Clinical trial NCT04504799: Validation of the New HAG-B19 Scale for Measuring Lean and Fat Body Masse
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Composition
Keywords: Body composition
Bioimpendance analysis
Physical activity
Nutrition
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Caucasians/Hispanics adults

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of percent fat mass measurement
timeFrame: 6 months
Secondary outcomes:
measure: Intra- and inter-device variability of percent fat mass measurement
timeFrame: 6 months
measure: Accuracy of percent fat mass measurement compared to gold standard
timeFrame: 6 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
state: Geneva 14
Study officials:
affiliation: University Hospital, Geneva
name: Claude Pichard, Prof
role: STUDY_DIRECTOR
References:
citation: Hamilton-James K, Collet TH, Pichard C, Genton L, Dupertuis YM. Precision and accuracy of bioelectrical impedance analysis devices in supine versus standing position with or without retractable handle in Caucasian subjects. Clin Nutr ESPEN. 2021 Oct;45:267-274. doi: 10.1016/j.clnesp.2021.08.010. Epub 2021 Sep 6.