Recruiting

Fiber Supplementation

Sponsor:

University of Michigan

Code:

NCT06337812

Conditions

Type2diabetes

Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Potato Starch

Study Details

Brief 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.

Conditions

Type2diabetes

Heart Failure With Preserved Ejection Fraction

Study ID

NCT06337812

Start date

Apr 1, 2024

Status verified date

Jul, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Potato starch supplement

Participants will take the supplement for approximately 4 weeks.

Interventions

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.

Primary outcome measure

  • Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool [ Time Frame: Baseline, approximately 4 weeks ]
  • Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma [ Time Frame: Baseline, approximately 4 weeks ]
  • Changes in propionate levels - stool [ Time Frame: Baseline, approximately 4 weeks ]
  • Changes in propionate levels- plasma [ Time Frame: Baseline, approximately 4 weeks ]
  • Changes in acetate levels- stool [ Time Frame: Baseline, approximately 4 weeks ]
  • Changes in acetate levels- plasma [ Time Frame: Baseline, approximately 4 weeks ]

Central Contacts and Locations

Central contacts

Hayley Billingsley, PhD

734-726-0308hbilings@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Hayley Billingsley, PhD

734-726-0308hbilings@med.umich.edu

Principal Investigator:

Scott Hummel, MD, MS

More Information

Sponsor

University of Michigan

Last update posted

Jul 24, 2025

Last verified

Jul, 2025

Keywords

  • Fiber Supplementation
  • Potato Starch
  • Gut microbiome
  • Resistant starch

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-07-24.