RecruitingNot ApplicableNCT06337812

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

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

Sponsor

University of Michigan

Enrollment

30 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Type2diabetes Heart Failure With Preserved Ejection Fraction

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a fiber supplement (potato starch) can improve heart function and blood sugar control in people who have heart failure with preserved ejection fraction (HFpEF — a type of heart failure where the heart pumps normally but is too stiff) and type 2 diabetes. **You may be eligible if...** - You have stable HFpEF (your heart's pumping function is above 50%) and are on a stable medication regimen - You have type 2 diabetes with an HbA1c (average blood sugar) below 10%, on a stable medication regimen **You may NOT be eligible if...** - You currently take prebiotics or probiotics - You used antibiotics in the past 6 months - You are already in another clinical trial - You have a potato or potato starch allergy, inflammatory bowel disease, celiac disease, Crohn's disease, prior bowel surgery, or colorectal cancer - You had a low blood sugar episode (under 70 mg/dL) in the past month - You have stage IV or V chronic kidney disease - You are pregnant - You have a condition that limits your life expectancy to less than 12 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTPotato 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.