Type2diabetes, Heart Failure With Preserved Ejection Fraction
Conditions
Keywords
Fiber Supplementation, Potato Starch, Gut microbiome, Resistant starch
Brief summary
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_SUPPLEMENTPotato 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.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool | Baseline, approximately 4 weeks | Stool will be analyzed. |
| Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma | Baseline, approximately 4 weeks | Plasma samples will be analyzed. |
| Changes in propionate levels - stool | Baseline, approximately 4 weeks | Stool will be analyzed. |
| Changes in propionate levels- plasma | Baseline, approximately 4 weeks | Plasma samples will be analyzed. |
| Changes in acetate levels- stool | Baseline, approximately 4 weeks | Stool will be analyzed. |
| Changes in acetate levels- plasma | Baseline, approximately 4 weeks | Plasma samples will be analyzed. |
Countries
United States
Contacts
Primary ContactHayley Billingsley, PhD
Outcome results
None listed