Predicting Appendicular Lean and Fat Mass With Bioelectrical Impedance Analysis Among Adult Patients With Obesity.

Recruiting now

Conditions studied: Obesity

In brief

This study aims to develop and cross-validate novel bioelectrical impedance analysis (BIA) equations for predicting appendicular soft tissue masses, specifically fat mass (FM) and appendicular lean mass (ALM), in a sample of Caucasian adult subjects affected by obesity. The research will compare these new BIA equations with three established BIA-derived prediction models and validate them using dual-energy X-ray absorptiometry (DXA) and magnetic resonance imaging (MRI) data. This study utilizes existing datasets to enhance the accuracy and applicability of BIA in assessing body composition and supports the development of standardized algorithms for converting raw BIA data across different devices and populations.

Key facts

Study ID

NCT06545435

Run by

University of Roma La Sapienza

People needed

400

Starts

2021-05-13

Expected to finish

2025-12-31

Last updated by the study team

2024-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults with obesity (BMI ≥ 30 kg/m²)
• Age 18 years and older
• Available baseline DXA and BIA measurements
• Provided informed consent for data use

You may not qualify if…

• 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 it is running

• Pennington Biomedical Research Center, Louisiana State University — Baton Rouge, Louisiana, United States (enrolling)
• 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 (enrolling)
• Curtin University, School of Population Health — Perth, Australia (enrolling)
• Federal University of Pelotas — Pelotas, Rio Grande do Sul, Brazil (enrolling)
• University of Alberta, Department of Agricultural, Food and Nutritional Science — Edmonton, Alberta, Canada (enrolling)
• University of Cagliari, Department of Life and Environmental Sciences — Cagliari, Italy (enrolling)
• Sapienza, University of Rome — Roma, Italy (enrolling)
• Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy — Trieste, Italy (enrolling)
• Universidade de Lisboa, Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana — Lisbon, Portugal (enrolling)

Full record on ClinicalTrials.gov

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