RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-04-01
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06337812

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * A confirmed clinical diagnosis of stable HFpEF on maximally tolerated Heart Failure (HF) medical regimen (without changes in dosage in the prior month)
  2. * Left ventricular ejection fraction of \>50% documented in the prior 12 months
  3. * A confirmed clinical diagnosis of Type II diabetes (T2DM) with glycated hemoglobin \<10% without changes in medical regimen in the past month.
  1. * Current usage of pre- or probiotic usage
  2. * Antibiotic usage in the past 6 months
  3. * Current participation in another interventional clinical trial
  4. * 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
  5. * Hypoglycemic episode with blood glucose 70 milligrams per deciliter (mg/dL) within the last month
  6. * Stage IV-V chronic kidney disease
  7. * Pregnancy (self-reported)
  8. * Comorbidity limiting survival to \< 12 months

Contacts and Locations

Study Contact

Hayley Billingsley, PhD
CONTACT
734-726-0308
hbilings@med.umich.edu

Principal Investigator

Scott Hummel, MD, MS
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Scott Hummel, MD, MS, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01
Study Completion Date2025-06

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • Fiber Supplementation
  • Potato Starch
  • Gut microbiome
  • Resistant starch

Additional Relevant MeSH Terms

  • Type2diabetes
  • Heart Failure With Preserved Ejection Fraction