Validation of the New HAG-B19 Scale for Measuring Lean and Fat Body Masse

Body Composition Clinical Trial

— HAG-BIA  

Official title:

Validation of the New HAG-B19 Scale for Measuring Lean and Fat Body Masses by Comparison With Routinely Used Bioelectrical Impedance Analysis and Dual X-Ray Absorptiometry in Western Healthy Adults: The Geneva HAG-BIA Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04504799
• Other study ID #: 2020-01613
• Status: Completed
• Start date: September 3, 2020
• Est. completion date: February 25, 2021

Study information

• Verified date: August 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Body composition measurement is an important tool for assessing the physical condition of sick or healthy people, as well as for monitoring changes in body composition and physical performance during diet and/or training. Many people self-monitor their body composition using portable and inexpensive assessment tools, but most of them have not been tested for accuracy and precision.

This study aims to assess the accuracy and precision of a new portable impedancemeter scale to measure body composition in comparison with proven techniques, such as 4-electrode electrical bioimpedance analysis and dual X-ray absorptiometry.

Description:

This is an observational, prospective, cross-sectional study to evaluate the accuracy and precision of the new HAG-B19 in healthy Western adults. A stratified sampling method is used to recruit a heterogeneous sample of 160 subjects, covering a wide range of ages and body compositions according to gender specific BMI distributions in the population. Volunteers who signed the informed consent form are included in the study. A financial compensation of 50.- CHF is given to each participant (100.- to the 16 participants subjected to the DEXA measurements).

The body composition of each subject (FM, LBM and FM%) is assessed with sequential measurements using 3 HAG-B19 and 3 Nutriguard-M® devices (Data Input, Germany). FM% values measured by HAG-B19 are compared to values by Nutriguard-M® to assess the accuracy and precision of HAG-B19 (main objective). Intra- and inter-device variability are obtained by comparing the 3 repeated measurements and the 3 HAG-B19 devices (secondary objective). In a subgroup of 16 individuals, the FM% values measured by HAG-B19 are compared to DEXA measurements (secondary objective). Pearson correlations and Bland-Altman graphs are performed to assess the agreement of the measurements between the devices and paired t-tests are used to determine if there is a bias between the devices. The significance of the statistical analysis is fixed at p <0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 25, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

Healthy Caucasians/Hispanics adults who signed the informed consent form (healthy defined as no chronic disease, no hospitalisation for the last 6 months, no physical disability)

Exclusion Criteria:

• BMI <18.5 or = 30 kg/m2

• No informed consent form signed

• Inability to understand the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.

• Medication impacting fluid and electrolyte balance (diuretics or calcium channel blocker)

• Moderate to intense level physical activity 2-3 h before measurement

• Pregnancy

Related Conditions & MeSH terms

• Body Composition

Intervention

Device:
• Body composition measurement with HAG-BIA scale
Bio-impendance analysis

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Geneva	Geneva 14

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Claude Pichard

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of percent fat mass measurement	Comparison between HAG-B19 and Nutriguard-M measurement	6 months
Secondary	Intra- and inter-device variability of percent fat mass measurement	Comparison of measurements within and between three HAG-B19 devices.	6 months
Secondary	Accuracy of percent fat mass measurement compared to gold standard	Comparison between HAG-B19 and DEXA in 10 percents of participants	6 months