Metabolic SyndromeNCT07095426
Impact of Supplemental Fiber on Gut and Vascular Health Related in Obesity Phenotypes
A study testing inulin in people with Metabolic Syndrome and Healthy Participants, run by Ball State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Healthy Participants, Metabolically Healthy Obesity
- What is being tested?
- inulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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).
Who cannot join
- 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).
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Health Professions Building
Muncie, Indiana, 47306
Bryant Keirns, PhD, 765-285-8356, bryant.keirns@bsu.edu
About this study
Official title: Interplay Between Metabolic Risk Factors, Body Mass Index, and the Gut/Vascular Response to Supplemental Fiber
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.
Read the detailed description
The investigators will recruit individuals with obesity (body mass index ≥30 kg/m2) from Ball State University Campus and the surrounding community. Participants will be grouped as "metabolically healthy" (0-1 metabolic syndrome risk factors) or "metabolically unhealthy" (≥2 metabolic syndrome risk factors) Participants will be asked to consume inulin for 9 weeks total. Participants will consume 6g of inulin per day during week 1 as a run-in period. The following 8 weeks participants will consume 12g of inulin per day.
Participants will be asked to report for in-lab assessments/visits before the study begins (baseline), halfway through the intervention which starts following the 1-week run-in period (5 weeks), and at the conclusion of the intervention (9 weeks). At all of these assessments, participants will arrive in the morning (roughly 6-10 AM) having fasted for ~10 hours. We will then collect a blood sample, followed by several vascular measurements including flow-mediated dilation, pulse wave analysis, pulse wave velocity, and an electrocardiogram. Body weight and composition will also be assessed using a bioimpedance scale at each visit. Upon completion of each in-lab visit, participants will be asked to wear an ambulatory blood pressure monitoring device for 24 hours and will complete a 3-day food record. Dual-energy X-ray absorptiometry scans will be used to assess body composition at baseline and final study visits. Participants will provide a stool sample collected at home following baseline and final study visits as an optional procedure.
- Conditions
- Metabolic Syndrome, Healthy Participants, Metabolically Healthy Obesity, Metabolically Abnormal Obesity
- Being tested
- inulin
- Keywords
- fiber, vascular health, gut health, inflammation
- Medical subject headings
- Metabolic Syndrome, Obesity, Metabolically Benign, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inulinDietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| Inulin Supplement | Experimental | Participants will consume 6g of pre-portioned powdered inulin from chicory root daily for one week followed by 12g daily for eight weeks. Participants will fully dissolve it into a habitual cool or room temperature beverage to drink around the same time each day. Receives: Dietary Supplement: inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Soluble Cluster of Differentiation 14 (sCD14)
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.
Measured: Through study completion, up to 1.5 years.
Serum Lipopolysaccharide Binding Protein (LBP)
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.
Measured: Through study completion, up to 1.5 years.
Serum C-Reactive Protein (CRP)
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.
Measured: Through study completion, up to 1.5 years.
Heart Rate Variability (HRV)
The investigators will measure HRV at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through study completion, up to 1.5 years.
Flow-Mediated Dilation (FMD)
The investigators will measure FMD at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through study completion, up to 1.5 years.
Pulse Wave Velocity (PWV)
The investigators will measure PWV at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through study completion, up to 1.5 years.
Aortic Aumentation
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.
Measured: Through study completion, up to 1.5 years.
Augmentation Index (AIx)
The investigators will measure AIx at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through study completion, up to 1.5 years.
Secondary outcomes (5)
Blood Pressure
The investigators will measure peripheral, central, and ambulatory blood pressure at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through study completion, up to 1.5 years.
Glucose
The investigators will measure fasting glucose at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through study completion, up to 1.5 years.
High-Density Lipoprotein Cholesterol (HDL-C)
The investigators will measure fasting HDL-C at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through study completion, up to 1.5 years.
Triglycerides
The investigators will measure fasting triglycerides at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through study completion, up to 1.5 years.
Digestive Symptoms
The investigators will measure digestive symptoms at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through study completion, up to 1.5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start20 May 2025
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open label
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ball State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryant Keirns, Ball State University
- Investigators
- Bryant Keirns, PhD, Principal investigator, Ball State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095426
- Sponsor's protocol ID
- IRB-FY2025-75
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interplay Between Metabolic Risk Factors, Body Mass Index, and the Gut/Vascular Response to Supplemental Fiber
- ClinicalTrials.gov ID
- NCT07095426
- Acronym / sponsor ID
- IRB-FY2025-75
- Conditions
- Metabolic Syndrome, Healthy Participants, Metabolically Healthy Obesity, Metabolically Abnormal Obesity
- Keywords
- fiber, vascular health, gut health, inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ball State UniversityUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will recruit individuals with obesity (body mass index ≥30 kg/m2) from Ball State University Campus and the surrounding community. Participants will be grouped as "metabolically healthy" (0-1 metabolic syndrome risk factors) or "metabolically unhealthy" (≥2 metabolic syndrome risk factors) Participants will be asked to consume inulin for 9 weeks total. Participants will consume 6g of inulin per day during week 1 as a run-in period. The following 8 weeks participants will consume 12g of inulin per day.
Participants will be asked to report for in-lab assessments/visits before the study begins (baseline), halfway through the intervention which starts following the 1-week run-in period (5 weeks), and at the conclusion of the intervention (9 weeks). At all of these assessments, participants will arrive in the morning (roughly 6-10 AM) having fasted for ~10 hours. We will then collect a blood sample, followed by several vascular measurements including flow-mediated dilation, pulse wave analysis, pulse wave velocity, and an electrocardiogram. Body weight and composition will also be assessed using a bioimpedance scale at each visit. Upon completion of each in-lab visit, participants will be asked to wear an ambulatory blood pressure monitoring device for 24 hours and will complete a 3-day food record. Dual-energy X-ray absorptiometry scans will be used to assess body composition at baseline and final study visits. Participants will provide a stool sample collected at home following baseline and final study visits as an optional procedure.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open label
| Arm | Type | Receives |
|---|---|---|
| Inulin Supplement | Experimental | Dietary Supplement: inulinParticipants will consume 6g of pre-portioned powdered inulin from chicory root daily for one week followed by 12g daily for eight weeks. Participants will fully dissolve it into a habitual cool or room temperature beverage to drink around the same time each day. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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).
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inulin6g inulin from chicory root per day for one week and 12g inulin per day for eight weeks dissolved into cool or room temperature liquid | Dietary supplement | Inulin Supplement |
Primary outcome
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.
5 secondary outcomes
Blood Pressure
Time frame: Through study completion, up to 1.5 years.
Glucose
Time frame: Through study completion, up to 1.5 years.
High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Through study completion, up to 1.5 years.
Triglycerides
Time frame: Through study completion, up to 1.5 years.
Digestive Symptoms
Time frame: Through study completion, up to 1.5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bryant Keirns, PhD principal investigator
Ball State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inulin in people with Metabolic Syndrome and Healthy Participants, run by Ball State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryant Keirns, PhD (765-285-8356, bryant.keirns@bsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Soluble Cluster of Differentiation 14 (sCD14) (time frame: Through study completion, up to 1.5 years.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.