Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF)
NCT ID: NCT06337812
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-04-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Potato starch supplement
Participants will take the supplement for approximately 4 weeks.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Scott L. Hummel
Associate Professor
Principal Investigators
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Scott Hummel, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00240473
Identifier Type: -
Identifier Source: org_study_id
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