Effects of Body Composition on Vascular Health in Females With a Healthy Body Weight
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: high-fat meal, Stress.
- Who it may be relevant to
- Registry conditions: Normal-weight Obesity, BMI, Stress. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Resting Indicators of Vascular Health and Cardiovascular Reactivity in Females With "Normal-Weight Obesity"
Overview
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.
Interventions
- Other high-fat meal
Participants will report fasted and consume two Jimmy Dean breakfast bowls (sausage). - Other Stress
Participants will report fasted and undergo a mental stress task.
Primary outcome measures
- Flow-mediated dilation [Time frame: Through study completion, up to 1 year.]
- Pulse wave analysis [Time frame: Through study completion, up to 1 year.]
- Pulse wave velocity [Time frame: Through study completion, up to 1 year.]
Secondary outcome measures (8)
- 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.]
Eligibility criteria
Inclusion criteria
- 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)
- 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
Exclusion criteria
- 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)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Ball State University- Nutrition Assessment Lab — Muncie
Identifiers
NCT: NCT06818500 · 2201237-1