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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stress; BMI; Normal-weight Obesity
• Intervention / Treatment: Other: high-fat meal; Other: Stress

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bryant H Keirns, PhD; Phone Number: 7652858356; Email: bryant.keirns@bsu.edu

Study Locations

• United States
  • Indiana
    • Muncie, Indiana, United States, 47303
      • Recruiting
      • Ball State University- Nutrition Assessment Lab
      • Contact: Bryant H Keirns, PhD; Phone Number: 7652858356; Email: bryant.keirns@bsu.edu
      • Principal Investigator: Bryant H Keirns, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-fat meal trial; During the "High-fat meal trial", participants will report fasted and consume two Jimmy Dean's breakfast bowls.	Other: high-fat meal; Participants will report fasted and consume two Jimmy Dean breakfast bowls (sausage).
Experimental: Stress trial; During the "Stress trial", participants will report fasted and undergo a stress task where they may experience mental stress.	Other: Stress; Participants will report fasted and undergo a mental stress task.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion, up to 1 year.
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.	Through study completion, up to 1 year.
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.	Through study completion, up to 1 year.
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.	Through study completion, up to 1 year.
Serum epinephrine	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.	Through study completion, up to 1 year.
Serum interleukin-6 (IL-6)	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.	Through study completion, up to 1 year.
Heart rate variability (HRV)	The investigator will analyze HRV pre-, during, and post-stress task during the stress trial (Task Force Monitor).	Through study completion, up to 1 year.
Beat-to-beat systolic and diastolic blood pressure (SBP/DBP)	The investigator will analyze SBP/DBP pre, during, and post-stress task during the stress trial (Task Force Monitor).	Through study completion, up to 1 year.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	The investigators will measure body composition using dual energy x ray absorptiometry (DXA).	Through study completion, up to 1 year.
Systolic and diastolic blood pressure	The investigators will measure blood pressure using an automated cuff (Omron).	Through study completion, up to 1 year.

Collaborators and Investigators

• Sponsor: Ball State University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Stress; BMI; Healthy BMI
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Overweight; Obesity; Body Weight
• Other Study ID Numbers: 2201237-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No