[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657518":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":17,"armGroups":28,"interventions":41,"overallOfficials":50,"centralContacts":54,"locations":64,"responsibleParty":78,"collaborators":81,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":17,"eligibilityCriteria":89,"healthyVolunteers":86,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":17,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":108,"whyStopped":17,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Purdue University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Colonic butyrogenic Clostridium clusters IV and XIVa","Changes in composition of bacterial taxa belonging to Clostridium clusters IV and XIVa will be assessed following consumption of the whole-food fiber mixture compared with inulin using 16S rRNA gene sequencing of fecal samples.","Outcomes will be analyzed at the beginning (week 0 and week 8) and end of each supplementation period (week 4 and week 12).",[14],{"measure":15,"description":16,"timeFrame":12},"Blood markers of gut and systemic health effects","Mesures in blood of gut metabolites: short-chain fatty acid (SCFAs) concentrations (mM).\n\nMeasures of intestinal barrier integrity: zonulin (ng\u002FmL), intestinal fatty acid-binding protein (ng\u002FmL).\n\nMeasures of bacterial translocation in the gut: lipopolysaccharide \\[LPS\\] (ng\u002FmL), LPS-binding protein (ng\u002FmL).\n\nMeasures of systemic inflammatory cytokines: IL-1, IL-6, IL-8, TNF-alpha and IL-10 (pg\u002FmL).\n\nMeasure of metabolic health: HOMA-IR.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","CROSSOVER","BASIC_SCIENCE",{"masking":23,"maskingDescription":17,"whoMasked":24},"TRIPLE",[25,26,27],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"Whole food fiber mixture","EXPERIMENTAL","For a duration of 4 weeks, participants will consume 2 servings per day of a whole-food fiber powder mixture designed by the research team. This intervention period will be followed by a 4-week washout period during which participants will not consume any dietary supplements.",[34],"Dietary Supplement: Whole food fiber mixture",{"label":36,"type":37,"description":38,"interventionNames":39},"Inulin","ACTIVE_COMPARATOR","For a duration of 4 weeks, participants will consume 2 servings per day of a commercially available Inulin. This intervention period will be followed by a 4-week washout period during which participants will not consume any dietary supplements.",[40],"Dietary Supplement: inulin",[42,46],{"type":43,"name":30,"description":44,"armGroupLabels":45,"otherNames":17},"DIETARY_SUPPLEMENT","Participants will consume 2 servings per day of a whole-food fiber-based mixture packaged in the form of a sachet, prepared by an external manufacturer , and diluted in 100 mL of water prior to consumption. Each serving contains 7.5 g of a whole-food fiber mixture (designed by the research team), 0.7 g of flavor (berry, banana, or lemon), 0.2 g of guar gum (thickening agent), 0.5 g citric acid, and 0.1 g stevia.",[30],{"type":43,"name":47,"description":48,"armGroupLabels":49,"otherNames":17},"inulin","Participants will consume 2 servings per day of an inulin packaged in the form of a sachet, prepared by an external manufacturer, and diluted in 100 mL of water prior to consumption. Each serving contains 7.5 g of commercially sourced isolated inulin, 0.7 g of flavor (berry, banana or lemon), 0.2 g of guar gum (thickening agent), 0.5 g citric acid, and 0.1g stevia.",[36],[51],{"name":52,"affiliation":5,"role":53},"Thaisa M Cantu-Jungles, PhD","PRINCIPAL_INVESTIGATOR",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":17,"email":59},"Thaisa Cantu Jungles","CONTACT","765-494-7997","tcantuju@purdue.edu",{"name":61,"role":57,"phone":62,"phoneExt":17,"email":63},"Bruce Hamaker, PhD","765-418-1995","hamakerb@purdue.edu",[65],{"facility":66,"status":17,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":17},"Clinical Research Center at Purdue University","West Lafayette","Indiana","47907","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-86.90807,40.42587,{"lat":76,"lon":75},{"type":53,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"CantuJungles","Professor",[82],{"name":83,"class":6},"Rush University Medical Center","100657518","whole-food-fibers-for-support-of-key-gut-bacteria-for-human-health-100657518",false,"NCT07840170","Whole Food Fibers for Support of Key Gut Bacteria for Human Health","Inclusion Criteria:\n\n* Overweight or obese, defined as a Body Mass Index (BMI) of 25 to 35 kg\u002Fm²\n* Prediabetic (HbA1c: 5.7 - 6.3), though otherwise healthy subjects\n* 18-65 years age\n\nExclusion Criteria:\n\n* Kidney dysfunction\n* Thyroid dysfunction\n* Liver dysfunction\n* Use of antibiotics in the last four weeks\n* Use of probiotics in the last four weeks\n* Use of prebiotics in the last four weeks","ALL","18 Years","65 Years",{"count":94,"type":95},24,"ESTIMATED","INTERVENTIONAL",[98],"NA","The purpose of this supplementation study is to understand how whole food fibers may affect gut microbiota composition and overall health. The investigators will enroll up to 24 people in this study. To be eligible, participants need to be between 18 and 65 years old, have a Body Mass Index of 25 to 35 kg\u002Fm², be prediabetic (HbA1c: 5.7 - 6.3), be free of any inflammatory bowel disease or any colon-related disease, be free of wheat allergens or intolerance, and not be pregnant or nursing. If participants have any questions about the criteria, they will ask the investigator consenting them. This is a randomized, cross-over, double-blind, clinical trial (RCT) that will last 12 consecutive weeks in total (4 weeks of treatment A + 4 weeks of washout + 4 weeks of treatment B). The order of the treatments will be randomly assigned before the beginning of the study. If proved right, this study will provide a science-based fiber reason why consumption of whole foods constitutes a better dietary approach than the current practice of adding soluble dietary fiber (inulin) alone to modulate gut microbiota for gut and whole-body health.",[101],"Prediabetes or Overweight",[103,104,105,106,107],"whole foods","dietary fiber","prebiotics","gut microbiota","gut health","NOT_YET_RECRUITING","2026-09-21",{"date":111,"type":112},"2026-09-24","ACTUAL",{"date":114,"type":95},"2026-11-01",{"date":116,"type":95},"2027-04-30",{"name":5,"class":6},1]