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.
Conditions:
🦠 Type2diabetes 🦠 Heart Failure With Preserved Ejection Fraction
🗓️ Study Start (Actual) 1 April 2024
🗓️ Primary Completion (Estimated) June 2025
✅ Study Completion (Estimated) June 2025
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Ann Arbor, Michigan, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 22 March 2024
  • First Submitted that Met QC Criteria 22 March 2024
  • First Posted 29 March 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 May 2024
  • Last Update Posted 8 May 2024
  • Last Verified May 2024