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

Last updated: July 22, 2025
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Heart Failure

Congestive Heart Failure

Treatment

Potato Starch

Clinical Study ID

NCT06337812
HUM00240473
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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

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) withinthe last month

  • Stage IV-V chronic kidney disease

  • Pregnancy (self-reported)

  • Comorbidity limiting survival to < 12 months

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Potato Starch
Phase:
Study Start date:
April 01, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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