Recruiting

Observational Study

Sponsor:

University of Roma La Sapienza

Code:

NCT06545435

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Obesity

Study ID

NCT06545435

Start date

May 13, 2021

Status verified date

Aug, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Obese Adults Cohort

This cohort includes Caucasian adult subjects with obesity (BMI ≥ 30 kg/m²). Participants have undergone baseline assessments using both Dual X-ray Absorptiometry (DXA) and Bioelectrical Impedance Analysis (BIA).

MRI Validation Subset

A subset of participants from the Obese Adults Cohort selected for additional validation using Magnetic Resonance Imaging (MRI) to assess muscle size and architecture.

Primary outcome measure

  • Development and Cross-Validation of BIA Equations for Appendicular Soft Tissue Masses [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Lorenzo M Donini, MD

00390649690215lorenzomaria.donini@uniroma1.it

Eleonora Poggiogalle, Md, PhD

00390649690215eleonora.poggiogalle@uniroma1.it

Locations

Pennington Biomedical Research Center, Louisiana State University

Recruiting

Baton Rouge, Louisiana, United States, 70808

Division of Geriatric Medicine, School of Medicine, and Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

University of Alberta, Department of Agricultural, Food and Nutritional Science

Recruiting

Edmonton, Alberta, Canada, T6G 2P5

More Information

Sponsor

University of Roma La Sapienza

Last update posted

Aug 26, 2024

Last verified

Aug, 2024

Keywords

  • Appendicular Lean Mass
  • Fat Mass
  • Body Composition
  • Bio-Impedance Analysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Roma La Sapienza on 2024-08-26.