Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF)

NCT ID: NCT06337812

Last Updated: 2025-07-24

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type2diabetes Heart Failure With Preserved Ejection Fraction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Potato starch supplement

Participants will take the supplement for approximately 4 weeks.

Group Type EXPERIMENTAL

Potato Starch

Intervention Type DIETARY_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.

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Scott L. Hummel

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hayley Billingsley, PhD

Role: CONTACT

734-726-0308

Facility Contacts

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Hayley Billingsley, PhD

Role: primary

734-726-0308

Other Identifiers

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HUM00240473

Identifier Type: -

Identifier Source: org_study_id

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