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

University of Michigan

Status

Enrolling

Conditions

Type2diabetes

Heart Failure With Preserved Ejection Fraction

Treatments

Dietary Supplement: Potato Starch

Study type

Interventional

Funder types

Other

Identifiers

NCT06337812

HUM00240473

Details and patient eligibility

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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