RecruitingNot Applicable

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

United States20 participantsStarted 2025-05-20

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

What they're measuring

Serum Soluble Cluster of Differentiation 14 (sCD14)

Timeframe: Through study completion, up to 1.5 years.

Serum Lipopolysaccharide Binding Protein (LBP)

Timeframe: Through study completion, up to 1.5 years.

Serum C-Reactive Protein (CRP)

Timeframe: Through study completion, up to 1.5 years.

Heart Rate Variability (HRV)

Timeframe: Through study completion, up to 1.5 years.

Flow-Mediated Dilation (FMD)

Timeframe: Through study completion, up to 1.5 years.

Pulse Wave Velocity (PWV)

Timeframe: Through study completion, up to 1.5 years.

Aortic Aumentation

Timeframe: Through study completion, up to 1.5 years.

Augmentation Index (AIx)

Timeframe: Through study completion, up to 1.5 years.

Trial details

NCT IDNCT07095426

SponsorBall State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11

Contact for this trial

Bryant Keirns, PhD

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

View on ClinicalTrials.gov More Metabolic Syndrome trials

Plain-language summary

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Serum Soluble Cluster of Differentiation 14 (sCD14)

Timeframe: Through study completion, up to 1.5 years.

Serum Lipopolysaccharide Binding Protein (LBP)

Timeframe: Through study completion, up to 1.5 years.

Serum C-Reactive Protein (CRP)

Timeframe: Through study completion, up to 1.5 years.

Heart Rate Variability (HRV)

Timeframe: Through study completion, up to 1.5 years.

Flow-Mediated Dilation (FMD)

Timeframe: Through study completion, up to 1.5 years.

Pulse Wave Velocity (PWV)

Timeframe: Through study completion, up to 1.5 years.

Aortic Aumentation

Timeframe: Through study completion, up to 1.5 years.

Augmentation Index (AIx)

Timeframe: Through study completion, up to 1.5 years.