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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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 (1)

University of Michigan
Ann Arbor, Michigan, United States