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

July 22, 2025 updated by: Scott L. Hummel, University of Michigan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Scott Hummel, MD, MS

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Potato starch supplement
Participants will take the supplement for approximately 4 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool
Time Frame: Baseline, approximately 4 weeks
Stool will be analyzed.
Baseline, approximately 4 weeks
Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma
Time Frame: Baseline, approximately 4 weeks
Plasma samples will be analyzed.
Baseline, approximately 4 weeks
Changes in propionate levels - stool
Time Frame: Baseline, approximately 4 weeks
Stool will be analyzed.
Baseline, approximately 4 weeks
Changes in propionate levels- plasma
Time Frame: Baseline, approximately 4 weeks
Plasma samples will be analyzed.
Baseline, approximately 4 weeks
Changes in acetate levels- stool
Time Frame: Baseline, approximately 4 weeks
Stool will be analyzed.
Baseline, approximately 4 weeks
Changes in acetate levels- plasma
Time Frame: Baseline, approximately 4 weeks
Plasma samples will be analyzed.
Baseline, approximately 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Scott Hummel, MD, MS, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2025

Last Update Submitted That Met QC Criteria

July 22, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00240473

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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