[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542049":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":48,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":20,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"University of Michigan","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Potato starch supplement","EXPERIMENTAL","Participants will take the supplement for approximately 4 weeks.",[13],"Dietary Supplement: Potato Starch",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIETARY_SUPPLEMENT","Potato Starch","Participants will consume 10 grams (1\u002F2 a packet) of Bob's Red Mill Potato Starch twice a day for the first 7 days and then increase to 20 grams (full packet) of potato starch for approximately 3 weeks. Potato starch can be mixed into cold food or beverage for consumption.\n\nIn addition, participants will have evaluations and provide blood and stool samples during the study.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Scott Hummel, MD, MS","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Hayley Billingsley, PhD","CONTACT","734-726-0308","hbilings@med.umich.edu",[32],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-83.74088,42.27756,{"lat":43,"lon":42},[46,47],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":24,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Scott L. Hummel","Associate Professor","100542049","fiber-supplementation-in-heart-failure-with-preserved-ejection-fraction-hfpef-100542049",false,"NCT06337812","Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF)","Fiber Supplementation to Increase Short Chain Fatty Acid Production in Patients With Type II Diabetes and Heart Failure With Preserved Ejection Fraction - the FERMENT HFpEF Trial","Inclusion Criteria:\n\n* A confirmed clinical diagnosis of stable HFpEF on maximally tolerated Heart Failure (HF) medical regimen (without changes in dosage in the prior month)\n* Left ventricular ejection fraction of \\>50% documented in the prior 12 months\n* A confirmed clinical diagnosis of Type II diabetes (T2DM) with glycated hemoglobin \\\u003C10% without changes in medical regimen in the past month.\n\nExclusion Criteria:\n\n* Current usage of pre- or probiotic usage\n* Antibiotic usage in the past 6 months\n* Current participation in another interventional clinical trial\n* History of potato allergy or potato starch allergy, inflammatory bowel syndrome, inflammatory bowel disease, bowel resection, Roux-en-Y gastric bypass surgery, celiac disease, Crohn's disease, or colorectal cancer\n* Hypoglycemic episode with blood glucose 70 milligrams per deciliter (mg\u002FdL) within the last month\n* Stage IV-V chronic kidney disease\n* Pregnancy (self-reported)\n* Comorbidity limiting survival to \\\u003C 12 months","ALL","18 Years",{"count":61,"type":62},30,"ESTIMATED","INTERVENTIONAL",[65],"NA","The study team is studying how increasing dietary fiber, specifically through adding potato starch to participant's diet, may impact the species of bacteria in participant's gut microbiome. The study team also wants to understand if adding potato starch to participant's diet helps these bacteria make more short chain fatty acids, a byproduct the team thinks may benefit participant's health.",[68,69],"Type2diabetes","Heart Failure With Preserved Ejection Fraction",[71,17,72,73],"Fiber Supplementation","Gut microbiome","Resistant starch","2025-07-22",{"date":76,"type":77},"2025-07-24","ACTUAL",{"date":79,"type":77},"2024-04-01",{"date":81,"type":62},"2026-12",{"name":5,"class":6},1]