Impact of body composition on vascular health in healthy-weight females
Resting Indicators of Vascular Health and Cardiovascular Reactivity in Females With "Normal-Weight Obesity"
This study is testing how the balance of fat and muscle in healthy-weight women affects their blood vessel health after eating a high-fat meal or experiencing stress.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Ball State University Academic / other |
| Locations | 1 site (Muncie, Indiana) |
| Trial ID | NCT06818500 on ClinicalTrials.gov |
What this trial studies
This study investigates how body composition, specifically the ratio of body fat to muscle mass, affects vascular health in females with a healthy body weight. Participants will undergo two different trials: one involving a high-fat meal and the other involving a stress task. During each trial, vascular measurements and blood samples will be collected to assess cardiovascular risk factors. The study aims to provide insights into the relationship between body composition and vascular health, which is not fully captured by BMI alone.
Who should consider this trial
Good fit: Ideal candidates are females aged 18-50 with a BMI in the normal range and no history of cardiometabolic or chronic inflammatory conditions.
Not a fit: Patients who are pregnant, postmenopausal, or have been diagnosed with cardiometabolic or chronic inflammatory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of cardiovascular risks in women with normal BMI, potentially guiding better health recommendations.
How similar studies have performed: While there is ongoing research into body composition and vascular health, this specific approach focusing on normal-weight obesity in females is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Muncie, Indiana
- Ball State University- Nutrition Assessment Lab — Muncie, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Bryant H Keirns, PhD
- Email: bryant.keirns@bsu.edu
- Phone: 7652858356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.