Normal-weight ObesityNCT06818500
Effects of Body Composition on Vascular Health in Females With a Healthy Body Weight
A study testing high-fat meal and Stress in people with Normal-weight Obesity and BMI, run by Ball State University at 1 site in United States.
Trial summary
Most of the time, body weight is evaluated by looking at the ratio of your weight to your height. This measurement is called body mass index or BMI. However, BMI does not account for what your body is actually made up of (e.g., body fat versus muscle), which may be more important for determining cardiovascular disease… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Normal-weight Obesity, BMI, Stress
- What is being tested?
- high-fat meal and Stress
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 31 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- You are 18-50 years old
- Your biological sex is female
- BMI is in "normal" category (18.5-24.9 kg/m2) - this BMI requirement is due to our research aims
- You are not pregnant or expecting to become pregnant
- You are not postmenopausal
- You have not been diagnosed with a cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes)
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- You have not been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
- You do not regularly take anti-inflammatory drugs (more than 2x week) or are able to temporarily suspend use of anti-inflammatory drugs.
- You do not use lipid-lowering drugs (e.g., statins), glucose-lowering drugs (e.g., metformin) tobacco products, or any illicit drugs
- You do not have a pacemaker.
- You do not have dietary restrictions prohibiting you from eating the provided meal (e.g., vegan/vegetarian diets, gluten-free diet, relevant food allergies).
- You are able to stay in the supine position in the dark for at least 10 minutes
Who cannot join
- You are not 18-50 years old
- Your biological sex is not female
- Your BMI is not in the "normal" category (18.5-24.9 kg/m2) - this BMI requirement is due to our research aims
- You are pregnant or expecting to become pregnant (females only)
- You are postmenopausal
- You have been diagnosed with a cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes)
Show all 12Show fewer
- You have been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
- You regularly take anti-inflammatory drugs (more than 2x week) or are unable to temporarily suspend use of anti-inflammatory drugs.
- You use lipid-lowering drugs (e.g., statins), glucose-lowering drugs (e.g., metformin) tobacco products, or any illicit drugs
- You have a pacemaker.
- You do have dietary restrictions prohibiting you from eating the provided meal (e.g., vegan/vegetarian diets, gluten-free diet, relevant food allergies).
- You are unable to stay in the supine position in the dark for at least 10 minutes
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
Ball State University- Nutrition Assessment Lab
Muncie, Indiana, 47303
Bryant H Keirns, PhD, 7652858356, bryant.keirns@bsu.edu
Bryant H Keirns, PhD
About this study
Official title: Resting Indicators of Vascular Health and Cardiovascular Reactivity in Females With "Normal-Weight Obesity"
Most of the time, body weight is evaluated by looking at the ratio of your weight to your height. This measurement is called body mass index or BMI. However, BMI does not account for what your body is actually made up of (e.g., body fat versus muscle), which may be more important for determining cardiovascular disease risk. The investigators aim to understand vascular health in females with a "healthy" BMI with differing amounts of body fat and muscle mass. We will have participants come to the lab for two different study visits. At one visit, participants will eat a meal high in fat, and at the other visit, participants will undergo a stress task.
Read the detailed description
The investigators will recruit females with a BMI in the normal (18.5-24.9 kg/m2) from the Ball State University campus and surrounding communities. Each participant will complete a meal trial and a stress trial in a randomized crossover design. At the meal trial, an intravenous catheter will be inserted and baseline blood sample collected. Then vascular measurements (i.e., flow-mediated dilation, pulse wave analysis, pulse wave velocity) will be performed. Each time vascular measurements are performed, the participants will lie in a quiet area to acclimate prior to beginning. Next, participants will consume a high-fat, Western style meal consisting of two Jimmy Deans Breakfast Bowls (sausage; 68 g fat; 880 kcal). Following completion of the meal, blood samples will also be collected 1, 2, 3, and 4 hours after the meal. Vascular measurements will be repeated 2 and 4 hours after the meal. Blood will be collected and stored as serum in order to measure triglycerides, HDL-C, and intestinal permeability (e.g., lipopolysaccharide binding protein) using commercially available ELISAs.
At the stress trial, an intravenous catheter will be inserted and baseline blood sample collected. Then vascular measurements (i.e., flow-mediated dilation, pulse wave analysis, pulse wave velocity) will be performed. Each time vascular measurements are performed, the participants will lie in a quiet area to acclimate prior to beginning. Next, participants will undergo the stress task. Then, blood samples will be collected at 10, 60, and 90 minutes after the stress task. Blood will be collected and stored as serum in order to measure epinephrine and inflammatory markers. Vascular measurements will also be repeated 10 and 90 minutes after the stress task.
