NCT06337812Recruiting
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
Source: ClinicalTrials.gov · Last updated 24 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 22 Mar 2024
- Start date
- 1 Apr 2024
- Primary completion date
- Jun 2026
- Lead sponsor
- University of Michigan
- Diseases
- Heart failure, Type 2 diabetes
- NCT number
- NCT06337812
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Apr 2024 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- Hypoglycemic episode with blood glucose 70 milligrams per deciliter (mg/dL) within the last month
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.