Increasing dietary fiber in patients with heart failure and diabetes
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
NA · University of Michigan · NCT06337812
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan (other) |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06337812 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with stable HFpEF and type 2 diabetes who are on a maximally tolerated heart failure medication regimen.
Not a fit: Patients with a history of certain gastrointestinal disorders or those currently using pre- or probiotics may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type2diabetes, Heart Failure With Preserved Ejection Fraction, Fiber Supplementation, Potato Starch, Gut microbiome, Resistant starch