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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
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• 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).

Locations
United States
Indiana
Health Professions Building
RECRUITING
Muncie
Contact Information
Primary
Bryant Keirns, PhD
bryant.keirns@bsu.edu
765-285-8356
Time Frame
Start Date: 2025-05-20
Estimated Completion Date: 2027-05
Participants
Target number of participants: 20
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Ball State University

This content was sourced from clinicaltrials.gov