Clinical trial

Effects of Body Composition on Vascular Health in Females With a Healthy Body Weight

Recruiting now · Not applicable · 1 countries · Registry ID NCT06818500

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 50 Years
SexFemale
Healthy volunteersAccepted
ConditionNormal-weight Obesity, BMI, Stress

Full registry 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

Treatments and study arms

high-fat meal

Other

Participants will report fasted and consume two Jimmy Dean breakfast bowls (sausage).

Stress

Other

Participants will report fasted and undergo a mental stress task.

Primary outcomes

Flow-mediated dilationThrough 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 analysisThrough 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 velocityThrough 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Ball State University- Nutrition Assessment Lab🇺🇸 Muncie, Indiana, United States
Bryant H Keirns, PhDContact
Bryant H Keirns, PhDPrincipal Investigator