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

Launched by UNIVERSITY OF MICHIGAN · Mar 22, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of adding a fiber supplement, specifically potato starch, to the diets of people with heart failure and type 2 diabetes. The researchers want to see if increasing fiber can change the types of bacteria in the gut and help these bacteria produce more beneficial compounds called short-chain fatty acids, which could improve health outcomes for participants.

To join the study, participants need to be between the ages of 65 and 74 and have a stable diagnosis of heart failure with preserved ejection fraction, meaning their heart is functioning well enough. They should also have type 2 diabetes that is well-managed. Participants who are currently taking probiotics, have certain health conditions, or have had recent antibiotic use may not be eligible. Those who join can expect to follow the study's dietary changes and help researchers learn more about the connection between diet, gut health, and heart health.

Gender

ALL

Eligibility criteria

• 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