Metabolically Healthy ObesityNCT07559227
Gut, Immune, and Vascular Health in Metabolically Healthy Obesity
A study testing Inulin Supplementation and High-fat meal in people with Metabolically Healthy Obesity, run by Ball State University at 1 site in United States.
Trial summary
The investigators seek to better understand how a single high-fat meal impacts gut, immune, and vascular outcomes in individuals with "metabolically healthy obesity" (obesity and largely normal cardiometabolic profile) and "metabolically healthy normal-weight individuals." Second, the investigators seek to understand… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolically Healthy Obesity
- What is being tested?
- Inulin Supplementation and High-fat meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to Dec 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
- 18-55 years old.
- BMI is 18.5-24.9 kg/m2 or >30kg/m2 (part 1). BMI > 30 kg/m2 (part 2)
- Not pregnant or expecting to become pregnant (females only).
- Not postmenopausal (females only).
- Have 0-1 risk factors based on blood pressure, blood sugar, triglycerides, and HDL-cholesterol ("good cholesterol").
- Have not been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).
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- Have not been diagnosed with a chronic inflammatory or gastrointestinal condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
- Do not regularly take anti-inflammatory drugs (more than 2x week) or are able to temporarily suspend use of anti-inflammatory drugs three days prior to the study visit.
- Have not taken antibiotics or probiotics in the last month.
- Do not use lipid-lowering drugs (e.g., statins), glucose-lowering drugs (e.g., metformin), or anti-hypertensive drugs.
- Do not use weight-loss drugs (e.g., Ozempic, Wegovy).
- Have not had any surgery that alters the stomach/gastrointestinal tract (e.g., gastric sleeve, gastric bypass).
- Do not use tobacco products or any illicit drugs.
- Do not have a pacemaker.
- Do not have dietary restrictions prohibiting consumption of the provided meal (e.g., vegan/vegetarian diets, gluten-free diet, relevant food allergies).
- Able to stay in the supine position in the dark for at least 10 minutes (related to vascular measurements)
Who cannot join
- Not 18-55 years old.
- BMI is not 18.5-24.9 kg/m2 or >30kg/m2 (part 1). BMI is not > 30 kg/m2 (part 2)
- Pregnant or expecting to become pregnant (females only).
- Postmenopausal (females only).
- Do not have 0-1 risk factors based on blood pressure, blood sugar, triglycerides, and HDL-cholesterol ("good cholesterol").
- Have been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).
Show all 16Show fewer
- Have been diagnosed with a chronic inflammatory or gastrointestinal condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
- Regularly take anti-inflammatory drugs (more than 2x week) or are unable to temporarily suspend use of anti-inflammatory drugs three days prior to the study visit.
- Have taken antibiotics or probiotics in the last month.
- Use lipid-lowering drugs (e.g., statins), glucose-lowering drugs (e.g., metformin), or anti-hypertensive drugs.
- Use weight-loss drugs (e.g., Ozempic, Wegovy).
- Have had any surgery that alters the stomach/gastrointestinal tract (e.g., gastric sleeve, gastric bypass).
- Use tobacco products or any illicit drugs.
- Have a pacemaker.
- Have dietary restrictions prohibiting consumption of the provided meal (e.g., vegan/vegetarian diets, gluten-free diet, relevant food allergies).
- Not able to stay in the supine position in the dark for at least 10 minutes (related to vascular measurements)
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
About this study
Official title: Impaired Gut-Vascular Axis as a Unique Driver of Cardiovascular Disease in Metabolically Healthy Obesity
The investigators seek to better understand how a single high-fat meal impacts gut, immune, and vascular outcomes in individuals with "metabolically healthy obesity" (obesity and largely normal cardiometabolic profile) and "metabolically healthy normal-weight individuals." Second, the investigators seek to understand how a prebiotic fiber (inulin) impacts gut, immune, and vascular outcomes in individuals with "metabolically healthy obesity."
Read the detailed description
This study consists of two parts (part 1 and part 2) that are approved under the same IRB approval code. As a result, there is only one unique identifier for the entirety of this project. As a results, the investigators have included both parts in this registration.
Part 1 of project:
The investigators will recruit individuals with a BMI in the normal (18.5-24.9 kg/m2) or obesity (>30.0 kg/m2) ranges from the Ball State University campus and surrounding communities. At a screening visit, the investigators will measure metabolic syndrome risk (blood pressure, triglycerides, glucose, HDL-C) to see if individuals meet criteria for "metabolically healthy obesity" and "metabolically healthy normal-weight" - our two groups of interest.
