NCT07095426Recruiting
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
Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 24 Jul 2025
- Start date
- May 2025
- Primary completion date
- Nov 2026
- Lead sponsor
- Ball State University
- Diseases
- Obesity
- NCT number
- NCT07095426
What you commit to
- Study type: Interventional
- Planned participants: 20
- From May 2025 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants take weight-loss medications (e.g., Ozempic, Wegovy).
- Participants use tobacco products or any illicit drugs.
Other illness
- 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 have dietary restrictions prohibiting them from consuming the fiber supplement (e.g., food allergies/intolerance).
Age
- Participants are not 18-55 years old.
Other
- 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 used antibiotics or probiotics in the last month.
- Participants have a pacemaker.
Who the study is looking for
- 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).
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Health Professions Building Coordinator of this site? Confirm its status | Muncie | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.