Recruiting

Observational Study

Sponsor:

Ball State University

Code:

NCT06818500

Conditions

Normal-weight Obesity

BMI

Stress

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

high-fat meal

Stress

Study Details

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

Study ID

NCT06818500

Start date

Sep 1, 2024

Status verified date

Apr, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: High-fat meal trial

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

experimental: Stress trial

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

Interventions

high-fat meal

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

Stress

Participants will report fasted and undergo a mental stress task.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Bryant H Keirns, PhD

7652858356bryant.keirns@bsu.edu

Locations

Ball State University- Nutrition Assessment Lab

Recruiting

Muncie, Indiana, United States, 47303

Contacts

Bryant H Keirns, PhD

7652858356bryant.keirns@bsu.edu

Principal Investigator:

Bryant H Keirns, PhD

More Information

Sponsor

Ball State University

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • BMI
  • Stress
  • Healthy BMI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ball State University on 2026-04-24.