NCT07095426 Impact of Supplemental Fiber on Gut and Vascular Health Related in Obesity Phenotypes
| NCT ID | NCT07095426 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ball State University |
| Condition | Metabolic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-05-20 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Bryant Keirns, PhD
PRINCIPAL INVESTIGATOR
Ball State University
Frequently Asked Questions
Who can join the NCT07095426 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Metabolic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07095426 currently recruiting?
Yes, NCT07095426 is actively recruiting participants. Contact the research team at bryant.keirns@bsu.edu for enrollment information.
Where is the NCT07095426 trial being conducted?
This trial is being conducted at Muncie, United States.
Who is sponsoring the NCT07095426 clinical trial?
NCT07095426 is sponsored by Ball State University. The principal investigator is Bryant Keirns, PhD at Ball State University. The trial plans to enroll 20 participants.