Supplemental inulin fiber for gut and vascular health in adults with obesity
Interplay Between Metabolic Risk Factors, Body Mass Index, and the Gut/Vascular Response to Supplemental Fiber
This will try 9 weeks of inulin fiber to see if it improves gut health and blood vessel function in adults with obesity who are either metabolically healthy or metabolically abnormal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Ball State University Academic / other |
| Locations | 1 site (Muncie, Indiana) |
| Trial ID | NCT07095426 on ClinicalTrials.gov |
What this trial studies
The trial enrolls adults aged 18–55 with BMI ≥30 and groups them as metabolically healthy (0–1 metabolic risk factors) or metabolically unhealthy (≥2 risk factors). Participants complete a 1-week run-in of 6 g/day inulin followed by 8 weeks of 12 g/day inulin and attend in-lab visits at baseline, 5 weeks, and 9 weeks. At each fasting visit investigators collect blood, vascular measures (flow-mediated dilation, pulse wave analysis, pulse wave velocity, ECG), body composition, stool samples, and participants wear a 24-hour ambulatory blood pressure monitor; DXA is done at baseline and final visits. The study compares changes in gut-related markers and vascular function between the two obesity phenotypes after fiber supplementation.
Who should consider this trial
Good fit: Ideal candidates are adults 18–55 with BMI ≥30 who are not pregnant or postmenopausal, do not have advanced cardiometabolic or chronic inflammatory diseases, are not using weight-loss drugs, and can follow the dosing and visit schedule.
Not a fit: People with diagnosed cardiovascular disease, type 2 diabetes, chronic inflammatory bowel or autoimmune conditions, those on frequent anti-inflammatory or weight-loss medications, pregnant or postmenopausal women, or those unable to attend in-person visits are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, supplemental inulin could improve gut microbiota and reduce markers of vascular dysfunction, potentially lowering cardiovascular risk in people with obesity.
How similar studies have performed: Prior studies show inulin and other prebiotic fibers can change gut microbiota and improve some metabolic markers, but evidence for consistent improvements in vascular function across populations is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Muncie, Indiana
- Health Professions Building — Muncie, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Bryant Keirns, PhD — Ball State University
- Study coordinator: Bryant Keirns, PhD
- Email: bryant.keirns@bsu.edu
- Phone: 765-285-8356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.