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

NCT06337812 | Recruiting

• 1 other identifier: HUM00240473
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Fiber Supplementation; Potato Starch; Gut microbiome; Resistant starch

Outcome Measures

Primary Outcomes (6)

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

  Stool will be analyzed.

  Baseline, approximately 4 weeks

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

  Plasma samples will be analyzed.

  Baseline, approximately 4 weeks

• Changes in propionate levels - stool

  Stool will be analyzed.

  Baseline, approximately 4 weeks

• Changes in propionate levels- plasma

  Plasma samples will be analyzed.

  Baseline, approximately 4 weeks

• Changes in acetate levels- stool

  Stool will be analyzed.

  Baseline, approximately 4 weeks

• Changes in acetate levels- plasma

  Plasma samples will be analyzed.

  Baseline, approximately 4 weeks

Study Arms (1)

Potato starch supplement

EXPERIMENTAL

Participants will take the supplement for approximately 4 weeks.

Dietary Supplement: Potato Starch

Interventions

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.

Potato starch supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Study Officials

• Scott Hummel, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hayley Billingsley, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)