Predicting body composition in adults with obesity using bioelectrical impedance analysis.
Predicting Appendicular Lean and Fat Mass With Bioelectrical Impedance Analysis Among Adult Patients With Obesity.
University of Roma La Sapienza · NCT06545435
This study is trying to create better ways to measure body fat and muscle in adults with obesity using a method called bioelectrical impedance analysis to see if it can give more accurate results than current methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Roma La Sapienza (other) |
| Locations | 9 sites (Baton Rouge, Louisiana and 8 other locations) |
| Trial ID | NCT06545435 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and validate new equations for predicting appendicular fat and lean mass in adults with obesity using bioelectrical impedance analysis (BIA). It will compare these new equations with established models and validate them against dual-energy X-ray absorptiometry (DXA) and magnetic resonance imaging (MRI) data. By utilizing existing datasets, the research seeks to improve the accuracy of BIA in assessing body composition, which is crucial for understanding obesity-related health risks and treatment approaches.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a body mass index (BMI) of 30 kg/m² or higher.
Not a fit: Patients with chronic diseases affecting body composition, cognitive impairments, or those who are physically active may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of body composition assessments in obese patients, leading to better-targeted treatments and improved health outcomes.
How similar studies have performed: Previous studies have explored the use of BIA for body composition assessment, but this approach aims to refine and validate new predictive equations, making it a novel contribution to the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults with obesity (BMI ≥ 30 kg/m²) * Age 18 years and older * Available baseline DXA and BIA measurements * Provided informed consent for data use Exclusion Criteria: * any chronic disease or medication that can significantly affect body composition \[eg. malignant diseases in the last 5 years, organ failure, acute inflammation (C-reactive protein\>10 mg/L) autoimmune diseases, neurological diseases, syndromic obesity\] * cognitive impairment (Mini-Mental State Examination \<25) * subjects that are considered physically active (athletes or very active subjects i.e., performing at least 150 minutes of moderate to vigorous physical activity per week) * alcohol intake \>140g/wk for Males and 70g/wk for Females * participation in a weight-reducing program (last 3 months) * impossibility to perform DXA exam * pregnancy and breast-feeding.
Where this trial is running
Baton Rouge, Louisiana and 8 other locations
- Pennington Biomedical Research Center, Louisiana State University — Baton Rouge, Louisiana, United States (RECRUITING)
- Division of Geriatric Medicine, School of Medicine, and Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)
- Curtin University, School of Population Health — Perth, Australia (RECRUITING)
- Federal University of Pelotas — Pelotas, Rio Grande do Sul, Brazil (RECRUITING)
- University of Alberta, Department of Agricultural, Food and Nutritional Science — Edmonton, Alberta, Canada (RECRUITING)
- University of Cagliari, Department of Life and Environmental Sciences — Cagliari, Italy (RECRUITING)
- Sapienza, University of Rome — Roma, Italy (RECRUITING)
- Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy — Trieste, Italy (RECRUITING)
- Universidade de Lisboa, Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana — Lisbon, Portugal (RECRUITING)
Study contacts
- Study coordinator: Lorenzo M Donini, MD
- Email: lorenzomaria.donini@uniroma1.it
- Phone: 00390649690215
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.
Conditions: Obesity, Appendicular Lean Mass, Fat Mass, Body Composition, Bio-Impedance Analysis