- Conditions
- Normal-weight Obesity, BMI, Stress
- Being tested
- high-fat meal, Stress
- Keywords
- BMI, Stress, Healthy BMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-fat mealOther
Participants will report fasted and consume two Jimmy Dean breakfast bowls (sausage).
StressOther
Participants will report fasted and undergo a mental stress task.
| Study group | Role | What they receive |
|---|---|---|
| High-fat meal trial | Experimental | During the "High-fat meal trial", participants will report fasted and consume two Jimmy Dean's breakfast bowls. Receives: Other: high-fat meal |
| Stress trial | Experimental | During the "Stress trial", participants will report fasted and undergo a stress task where they may experience mental stress. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation
The investigators will measure FMD at baseline, 2-hours, and 4-hours after meal trial. The investigators will measure FMD at baseline, post-stress task, and 90-minutes after the stress task.
Measured: Through study completion, up to 1 year.
Pulse wave analysis
The investigators will measure PWA (i.e., augmentation index, augmentation index normalized to a heart rate of 75bpm, aortic/peripheral blood pressure) at baseline, 2-hours, and 4-hours after meal trial using Sphygmacor Xcel System. The investigators will measure PWA at baseline, post-stress task, and 90-minutes after the stress task.
Measured: Through study completion, up to 1 year.
Pulse wave velocity
The investigators will measure PWV at baseline, 2-hours, and 4-hours after meal trial using the Sphygmacor Xcel System. The investigators will measure PWV at baseline, post-stress task, and 90-minutes after the stress task.
Measured: Through study completion, up to 1 year.
Secondary outcomes (8)
Serum high-density lipoprotein cholesterol (HDL-C)
The investigators will measure HDL-C at baseline and 1, 2, 3, and 4 hours after the meal. Serum will be banked from each visit and this measurement will take place upon study completion.
Measured: Through study completion, up to 1 year.
Serum triglycerides
The investigators will measure triglycerides at baseline and 1, 2, 3, and 4 hours after the meal. Serum will be banked from each visit and this measurement will take place upon study completion.
Measured: Through study completion, up to 1 year.
Serum soluble CD14 (sCD14)
The investigators will measure serum sCD14 at baseline and 1-, 2-, 3-, and 4-hours after the meal. Serum will be banked from each visit and this measurement will take place upon study completion.
Measured: Through study completion, up to 1 year.
Serum lipopolysaccharide binding protein (LBP)
The investigators will measure serum LBP at baseline and 1-, 2-, 3-, and 4-hours after the meal. Serum will be banked from each visit and this measurement will take place upon study completion.
Measured: Through study completion, up to 1 year.
Serum epinephrine
The investigators will measure serum epinephrine at baseline and 10-, 60- and 90-minutes after the stress task. Serum will be banked from each visit and this measurement will take place upon study completion.
Measured: Through study completion, up to 1 year.
Serum interleukin-6 (IL-6)
The investigators will measure serum IL-6 at baseline and 1-, 2-, 3-, and 4-hours after the meal and 10, 60, and 90 minutes after the stress task. Serum will be banked from each visit and this measurement will take place upon study completion.
Measured: Through study completion, up to 1 year.
Heart rate variability (HRV)
The investigator will analyze HRV pre-, during, and post-stress task during the stress trial (Task Force Monitor).
Measured: Through study completion, up to 1 year.
Beat-to-beat systolic and diastolic blood pressure (SBP/DBP)
The investigator will analyze SBP/DBP pre, during, and post-stress task during the stress trial (Task Force Monitor).
Measured: Through study completion, up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Sep 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal-weight 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
- Crossover
- Model description
- We are studying human physiology of cardiovascular health in females with a normal BMI. We will not be using any drug interventions. Instead, participants will eat a high-fat meal at one visit and complete a stress task at the other visit. Vascular responses will be assessed.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ball State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818500
- Sponsor's protocol ID
- 2201237-1
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting Indicators of Vascular Health and Cardiovascular Reactivity in Females With "Normal-Weight Obesity"
- ClinicalTrials.gov ID
- NCT06818500
- Acronym / sponsor ID
- 2201237-1
- Conditions
- Normal-weight Obesity, BMI, Stress
- Keywords
- BMI, Stress, Healthy BMI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ball State UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 10 Feb 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.
Most of the time, body weight is evaluated by looking at the ratio of your weight to your height. This measurement is called body mass index or BMI. However, BMI does not account for what your body is actually made up of (e.g., body fat versus muscle), which may be more important for determining cardiovascular disease risk. The investigators aim to understand vascular health in females with a "healthy" BMI with differing amounts of body fat and muscle mass. We will have participants come to the lab for two different study visits. At one visit, participants will eat a meal high in fat, and at the other visit, participants will undergo a stress task.
