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

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

Fiber Supplementation to Increase Short Chain Fatty Acid Production in Patients With Type II Diabetes and Heart Failure With Preserved Ejection Fraction - the FERMENT HFpEF Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06337812
• Other study ID #: HUM00240473
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: Hayley Billingsley, PhD
• Phone: 734-726-0308
• Email: hbilings[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool	Stool will be analyzed.	Baseline, approximately 4 weeks
Primary	Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma	Plasma samples will be analyzed.	Baseline, approximately 4 weeks
Primary	Changes in propionate levels - stool	Stool will be analyzed.	Baseline, approximately 4 weeks
Primary	Changes in propionate levels- plasma	Plasma samples will be analyzed.	Baseline, approximately 4 weeks
Primary	Changes in acetate levels- stool	Stool will be analyzed.	Baseline, approximately 4 weeks
Primary	Changes in acetate levels- plasma	Plasma samples will be analyzed.	Baseline, approximately 4 weeks