Ball State University- Nutrition Assessment Lab
Muncie, Indiana, 47303, United States
Location status: Recruiting
Location contact
Bryant H Keirns, PhD
CONTACT
Bryant H Keirns, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06818500
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.
Interested in participating?
Request Info18 year–50 year
Female
Interventional
Not applicable
Muncie, Indiana, 47303, United States
Location status: Recruiting
Bryant H Keirns, PhD
CONTACT
Bryant H Keirns, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will report fasted and consume two Jimmy Dean breakfast bowls (sausage).
Participants will report fasted and undergo a mental stress task.
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.
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.
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.
Time frame: Through study completion, up to 1 year.
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.
Time frame: Through study completion, up to 1 year.
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.
Time frame: Through study completion, up to 1 year.
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.
Time frame: Through study completion, up to 1 year.
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.
Time frame: Through study completion, up to 1 year.
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.
Time frame: Through study completion, up to 1 year.
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.
Time frame: Through study completion, up to 1 year.
The investigator will analyze HRV pre-, during, and post-stress task during the stress trial (Task Force Monitor).
Time frame: Through study completion, up to 1 year.
The investigator will analyze SBP/DBP pre, during, and post-stress task during the stress trial (Task Force Monitor).
Time frame: Through study completion, up to 1 year.
The investigators will measure body composition using dual energy x ray absorptiometry (DXA).
Time frame: Through study completion, up to 1 year.
The investigators will measure blood pressure using an automated cuff (Omron).
Contact information is provided by the study sponsor or research team.
Ball State University
Other
Resting Indicators of Vascular Health and Cardiovascular Reactivity in Females With "Normal-Weight Obesity"
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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