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NCT Number: NCT06818500

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ball State University- Nutrition Assessment Lab

Muncie, Indiana, 47303, United States

Location status: Recruiting

Location contact

Bryant H Keirns, PhD

CONTACT

[email protected]

7652858356

Bryant H Keirns, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Serum high-density lipoprotein cholesterol (HDL-C)

    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.

  2. Serum triglycerides

    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.

  3. Serum soluble CD14 (sCD14)

    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.

  4. Serum lipopolysaccharide binding protein (LBP)

    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.

  5. Serum epinephrine

    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.

  6. Serum interleukin-6 (IL-6)

    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.

  7. Heart rate variability (HRV)

    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).

  8. Beat-to-beat systolic and diastolic blood pressure (SBP/DBP)

    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).

Other outcomes

  1. Body composition

    Time frame: Through study completion, up to 1 year.

    The investigators will measure body composition using dual energy x ray absorptiometry (DXA).

  2. Systolic and diastolic blood pressure

    Time frame: Through study completion, up to 1 year.

    The investigators will measure blood pressure using an automated cuff (Omron).

Study contacts

Contact information is provided by the study sponsor or research team.

Bryant H Keirns, PhD

CONTACT

[email protected]

7652858356

Sponsors and collaborators

Lead sponsor

Ball State University

Other

Registry information

Official study title

Resting Indicators of Vascular Health and Cardiovascular Reactivity in Females With "Normal-Weight Obesity"

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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