Body Composition Clinical Trial
— HAG-BIAOfficial 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
Verified date | August 2021 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Geneva University Hospital | Geneva | Geneva 14 |
Lead Sponsor | Collaborator |
---|---|
Prof. Claude Pichard |
Switzerland,
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 |
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