Type2diabetesNCT06337812
Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF)
A study testing Potato Starch in people with Type2diabetes and Heart Failure With Preserved Ejection Fraction, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2diabetes, Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Potato Starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Hayley Billingsley, PhD, 734-726-0308, hbilings@med.umich.edu
Scott Hummel, MD, MS
About this study
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
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.
- Being tested
- Potato Starch
- Keywords
- Fiber Supplementation, Potato Starch, Gut microbiome, Resistant starch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potato StarchDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Potato starch supplement | Experimental | Participants will take the supplement for approximately 4 weeks. Receives: Dietary Supplement: Potato Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool
Stool will be analyzed.
Measured: Baseline, approximately 4 weeks
Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma
Plasma samples will be analyzed.
Measured: Baseline, approximately 4 weeks
Changes in propionate levels - stool
Stool will be analyzed.
Measured: Baseline, approximately 4 weeks
Changes in propionate levels- plasma
Plasma samples will be analyzed.
Measured: Baseline, approximately 4 weeks
Changes in acetate levels- stool
Stool will be analyzed.
Measured: Baseline, approximately 4 weeks
Changes in acetate levels- plasma
Plasma samples will be analyzed.
Measured: Baseline, approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Apr 2024
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott L. Hummel, University of Michigan
- Investigators
- Scott Hummel, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337812
- Sponsor's protocol ID
- HUM00240473
- Status last verified
- Jul 2025
- First submitted
- 22 Mar 2024
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06337812
- Acronym / sponsor ID
- HUM00240473
- Keywords
- Fiber Supplementation, Potato Starch, Gut microbiome, Resistant starch
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Potato starch supplement | Experimental | Dietary Supplement: Potato StarchParticipants will take the supplement for approximately 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potato StarchParticipants 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. | Dietary supplement | Potato starch supplement |
Primary outcome
Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool
Time frame: Baseline, approximately 4 weeks
Stool will be analyzed.
Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma
Time frame: Baseline, approximately 4 weeks
Plasma samples will be analyzed.
Changes in propionate levels - stool
Time frame: Baseline, approximately 4 weeks
Stool will be analyzed.
Changes in propionate levels- plasma
Time frame: Baseline, approximately 4 weeks
Plasma samples will be analyzed.
Changes in acetate levels- stool
Time frame: Baseline, approximately 4 weeks
Stool will be analyzed.
Changes in acetate levels- plasma
Time frame: Baseline, approximately 4 weeks
Plasma samples will be analyzed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott Hummel, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potato Starch in people with Type2diabetes and Heart Failure With Preserved Ejection Fraction, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hayley Billingsley, PhD (734-726-0308, hbilings@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool (time frame: Baseline, approximately 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.