Tests potato starch fiber in people with diabetes and heart failure
Tests potato starch added to diet in adults with diabetes and heart failure.
Plain-language title generated from the registry record
Registry title: Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF)
Key facts
- Where
- Ann Arbor, United StatesSee the site
Where in United States
- University of MichiganAnn Arbor, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Michigan
- Trial code
- NCT06337812
- Record updated
- 24 July 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; Stage IV-V chronic kidney disease; Hypoglycemic episode with blood glucose 70 milligrams per deciliter (mg/dL) within the last month; Current usage of pre- or probiotic usage; Antibiotic usage in the past 6 months; Current participation in another interventional clinical trial; Pregnancy (self-reported); Comorbidity limiting survival to < 12 months.