Recruiting

Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF)

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.

ClinicalTrials.gov IDNCT06337812

PhaseNA

Enrollment30

SponsorUniversity of Michigan

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Type2diabetes, Heart Failure With Preserved Ejection Fraction

About this study

Interventions

Dietary Supplement: Potato Starch — Participants will consume 10 grams (1/2 a packet) of Bob's Red Mill Potato Starch twice a day for the first 7 days and then increase to 20 grams (full packet) of potato starch for approximately 3 weeks. Potato starch can be mixed into cold food or beverage for consumption. In addition, participants will have evaluations and provide blood and stool samples during the study.

Primary outcomes

Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool (Baseline, approximately 4 weeks)
Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma (Baseline, approximately 4 weeks)
Changes in propionate levels - stool (Baseline, approximately 4 weeks)
Changes in propionate levels- plasma (Baseline, approximately 4 weeks)
Changes in acetate levels- stool (Baseline, approximately 4 weeks)
Changes in acetate levels- plasma (Baseline, approximately 4 weeks)

Eligibility information

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

Study locations

University of Michigan, Ann Arbor, Michigan 48109 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.