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

NCT06818500 | Recruiting

• 1 other identifier: 2201237-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Normal-weight Obesity; BMI; Stress

Keywords

BMI; Stress; Healthy BMI

Outcome Measures

Primary Outcomes (3)

• 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.

  Through study completion, up to 1 year.

• 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.

  Through study completion, up to 1 year.

• 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.

  Through study completion, up to 1 year.

Secondary Outcomes (8)

• Serum high-density lipoprotein cholesterol (HDL-C)

  Through study completion, up to 1 year.

• Serum triglycerides

  Through study completion, up to 1 year.

• Serum soluble CD14 (sCD14)

  Through study completion, up to 1 year.

• Serum lipopolysaccharide binding protein (LBP)

  Through study completion, up to 1 year.

• Serum epinephrine

  Through study completion, up to 1 year.

Other Outcomes (2)

• Body composition

  Through study completion, up to 1 year.

• Systolic and diastolic blood pressure

  Through study completion, up to 1 year.

Study Arms (2)

High-fat meal trial

EXPERIMENTAL

During the "High-fat meal trial", participants will report fasted and consume two Jimmy Dean's breakfast bowls.

Other: high-fat meal

Stress trial

EXPERIMENTAL

During the "Stress trial", participants will report fasted and undergo a stress task where they may experience mental stress.

Interventions

high-fat meal OTHER

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

High-fat meal trial

Stress OTHER

Participants will report fasted and undergo a mental stress task.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ball State University: lead

Study Sites (1)

Ball State University- Nutrition Assessment Lab

Muncie, Indiana, 47303, United States

RECRUITING

Central Study Contacts

Bryant H Keirns, PhD

CONTACT

7652858356; bryant.keirns@bsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We are studying human physiology of cardiovascular health in females with a normal BMI. We will not be using any drug interventions. Instead, participants will eat a high-fat meal at one visit and complete a stress task at the other visit. Vascular responses will be assessed.

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 10, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)