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

Description

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.

Conditions

Type2diabetes, Heart Failure With Preserved Ejection Fraction

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Type2diabetes
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

Scott Hummel, MD, MS, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2025-06