Each participant will complete one meal trial. At the meal trial, an intravenous catheter will be inserted and baseline blood sample collected. Next, vascular assessments (i.e., flow mediated dilation [FMD], pulse wave analysis [PWA], pulse wave velocity [PWV]) will be completed. Then, participants will consume the high-fat meal consisting of heavy cream, chocolate syrup, and protein powder. The meal will contain ~700 calories (55g fat).
Following completion of the meal, blood samples will also be collected at 1-, 2-, 3-, 4-, 5-, and 6-hours. At each time point the investigators will collect serum to assess biomarkers of intestinal permeability and inflammation. Serum will also be used in mechanistic experiments where the investigators will treat endothelial cells in culture with serum from participants pre/post high-fat meal and examine differences in gene and protein expression, as well as nitric oxide production. Additional blood will be collected for peripheral blood mononuclear cell isolation at baseline and 3 hours. Vascular assessments listed above will be repeated at 2-, 4-, and 6-hours.
Participants will provide a stool sample collected at home for microbiome analyses.
Part 2 of project:
The investigators will recruit individuals with a BMI in the obesity (>30.0 kg/m2) range from the Ball State University campus and surrounding communities. At a screening visit, the investigators will measure metabolic syndrome risk (blood pressure, triglycerides, glucose, HDL-C) to see if individuals meet criteria for "metabolically healthy obesity" - our sole group of interest.
Qualifying participants will report for a baseline assessment. At the baseline assessment, the investigators will collect fasting blood samples to assess biomarkers related to gut, immune, and vascular health. Serum will also be used in mechanistic experiments where the investigators will treat endothelial cells in culture with serum from participants pre/post intervention and examine differences in gene and protein expression, as well as nitric oxide production. Next, vascular assessments (i.e., flow mediated dilation [FMD], pulse wave analysis [PWA], pulse wave velocity [PWV]) will be completed. This will conclude data collection and participants will be randomized to receive 6 weeks of supplemental inulin (a soluble fiber) or a placebo (maltodextrin). At 2-, 4-, and 6-weeks of the intervention, the same samples and measurements will be collected at in-lab visits. Stool samples will be collected at baseline and 6 weeks.
- Conditions
- Metabolically Healthy Obesity
- Being tested
- Inulin Supplementation, Maltodextrin (Placebo), High-fat meal
- Keywords
- Gut-vascular axis, Intestinal permeability, vascular function, obesity
- Medical subject headings
- Obesity, Metabolically Benign, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inulin SupplementationDietary supplement
Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).
Maltodextrin (Placebo)Dietary supplement
Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).
High-fat mealOther
All participants in part 1 (both metabolically healthy normal weight and metabolically healthy obesity) will consume a high-fat meal designed to invoke changes in gut, immune, and vascular parameters.
| Study group | Role | What they receive |
|---|---|---|
| Metabolically Healthy Obesity Group | Experimental | Individuals with a body mass index greater than 30 kg/m2 and 0-1 of the following risk factors: blood pressure >130/85 mmHg, triglycerides > 150 mg/dL, glucose > 100 mg/dL, and HDL-C < 50 (females) or < 40 (males). Receives: Dietary Supplement: Inulin Supplementation; Dietary Supplement: Maltodextrin (Placebo); Other: High-fat meal |
| Metabolically Healthy Normal Weight Group | Active comparator | Individuals with a body mass index between 18.5-24.9 kg/m2 and 0-1 of the following risk factors: blood pressure >130/85 mmHg, triglycerides > 150 mg/dL, glucose > 100 mg/dL, and HDL-C < 50 (females) or < 40 (males). Receives: Other: High-fat meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum lipopolysaccharide binding protein
Part 1: The investigators will measure lipopolysaccharide binding protein at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal.
Part 2: The investigators will measure lipopolysaccharide binding protein at baseline and 2-, 4-, and 6-weeks post intervention.
Measured: Through study completion, up to 2 years
Serum interleukin-6
Part 1: The investigators will measure interleukin-6 at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal.
Part 2: The investigators will measure interleukin-6 at baseline and 2-, 4-, and 6-weeks post intervention.
Measured: Through study completion, up to 2 years.
Flow-mediated dilation
Part 1: The investigators will measure flow-mediated dilation at baseline and 2-, 4-, 6-hours after the meal. Part 2: The investigators will measure flow-mediated dilation at baseline and 2-, 4-, and 6-weeks post intervention.
