Recruiting

Supplemental Fiber

Sponsor:

Ball State University

Code:

NCT07095426

Conditions

Metabolic Syndrome

Healthy Participants

Metabolically Healthy Obesity

Metabolically Abnormal Obesity

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

inulin

Study Details

Brief summary:

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.

Conditions

Metabolic Syndrome

Healthy Participants

Metabolically Healthy Obesity

Metabolically Abnormal Obesity

Study ID

NCT07095426

Start date

May 20, 2025

Status verified date

Jul, 2025

Completion date

May, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Participants are 18-55 years old.
  • Participants BMI is ≥30 kg/m2 - this BMI requirement is due to our research aims.
  • 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.
  • Participants are not pregnant or expecting to become pregnant (females only). •Participants are not postmenopausal (females only).
  • Participants have not been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).
  • Participants have not been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease, diverticulosis/diverticulitis).
  • 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.
  • Participants do not take weight-loss medications (e.g., Ozempic, Wegovy).
  • Participants do not use tobacco products or any illicit drugs.
  • Participants have not used antibiotics or probiotics in the last month.
  • Participants do not have dietary restrictions prohibiting them from consuming the fiber supplement (e.g., food allergies/intolerance).
  • Participants do not have a pacemaker.
  • Participants are able to lie on their back (supine position) in the dark for at least 10 minutes (related to vascular measurements).

Exclusion Criteria:

  • Participants are not 18-55 years old.
  • Participants BMI is not ≥30 kg/m2 - this BMI requirement is due to our research aims.
  • 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.
  • Participants are pregnant or expecting to become pregnant (females only).
  • Participants are postmenopausal (females only).
  • Participants have been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).
  • 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.
  • Participants take weight-loss medications (e.g., Ozempic, Wegovy).
  • Participants use tobacco products or any illicit drugs.
  • Participants have used antibiotics or probiotics in the last month.
  • Participants have dietary restrictions prohibiting them from consuming the fiber supplement (e.g., food allergies/intolerance).
  • Participants have a pacemaker.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Inulin Supplement

Participants will consume 6g of pre-portioned powdered inulin from chicory root daily for one week followed by 12g daily for eight weeks. Participants will fully dissolve it into a habitual cool or room temperature beverage to drink around the same time each day.

Interventions

inulin

6g inulin from chicory root per day for one week and 12g inulin per day for eight weeks dissolved into cool or room temperature liquid

Primary outcome measure

  • Serum Soluble Cluster of Differentiation 14 (sCD14) [ Time Frame: Through study completion, up to 1.5 years. ]
  • Serum Lipopolysaccharide Binding Protein (LBP) [ Time Frame: Through study completion, up to 1.5 years. ]
  • Serum C-Reactive Protein (CRP) [ Time Frame: Through study completion, up to 1.5 years. ]
  • Heart Rate Variability (HRV) [ Time Frame: Through study completion, up to 1.5 years. ]
  • Flow-Mediated Dilation (FMD) [ Time Frame: Through study completion, up to 1.5 years. ]
  • Pulse Wave Velocity (PWV) [ Time Frame: Through study completion, up to 1.5 years. ]
  • Aortic Aumentation [ Time Frame: Through study completion, up to 1.5 years. ]
  • Augmentation Index (AIx) [ Time Frame: Through study completion, up to 1.5 years. ]

Central Contacts and Locations

Central contacts

Bryant Keirns, PhD

765-285-8356bryant.keirns@bsu.edu

Locations

Health Professions Building

Recruiting

Muncie, Indiana, United States, 47306

Contacts

Bryant Keirns, PhD

765-285-8356bryant.keirns@bsu.edu

More Information

Sponsor

Ball State University

Last update posted

Jul 31, 2025

Last verified

Jul, 2025

Keywords

  • fiber
  • vascular health
  • gut health
  • inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ball State University on 2025-07-31.