Health Professions Building
Muncie, Indiana, 47306, United States
Location status: Recruiting
NCT Number: NCT07095426
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.
Interested in participating?
Request Info18 year–55 year
All sexes
Interventional
Not applicable
Muncie, Indiana, 47306, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through 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.
Time frame: 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.
Time frame: Through study completion, up to 1.5 years.
The investigators will measure peripheral, central, and ambulatory blood pressure at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Time frame: Through study completion, up to 1.5 years.
The investigators will measure fasting glucose at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Time frame: Through study completion, up to 1.5 years.
The investigators will measure fasting HDL-C at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Time frame: Through study completion, up to 1.5 years.
The investigators will measure fasting triglycerides at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Time frame: Through study completion, up to 1.5 years.
The investigators will measure digestive symptoms at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Time frame: Through study completion, up to 1.5 years.
The investigators will measure body composition using bioelectrical impedance and waist circumference at each visit, and dual-energy X-ray absorptiometry at the baseline and final visits. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Contact information is provided by the study sponsor or research team.
Ball State University
Other
Interplay Between Metabolic Risk Factors, Body Mass Index, and the Gut/Vascular Response to Supplemental Fiber
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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