Supplemental inulin fiber for gut and vascular health in adults with obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.