Detailed description
The investigators will recruit females with a BMI in the normal (18.5-24.9 kg/m2) from the Ball State University campus and surrounding communities. Each participant will complete a meal trial and a stress trial in a randomized crossover design. At the meal trial, an intravenous catheter will be inserted and baseline blood sample collected. Then vascular measurements (i.e., flow-mediated dilation, pulse wave analysis, pulse wave velocity) will be performed. Each time vascular measurements are performed, the participants will lie in a quiet area to acclimate prior to beginning. Next, participants will consume a high-fat, Western style meal consisting of two Jimmy Deans Breakfast Bowls (sausage; 68 g fat; 880 kcal). Following completion of the meal, blood samples will also be collected 1, 2, 3, and 4 hours after the meal. Vascular measurements will be repeated 2 and 4 hours after the meal. Blood will be collected and stored as serum in order to measure triglycerides, HDL-C, and intestinal permeability (e.g., lipopolysaccharide binding protein) using commercially available ELISAs.
At the stress trial, an intravenous catheter will be inserted and baseline blood sample collected. Then vascular measurements (i.e., flow-mediated dilation, pulse wave analysis, pulse wave velocity) will be performed. Each time vascular measurements are performed, the participants will lie in a quiet area to acclimate prior to beginning. Next, participants will undergo the stress task. Then, blood samples will be collected at 10, 60, and 90 minutes after the stress task. Blood will be collected and stored as serum in order to measure epinephrine and inflammatory markers. Vascular measurements will also be repeated 10 and 90 minutes after the stress task.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We are studying human physiology of cardiovascular health in females with a normal BMI. We will not be using any drug interventions. Instead, participants will eat a high-fat meal at one visit and complete a stress task at the other visit. Vascular responses will be assessed.
| Arm | Type | Receives |
|---|---|---|
| High-fat meal trial | Experimental | Other: high-fat mealDuring the "High-fat meal trial", participants will report fasted and consume two Jimmy Dean's breakfast bowls. |
| Stress trial | Experimental | –During the "Stress trial", participants will report fasted and undergo a stress task where they may experience mental stress. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- You are 18-50 years old
- Your biological sex is female
- BMI is in "normal" category (18.5-24.9 kg/m2) - this BMI requirement is due to our research aims
- You are not pregnant or expecting to become pregnant
- You are not postmenopausal
Key exclusion criteria (12 listed)
- You are not 18-50 years old
- Your biological sex is not female
- Your BMI is not in the "normal" category (18.5-24.9 kg/m2) - this BMI requirement is due to our research aims
- You are pregnant or expecting to become pregnant (females only)
- You are postmenopausal
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 |
|---|---|---|
| high-fat mealParticipants will report fasted and consume two Jimmy Dean breakfast bowls (sausage). | Other | High-fat meal trial |
| StressParticipants will report fasted and undergo a mental stress task. | Other | – |
Primary outcome
Flow-mediated dilation
Time frame: Through study completion, up to 1 year.
The investigators will measure FMD at baseline, 2-hours, and 4-hours after meal trial. The investigators will measure FMD at baseline, post-stress task, and 90-minutes after the stress task.
Pulse wave analysis
Time frame: Through study completion, up to 1 year.
The investigators will measure PWA (i.e., augmentation index, augmentation index normalized to a heart rate of 75bpm, aortic/peripheral blood pressure) at baseline, 2-hours, and 4-hours after meal trial using Sphygmacor Xcel System. The investigators will measure PWA at baseline, post-stress task, and 90-minutes after the stress task.
Pulse wave velocity
Time frame: Through study completion, up to 1 year.
The investigators will measure PWV at baseline, 2-hours, and 4-hours after meal trial using the Sphygmacor Xcel System. The investigators will measure PWV at baseline, post-stress task, and 90-minutes after the stress task.
8 secondary outcomes
Serum high-density lipoprotein cholesterol (HDL-C)
Time frame: Through study completion, up to 1 year.
Serum triglycerides
Time frame: Through study completion, up to 1 year.
Serum soluble CD14 (sCD14)
Time frame: Through study completion, up to 1 year.
Serum lipopolysaccharide binding protein (LBP)
Time frame: Through study completion, up to 1 year.
Serum epinephrine
Time frame: Through study completion, up to 1 year.
Serum interleukin-6 (IL-6)
Time frame: Through study completion, up to 1 year.
Heart rate variability (HRV)
Time frame: Through study completion, up to 1 year.
Beat-to-beat systolic and diastolic blood pressure (SBP/DBP)
Time frame: Through study completion, up to 1 year.
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 24 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-fat meal and Stress in people with Normal-weight Obesity and BMI, 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 12 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 24 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 H Keirns, PhD (7652858356, bryant.keirns@bsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-mediated dilation (time frame: Through study completion, up to 1 year.). The study lists 3 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 24 Apr 2026.