Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Potato Starch.
- Who it may be relevant to
- Registry conditions: Type2diabetes, Heart Failure With Preserved Ejection Fraction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool [Time frame: Baseline, approximately 4 weeks]
- Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma [Time frame: Baseline, approximately 4 weeks]
- Changes in propionate levels - stool [Time frame: Baseline, approximately 4 weeks]
- Changes in propionate levels- plasma [Time frame: Baseline, approximately 4 weeks]
- Changes in acetate levels- stool [Time frame: Baseline, approximately 4 weeks]
- Changes in acetate levels- plasma [Time frame: Baseline, approximately 4 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT06337812 · HUM00240473