NCT07095426

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ball State University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The investigators will recruit individuals with obesity (body mass index ≥30 kg/m2) from Ball State University Campus and the surrounding community. Participants will be grouped as "metabolically healthy" (0-1 metabolic syndrome risk factors) or "metabolically unhealthy" (≥2 metabolic syndrome risk factors) Participants will be asked to consume inulin for 9 weeks total. Participants will consume 6g of inulin per day during week 1 as a run-in period. The following 8 weeks participants will consume 12g of inulin per day. Participants will be asked to report for in-lab assessments/visits before the study begins (baseline), halfway through the intervention which starts following the 1-week run-in period (5 weeks), and at the conclusion of the intervention (9 weeks). At all of these assessments, participants will arrive in the morning (roughly 6-10 AM) having fasted for \~10 hours. We will then collect a blood sample, followed by several vascular measurements including flow-mediated dilation, pulse wave analysis, pulse wave velocity, and an electrocardiogram. Body weight and composition will also be assessed using a bioimpedance scale at each visit. Upon completion of each in-lab visit, participants will be asked to wear an ambulatory blood pressure monitoring device for 24 hours and will complete a 3-day food record. Dual-energy X-ray absorptiometry scans will be used to assess body composition at baseline and final study visits. Participants will provide a stool sample collected at home following baseline and final study visits as an optional procedure.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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

Timeline

• Start date: 2025-05-20
• Primary completion: 2026-11-01
• Completion: 2027-05-01
• First posted: 2025-07-31
• Last updated: 2025-07-31

Locations

1 site across 1 country: United States