RECRUITING

Impact of Supplemental Fiber on Gut and Vascular Health Related in Obesity Phenotypes

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Conditions

Metabolic SyndromeHealthy ParticipantsMetabolically Healthy ObesityMetabolically Abnormal Obesityfibervascular healthgut healthinflammation

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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

Based on prior research, the investigators are interested in whether an intervention targeting gut health (supplemental fiber for 9 weeks total) will improve vascular health in individuals with obesity. Additionally, the investigators are interested in if this response differs based on whether individuals with obesity have very few heart disease risk factors or several heart disease risk factors.

Official Title

Interplay Between Metabolic Risk Factors, Body Mass Index, and the Gut/Vascular Response to Supplemental Fiber

Quick Facts

Study Start:2025-05-20
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07095426

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 to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants are 18-55 years old.
  2. * Participants BMI is ≥30 kg/m2 - this BMI requirement is due to our research aims.
  3. * Participants have either 0-1 or 2+ of the following risk factors outside of the normal reference ranges: blood pressure, blood sugar, triglycerides, and HDL-cholesterol.
  4. * Participants are not pregnant or expecting to become pregnant (females only). •Participants are not postmenopausal (females only).
  5. * Participants have not been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).
  6. * Participants have not been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease, diverticulosis/diverticulitis).
  7. * Participants do not regularly take anti-inflammatory drugs (more than 2x week) and are willing to suspend use of these medications for 3 days leading up to in-lab visits.
  8. * Participants do not take weight-loss medications (e.g., Ozempic, Wegovy).
  9. * Participants do not use tobacco products or any illicit drugs.
  10. * Participants have not used antibiotics or probiotics in the last month.
  11. * Participants do not have dietary restrictions prohibiting them from consuming the fiber supplement (e.g., food allergies/intolerance).
  12. * Participants do not have a pacemaker.
  13. * Participants are able to lie on their back (supine position) in the dark for at least 10 minutes (related to vascular measurements).
  1. * Participants are not 18-55 years old.
  2. * Participants BMI is not ≥30 kg/m2 - this BMI requirement is due to our research aims.
  3. * Participants do not have either 0-1 or 2+ of the following risk factors outside of the normal reference ranges: blood pressure, blood sugar, triglycerides, and HDL-cholesterol.
  4. * Participants are pregnant or expecting to become pregnant (females only).
  5. * Participants are postmenopausal (females only).
  6. * Participants have been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).
  7. * Participants have been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease, diverticulosis/diverticulitis). •Participants regularly take anti-inflammatory drugs (more than 2x week) and are not willing to suspend use of these medications for 3 days leading up to in-lab visits.
  8. * Participants take weight-loss medications (e.g., Ozempic, Wegovy).
  9. * Participants use tobacco products or any illicit drugs.
  10. * Participants have used antibiotics or probiotics in the last month.
  11. * Participants have dietary restrictions prohibiting them from consuming the fiber supplement (e.g., food allergies/intolerance).
  12. * Participants have a pacemaker.

Contacts and Locations

Study Contact

Bryant Keirns, PhD
CONTACT
765-285-8356
bryant.keirns@bsu.edu

Principal Investigator

Bryant Keirns, PhD
PRINCIPAL_INVESTIGATOR
Ball State University

Study Locations (Sites)

Health Professions Building
Muncie, Indiana, 47306
United States

Collaborators and Investigators

Sponsor: Ball State University

  • Bryant Keirns, PhD, PRINCIPAL_INVESTIGATOR, Ball State University

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 Date2025-05-20
Study Completion Date2027-05

Study Record Updates

Study Start Date2025-05-20
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

  • fiber
  • vascular health
  • gut health
  • inflammation

Additional Relevant MeSH Terms

  • Metabolic Syndrome
  • Healthy Participants
  • Metabolically Healthy Obesity
  • Metabolically Abnormal Obesity