Measured: Through study completion, up to 2 years
Serum C reactive protein
Part 2: The investigators will measure C reactive protein at baseline and 2-, 4-, and 6-weeks post intervention.
Measured: Through study completion, up to 2 years
Serum lipopolysaccharide
Part 1: The investigators will measure lipopolysaccharide at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure lipopolysaccharide at baseline and 2-, 4-, and 6-weeks post intervention.
Measured: Through study completion, up to 2 years
Serum TNF-alpha
The investigators will measure serum TNF-alpha at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure TNF-alpha at baseline and 2-, 4-, and 6-weeks post intervention.
Measured: Through study completion, up to 2 years
Serum zonulin
Part 2: The investigators will measure serum zonulin at baseline and 2-, 4-, and 6-weeks post intervention.
Measured: Through study completion, up to 2 years.
Secondary outcomes (10)
Augmentation Index
Part 1: The investigators will measure augmentation index at baseline and 2-, 4-, 6-hours after the meal. Part 2: The investigators will measure augmentation index at baseline and 2-, 4-, and 6-weeks post intervention.
Measured: Through study completion, up to 2 years
Pulse-wave velocity
Part 1: The investigators will measure pulse-wave velocity at baseline and 2-, 4-, 6-hours after the meal. Part 2: The investigators will measure pulse wave velocity at baseline and 2-, 4-, and 6-weeks post intervention.
Measured: Through study completion, up to 2 years
Serum soluble CD14
Part 1: The investigators will measure serum soluble CD14 at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure serum soluble sCD14 at baseline and 2-, 4-, and 6-weeks post intervention.
Measured: Through study completion, up to 2 years
Serum IL-1 beta
Part 1: The investigators will measure serum IL-1 beta at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure serum IL-1beta at baseline and 2-, 4-, and 6-weeks post intervention.
Measured: Through study completion, up to 2 years
Serum soluble VCAM-1
Part 1: The investigators will measure serum soluble VCAM-1 at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal.
Measured: Through study completion, up to 2 years
Peripheral blood mononuclear cell transcriptome
Part 1: The investigators will measure interleukin-6 at baseline and 3-hours after the meal.
Measured: Through study completion, up to 2 years
Serum treated HAEC transcriptome
Part 1: The investigators will measure the HAEC transcriptome after treatment with baseline and 2-, 4-, 6-hour post-meal serum. Part 2: The investigators will measure the HAEC transcriptome after treatment with serum from baseline and 2-, 4-, and 6-weeks post intervention.
Measured: Through study completion, up to 2 years
Serum treated HAEC eNOS and NFkB protein expression
Part 1: The investigators will measure HAEC eNOS and NFkB protein expression after treatment with baseline and 2-, 4-, 6-hour post-meal serum. Part 2: The investigators will measure HAEC eNOS and NFkB protein expression after treatment with serum from baseline and 2-, 4-, and 6-weeks post intervention.
Measured: Through study completion, up to 2 years
Microbiome composition (shotgun sequencing)
Part 1: The investigators will determine microbiome composition once within one week of participants completing the meal trial. Part 2: The investigators will measure microbiome composition at baseline and 6-weeks post intervention.
Measured: Through study completion, up to 2 years
Serum treated HAEC nitric oxide production
Part 1: The investigators will measure the HAEC nitric oxide production after treatment with baseline and 2-, 4-, 6-hour post-meal serum. Part 2: The investigators will measure HAEC nitric oxide production after treatment with serum from baseline and 2-, 4-, and 6-weeks post intervention.
Measured: Through study completion, up to two years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolically Healthy ObesityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- In part 1 of the study, all participants (n=20 with metabolically healthy obesity and n=20 with metabolically healthy normal weight) will consume a single high-fat meal. There is no randomization. In part 2 of the study, metabolically healthy obese individuals (n=30) will be randomized to consume supplemental inulin or maltodextrin (placebo) for 6 weeks. The present project is approved under one IRB application, so the investigators are unable to separate part 1 and part 2 into two CT.gov entries. The investigators have selected "randomized" below, but in reality there is no randomization procedures in part 1.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 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
- NCT07559227
- Sponsor's protocol ID
- IRB-FY2026-239
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: ClinicalTrials.gov NCBI BioProject NCBI Reference Sequence Open Science Framework (general) Sequence Read Archive (SRA)
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impaired Gut-Vascular Axis as a Unique Driver of Cardiovascular Disease in Metabolically Healthy Obesity
- ClinicalTrials.gov ID
- NCT07559227
- Acronym / sponsor ID
- IRB-FY2026-239
- Conditions
- Metabolically Healthy Obesity
- Keywords
- Gut-vascular axis, Intestinal permeability, vascular function, obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ball State UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Apr 2026 (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.
