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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * A confirmed clinical diagnosis of stable HFpEF on maximally tolerated Heart Failure (HF) medical regimen (without changes in dosage in the prior month) * Left ventricular ejection fraction of \>50% documented in the prior 12 months * A confirmed clinical diagnosis of Type II diabetes (T2DM) with glycated hemoglobin \<10% without changes in medical regimen in the past month. Exclusion Criteria: * Current usage of pre- or probiotic usage * Antibiotic usage in the past 6 months * Current participation in another interventional clinical trial * 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 * Hypoglycemic episode with blood glucose 70 milligrams per deciliter (mg/dL) within the last month * Stage IV-V chronic kidney disease * Pregnancy (self-reported) * Comorbidity limiting survival to \< 12 months
About the study
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.
What is being tested
- Potato Starch (dietary supplement)
Sponsor: University of Michigan · Participants: 30 · Started: Apr 1, 2024
Contact the study team
- Hayley Billingsley, PhD · Phone: 734-726-0308
Official record on ClinicalTrials.gov — NCT06337812
Locations in the U.S.
| Michigan | University of Michigan, Ann Arbor |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.