc.\n* Self-reported antibiotic treatment in the past 6 months.\n* Self-reported history of gastrointestinal disease and\u002For heart disease, cardiovascular, liver, and respiratory disorders, cancer and\u002For clinically relevant (pre) diabetes.\n* Self-reported to having undergone major surgery of the gastrointestinal tract, with the exception of cholecystectomy and appendectomy.\n* Self-reported smoking and\u002For self-reported drug or alcohol abuse.\n* Self-reported history of psychiatric and\u002For mood disorders including eating disorders.\n* Self-reported to be following a restrictive diet (i.e. ketogenic, intermittent fasting).\n* Pregnant and lactating women.",true,"ALL","18 Years","45 Years",{"count":83,"type":84},52,"ESTIMATED","INTERVENTIONAL",[87],"NA","The main aim of this study is to investigate differences in rate, extent of change and persistence of the gut microbiota in healthy adult volunteers in response to native chicory inulin. Along with investigating the impact of native chicory on bowl habits, mood and appetite. The two main questions this study aims to answer:\n\n* To what extent do differences exist in rate of change over time between individuals in gut microbiota response (Bifidobacterium growth) to native chicory inulin supplementation.\n* To what extent do differences exist between individuals in persistence of the gut microbiota upon stopping supplementation.\n\nThe effects of native chicory inulin on gut microbiota response will be compared to a maltodextrin placebo to sure changes in gut microbiota result directly from chicory inulin supplementation.\n\nParticipants will firstly complete a one-week run-in phase to establish baseline data and will then be allocated to either native chicory inulin or maltodextrin supplementation for 6 weeks. Inulin will be delivered at 12 g\u002Fday split into 2 x 6g portions. Maltodextrin will be calorie matched at 6 g\u002Fday split into 2 x 3g portions. This will then be followed by a 6 week post-supplementation phase. Fecal and blood samples will be collected regularly throughout all phases for analysis of gut microbiota and compounds of interest. Participants will also record any changes in gastrointestinal sensation, bowel habits and mood in a diary. Changes in appetite sensation will also measured.",[90],"Healthy",[92,93,94,95],"Gut microbiota","inulin","prebiotics","Bifidobacterium","2025-12-04",{"date":98,"type":99},"2025-12-11","ACTUAL",{"date":101,"type":99},"2024-08-01",{"date":103,"type":84},"2026-07-30",{"name":5,"class":6},1]