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临床试验/NCT04504799
NCT04504799已完成不适用

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

Prof. Claude Pichard1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年9月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
试验地点
1
主要终点
Accuracy of percent fat mass measurement

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Accuracy of percent fat mass measurement

时间窗: 6 months

Comparison between HAG-B19 and Nutriguard-M measurement

次要结局

  • Accuracy of percent fat mass measurement compared to gold standard(6 months)
  • Intra- and inter-device variability of percent fat mass measurement(6 months)

研究者

发起方
Prof. Claude Pichard
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Claude Pichard

Head, Clinical Nutrition

University Hospital, Geneva

研究点 (1)

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