Increasing dietary fiber in patients with heart failure and diabetes
Official title: 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
Run by University of Michigan · NCT06337812 · Data updated 2026-11-12
This study tests if adding potato starch to the diets of people with heart failure and diabetes can improve their gut health and overall well-being.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Status | Recruiting |
| Started | April 1, 2024 |
| Main results expected | June 2026 |
| Study ends | December 2026 |
| Registry record updated | July 24, 2025 |
| Trial ID | NCT06337812 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with stable HFpEF and type 2 diabetes who are on a maximally tolerated heart failure medication regimen.
✕Probably not a fit
Patients with a history of certain gastrointestinal disorders or those currently using pre- or probiotics may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of dietary fiber supplementation, specifically potato starch, on the gut microbiome of patients with heart failure with preserved ejection fraction (HFpEF) and type 2 diabetes. Participants will incorporate potato starch into their diet to assess changes in gut bacteria and the production of beneficial short-chain fatty acids. The study aims to determine whether these dietary changes can improve health outcomes for individuals with these conditions.
Why it matters
Potential benefit: If successful, this approach could enhance gut health and potentially improve heart failure symptoms in patients with preserved ejection fraction.
How similar studies have gone: While the specific approach of using potato starch is novel, studies on dietary fiber's impact on gut health in similar populations have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Michigan
Ann Arbor, Michigan, United States Recruiting
Study contacts
- Principal investigator: Scott Hummel, MD, MS — University of Michigan
- Study coordinator: Hayley Billingsley, PhD
- Email: hbilings@med.umich.edu
- Phone: 734-726-0308
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Remote rehabilitation for HFpEF patients using telerehabilitation
A home-based telerehabilitation program is being tested to see if it is safe and helpful for people with heart failure with preserved ejection fraction.
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EDG-15400 in adults with HFpEF: a phase 2 study
This phase 2 study tests different doses of EDG-15400 against placebo in adults with HFpEF to see if it is safe and tolerable.
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Incretin therapy with tirzepatide for obesity-related HFpEF
A 15-month study will test whether tirzepatide helps people with obesity and HFpEF by reducing plasma volume.
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Technology-assisted home strength training for adults 55–80 with type 2 diabetes and mild cognitive impairment
This 12-week program will test whether a telehealth-supported home strength-training routine helps adults 55–80 with type 2 diabetes and mild cognitive impairment stick with exercise and improve strength, thinking, and blood sugar.
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Boosted exercise with group coaching for HFpEF
This trial tests a blended, guided exercise program with group coaching and remote monitoring to see if it helps older adults with HFpEF improve activity and health at a lower cost.
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Exercise cardiac MRI for heart failure with preserved ejection fraction
This study will try low-field exercise cardiac MRI to see if it can diagnose, describe, and predict risk in people with HFpEF compared with those who have non-cardiac breathlessness and healthy volunteers.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.