The investigators seek to better understand how a single high-fat meal impacts gut, immune, and vascular outcomes in individuals with "metabolically healthy obesity" (obesity and largely normal cardiometabolic profile) and "metabolically healthy normal-weight individuals." Second, the investigators seek to understand how a prebiotic fiber (inulin) impacts gut, immune, and vascular outcomes in individuals with "metabolically healthy obesity."
Detailed description
This study consists of two parts (part 1 and part 2) that are approved under the same IRB approval code. As a result, there is only one unique identifier for the entirety of this project. As a results, the investigators have included both parts in this registration.
Part 1 of project:
The investigators will recruit individuals with a BMI in the normal (18.5-24.9 kg/m2) or obesity (>30.0 kg/m2) ranges from the Ball State University campus and surrounding communities. At a screening visit, the investigators will measure metabolic syndrome risk (blood pressure, triglycerides, glucose, HDL-C) to see if individuals meet criteria for "metabolically healthy obesity" and "metabolically healthy normal-weight" - our two groups of interest.
Each participant will complete one meal trial. At the meal trial, an intravenous catheter will be inserted and baseline blood sample collected. Next, vascular assessments (i.e., flow mediated dilation [FMD], pulse wave analysis [PWA], pulse wave velocity [PWV]) will be completed. Then, participants will consume the high-fat meal consisting of heavy cream, chocolate syrup, and protein powder. The meal will contain ~700 calories (55g fat).
Following completion of the meal, blood samples will also be collected at 1-, 2-, 3-, 4-, 5-, and 6-hours. At each time point the investigators will collect serum to assess biomarkers of intestinal permeability and inflammation. Serum will also be used in mechanistic experiments where the investigators will treat endothelial cells in culture with serum from participants pre/post high-fat meal and examine differences in gene and protein expression, as well as nitric oxide production. Additional blood will be collected for peripheral blood mononuclear cell isolation at baseline and 3 hours. Vascular assessments listed above will be repeated at 2-, 4-, and 6-hours.
Participants will provide a stool sample collected at home for microbiome analyses.
Part 2 of project:
The investigators will recruit individuals with a BMI in the obesity (>30.0 kg/m2) range from the Ball State University campus and surrounding communities. At a screening visit, the investigators will measure metabolic syndrome risk (blood pressure, triglycerides, glucose, HDL-C) to see if individuals meet criteria for "metabolically healthy obesity" - our sole group of interest.
Qualifying participants will report for a baseline assessment. At the baseline assessment, the investigators will collect fasting blood samples to assess biomarkers related to gut, immune, and vascular health. Serum will also be used in mechanistic experiments where the investigators will treat endothelial cells in culture with serum from participants pre/post intervention and examine differences in gene and protein expression, as well as nitric oxide production. Next, vascular assessments (i.e., flow mediated dilation [FMD], pulse wave analysis [PWA], pulse wave velocity [PWV]) will be completed. This will conclude data collection and participants will be randomized to receive 6 weeks of supplemental inulin (a soluble fiber) or a placebo (maltodextrin). At 2-, 4-, and 6-weeks of the intervention, the same samples and measurements will be collected at in-lab visits. Stool samples will be collected at baseline and 6 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In part 1 of the study, all participants (n=20 with metabolically healthy obesity and n=20 with metabolically healthy normal weight) will consume a single high-fat meal. There is no randomization. In part 2 of the study, metabolically healthy obese individuals (n=30) will be randomized to consume supplemental inulin or maltodextrin (placebo) for 6 weeks. The present project is approved under one IRB application, so the investigators are unable to separate part 1 and part 2 into two CT.gov entries. The investigators have selected "randomized" below, but in reality there is no randomization procedures in part 1.
| Arm | Type | Receives |
|---|---|---|
| Metabolically Healthy Obesity Group | Experimental | Dietary Supplement: Inulin Supplementation, Dietary Supplement: Maltodextrin (Placebo), Other: High-fat mealIndividuals with a body mass index greater than 30 kg/m2 and 0-1 of the following risk factors: blood pressure >130/85 mmHg, triglycerides > 150 mg/dL, glucose > 100 mg/dL, and HDL-C < 50 (females) or < 40 (males). |
| Metabolically Healthy Normal Weight Group | Active comparator | Other: High-fat mealIndividuals with a body mass index between 18.5-24.9 kg/m2 and 0-1 of the following risk factors: blood pressure >130/85 mmHg, triglycerides > 150 mg/dL, glucose > 100 mg/dL, and HDL-C < 50 (females) or < 40 (males). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 18-55 years old.
