Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF)
Recruiting · NCT06337812 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Michigan
View the official record on ClinicalTrials.gov →Interventions studied
Potato Starch
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed across 1 US state.
- University of Michigan - Ann Arbor, Michigan, United States
- University of Michigan - Ann Arbor, Michigan, United States