RecruitingNot ApplicableNCT06337812

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

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

Sponsor

University of Michigan

Enrollment

30 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Type2diabetes Heart Failure With Preserved Ejection Fraction

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria8

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

Interventions

DIETARY_SUPPLEMENTPotato 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.