Effects of Body Composition on Vascular Health in Females With a Healthy Body Weight
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorBall State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
high-fat meal
Other interventionParticipants will report fasted and consume two Jimmy Dean breakfast bowls (sausage).
Stress
Other interventionParticipants will report fasted and undergo a mental stress task.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: High-fat meal trialExperimental treatment 1 intervention
Group B: Stress trialExperimental treatment 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, up to 1 year.2
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.
Time frame
Through study completion, up to 1 year.3
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.
Time frame
Through study completion, up to 1 year.Secondary outcomes
1
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.
Time frame
Through study completion, up to 1 year.2
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.
Time frame
Through study completion, up to 1 year.3
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.
Time frame
Through study completion, up to 1 year.4
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.
Time frame
Through study completion, up to 1 year.Other outcomes
1
Body composition
The investigators will measure body composition using dual energy x ray absorptiometry (DXA).
Time frame
Through study completion, up to 1 year.2
Systolic and diastolic blood pressure
The investigators will measure blood pressure using an automated cuff (Omron).
Time frame
Through study completion, up to 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov