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NCT Number: NCT06337812

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

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.

Recruiting

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Key information

Conditions

Type2diabetes Heart Failure With Preserved Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Hayley Billingsley, PhD

CONTACT

[email protected]

734-726-0308

Scott Hummel, MD, MS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Potato Starch

Dietary Supplement

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.

Primary outcomes

  1. Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool

    Time frame: Baseline, approximately 4 weeks

    Stool will be analyzed.

  2. Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma

    Time frame: Baseline, approximately 4 weeks

    Plasma samples will be analyzed.

  3. Changes in propionate levels - stool

    Time frame: Baseline, approximately 4 weeks

    Stool will be analyzed.

  4. Changes in propionate levels- plasma

    Time frame: Baseline, approximately 4 weeks

    Plasma samples will be analyzed.

  5. Changes in acetate levels- stool

    Time frame: Baseline, approximately 4 weeks

    Stool will be analyzed.

  6. Changes in acetate levels- plasma

    Time frame: Baseline, approximately 4 weeks

    Plasma samples will be analyzed.

Study contacts

Contact information is provided by the study sponsor or research team.

Hayley Billingsley, PhD

CONTACT

[email protected]

734-726-0308

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 29, 2024
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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