NCT07095426 · Ball State University
Impact of Supplemental Fiber on Gut and Vascular Health Related in Obesity Phenotypes
What this study is about
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.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
inulin
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
Primary outcome measures
Serum Soluble Cluster of Differentiation 14 (sCD14)
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.
Serum Lipopolysaccharide Binding Protein (LBP)
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.
Serum C-Reactive Protein (CRP)
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.
Heart Rate Variability (HRV)
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.
Flow-Mediated Dilation (FMD)
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.
Pulse Wave Velocity (PWV)
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.
Aortic Aumentation
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.
Augmentation Index (AIx)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Muncie, Indiana
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 31, 2025 · Source of record for eligibility and locations