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

Not Applicable

Recruiting

• Conditions: Type2diabetes; Heart Failure With Preserved Ejection Fraction
• Interventions: Dietary Supplement: Potato Starch

• Registration Number: NCT06337812
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-03-22
• Study First Posted: 2024-03-29
• Study Start: 2024-04-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Potato starch supplement	Potato Starch	Participants will take the supplement for approximately 4 weeks.

Primary Outcome Measures

Name	Time	Method
Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma	Baseline, approximately 4 weeks	Plasma samples will be analyzed.
Changes in acetate levels- stool	Baseline, approximately 4 weeks	Stool will be analyzed.
Changes in acetate levels- plasma	Baseline, approximately 4 weeks	Plasma samples will be analyzed.
Changes in propionate levels- plasma	Baseline, approximately 4 weeks	Plasma samples will be analyzed.
Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool	Baseline, approximately 4 weeks	Stool will be analyzed.
Changes in propionate levels - stool	Baseline, approximately 4 weeks	Stool will be analyzed.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States