Actively Recruiting
Fiber Supplementation to Increase Short Chain Fatty Acid Production in Patients With Type II Diabetes and Heart Failure With Preserved Ejection Fraction
Led by University of Michigan · Updated on 2025-07-24
30
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how increasing dietary fiber by adding potato starch to the diet may affect the types of bacteria in the gut microbiome of people with stable Heart Failure With Preserved Ejection Fraction (HFpEF) and Type II diabetes. They also want to see if this supplement helps these bacteria produce more short chain fatty acids, which might benefit health. Participants will take a potato starch supplement for about 4 weeks. They will start by consuming 10 grams twice a day for the first week, then increase to 20 grams daily for approximately 3 weeks. The potato starch can be mixed into cold food or drinks. During the study, participants will have evaluations and provide blood and stool samples. Throughout the study, researchers will measure changes in short chain fatty acid levels, including butyrate, propionate, and acetate, in stool and plasma samples at the start and after about 4 weeks. The study is sponsored by the University of Michigan and no masking or blinding is used. Participants will be monitored for health and safety during the treatment period.
CONDITIONS
Brief Title
Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A confirmed clinical diagnosis of stable HFpEF on maximally tolerated Heart Failure medical regimen without dosage changes in the prior month
- Left ventricular ejection fraction greater than 50% documented within the last 12 months
- A confirmed clinical diagnosis of Type II diabetes with glycated hemoglobin less than 10% and stable medical regimen for the past month
You will not qualify if you...
- Current use of prebiotics or probiotics
- Antibiotic use within the past 6 months
- Participation in another interventional clinical trial
- History of allergy to potato or potato starch
- History of 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 below 70 mg/dL within the last month
- Stage IV or V chronic kidney disease
- Pregnancy (self-reported)
- Comorbid conditions limiting survival to less than 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 weeks
Participants consume potato starch supplement daily and provide blood and stool samples for evaluation.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
H
Hayley Billingsley, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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