Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07095426

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 55 Years
SexAll
Healthy volunteersAccepted
ConditionMetabolic Syndrome, Healthy Participants, Metabolically Healthy Obesity, Metabolically Abnormal Obesity

Full registry criteria

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.

Treatments and study arms

inulin

Dietary Supplement

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 outcomes

Serum Soluble Cluster of Differentiation 14 (sCD14)Through study completion, up to 1.5 years.

The investigators will measure fasting sCD14 at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

Serum Lipopolysaccharide Binding Protein (LBP)Through study completion, up to 1.5 years.

The investigators will measure fasting LBP at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

Serum C-Reactive Protein (CRP)Through study completion, up to 1.5 years.

The investigators will measure fasting CRP at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

Heart Rate Variability (HRV)Through study completion, up to 1.5 years.

The investigators will measure HRV at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

Flow-Mediated Dilation (FMD)Through study completion, up to 1.5 years.

The investigators will measure FMD at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

Pulse Wave Velocity (PWV)Through study completion, up to 1.5 years.

The investigators will measure PWV at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

Aortic AumentationThrough study completion, up to 1.5 years.

The investigators will measure aortic augmentation at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

Augmentation Index (AIx)Through study completion, up to 1.5 years.

The investigators will measure AIx at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Health Professions Building🇺🇸 Muncie, Indiana, United States
Bryant Keirns, PhDContact