- BMI is 18.5-24.9 kg/m2 or >30kg/m2 (part 1). BMI > 30 kg/m2 (part 2)
- Not pregnant or expecting to become pregnant (females only).
- Not postmenopausal (females only).
- Have 0-1 risk factors based on blood pressure, blood sugar, triglycerides, and HDL-cholesterol ("good cholesterol").
Key exclusion criteria (16 listed)
- Not 18-55 years old.
- BMI is not 18.5-24.9 kg/m2 or >30kg/m2 (part 1). BMI is not > 30 kg/m2 (part 2)
- Pregnant or expecting to become pregnant (females only).
- Postmenopausal (females only).
- Do not have 0-1 risk factors based on blood pressure, blood sugar, triglycerides, and HDL-cholesterol ("good cholesterol").
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 |
|---|---|---|
| Inulin SupplementationHalf of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin). | Dietary supplement | Metabolically Healthy Obesity Group |
| Maltodextrin (Placebo)Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin). | Dietary supplement | Metabolically Healthy Obesity Group |
| High-fat mealAll participants in part 1 (both metabolically healthy normal weight and metabolically healthy obesity) will consume a high-fat meal designed to invoke changes in gut, immune, and vascular parameters. | Other | Metabolically Healthy Normal Weight Group, Metabolically Healthy Obesity Group |
Primary outcome
Serum lipopolysaccharide binding protein
Time frame: Through study completion, up to 2 years
Part 1: The investigators will measure lipopolysaccharide binding protein at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure lipopolysaccharide binding protein at baseline and 2-, 4-, and 6-weeks post intervention.
Serum interleukin-6
Time frame: Through study completion, up to 2 years.
Part 1: The investigators will measure interleukin-6 at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure interleukin-6 at baseline and 2-, 4-, and 6-weeks post intervention.
Flow-mediated dilation
Time frame: Through study completion, up to 2 years
Part 1: The investigators will measure flow-mediated dilation at baseline and 2-, 4-, 6-hours after the meal. Part 2: The investigators will measure flow-mediated dilation at baseline and 2-, 4-, and 6-weeks post intervention.
Serum C reactive protein
Time frame: Through study completion, up to 2 years
Part 2: The investigators will measure C reactive protein at baseline and 2-, 4-, and 6-weeks post intervention.
Serum lipopolysaccharide
Time frame: Through study completion, up to 2 years
Part 1: The investigators will measure lipopolysaccharide at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure lipopolysaccharide at baseline and 2-, 4-, and 6-weeks post intervention.
Serum TNF-alpha
Time frame: Through study completion, up to 2 years
The investigators will measure serum TNF-alpha at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure TNF-alpha at baseline and 2-, 4-, and 6-weeks post intervention.
Serum zonulin
Time frame: Through study completion, up to 2 years.
Part 2: The investigators will measure serum zonulin at baseline and 2-, 4-, and 6-weeks post intervention.
10 secondary outcomes
Augmentation Index
Time frame: Through study completion, up to 2 years
Pulse-wave velocity
Time frame: Through study completion, up to 2 years
Serum soluble CD14
Time frame: Through study completion, up to 2 years
Serum IL-1 beta
Time frame: Through study completion, up to 2 years
Serum soluble VCAM-1
Time frame: Through study completion, up to 2 years
Peripheral blood mononuclear cell transcriptome
Time frame: Through study completion, up to 2 years
Serum treated HAEC transcriptome
Time frame: Through study completion, up to 2 years
Serum treated HAEC eNOS and NFkB protein expression
Time frame: Through study completion, up to 2 years
Microbiome composition (shotgun sequencing)
Time frame: Through study completion, up to 2 years
Serum treated HAEC nitric oxide production
Time frame: Through study completion, up to two 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 30 Apr 2026.
- Individual participant dataSharing planned: Yes. ClinicalTrials.gov NCBI BioProject NCBI Reference Sequence Open Science Framework (general) Sequence Read Archive (SRA)
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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 Supplementation and High-fat meal in people with Metabolically Healthy Obesity, 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 16 inclusion and 16 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 30 Apr 2026. 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 lipopolysaccharide binding protein (time frame: Through study completion, up to 2 years). The study lists 7 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 30 Apr 2026.