Fiber Supplementation for Heart Failure and Type 2 Diabetes

This study is looking at how adding a fiber supplement, Bob's Red Mill Potato Starch, to your diet might affect your gut health if you have heart failure with preserved ejection fraction (HFpEF) and Type 2 diabetes. Researchers want to see if this potato starch helps the bacteria in your gut make more short chain fatty acids, which they believe could be beneficial. You may be able to join if you are an adult with stable HFpEF (meaning your heart's pumping ability is over 50%) and Type 2 diabetes with well-controlled blood sugar (glycated hemoglobin under 10%). The study aims to enroll 30 participants and will measure changes in specific short chain fatty acids in your stool and blood after about 4 weeks.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved
You will consume Bob's Red Mill Potato Starch twice a day, starting with 10 grams for 7 days, then increasing to 20 grams for approximately 3 weeks. Stool and plasma samples will be collected at the beginning and after about 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 4 weeks to measure changes in short chain fatty acid levels.

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NCT06337812

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

Recruiting
NAAges 18+InterventionalHealth services
University of Michigan
~30 participants
Updated 2025-07-24 on ClinicalTrials.gov
What's tested:Potato Starch

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool
Measured over Baseline, approximately 4 weeks
+5 more outcomes measured
Type2diabetes
Heart Failure With Preserved Ejection Fraction
1 sites across 1 states
Michigan1
  • Scott Hummel, MD, MS · PRINCIPAL_INVESTIGATOR · University of Michigan

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Eligibility criteria

Inclusion

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

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
  • Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stoolBaseline, approximately 4 weeks

    Stool will be analyzed.

  • Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasmaBaseline, approximately 4 weeks

    Plasma samples will be analyzed.

  • Changes in propionate levels - stoolBaseline, approximately 4 weeks

    Stool will be analyzed.

  • Changes in propionate levels- plasmaBaseline, approximately 4 weeks

    Plasma samples will be analyzed.

  • Changes in acetate levels- stoolBaseline, approximately 4 weeks

    Stool will be analyzed.

  • Changes in acetate levels- plasmaBaseline, approximately 4 weeks

    Plasma samples will be analyzed.