Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Potato Starch
Dietary supplementParticipants 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Potato starch supplementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool
Stool will be analyzed.
Time frame
Baseline, approximately 4 weeks2
Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma
Plasma samples will be analyzed.
Time frame
Baseline, approximately 4 weeks3
Changes in propionate levels - stool
Stool will be analyzed.
Time frame
Baseline, approximately 4 weeks4
Changes in propionate levels- plasma
Plasma samples will be analyzed.
Time frame
Baseline, approximately 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov