NCT04504799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

September 3, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2021

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

August 5, 2020

Last Update Submit

August 5, 2021

Conditions

Keywords

Body compositionBioimpendance analysisPhysical activityNutrition

Outcome Measures

Primary Outcomes (1)

  • Accuracy of percent fat mass measurement

    Comparison between HAG-B19 and Nutriguard-M measurement

    6 months

Secondary Outcomes (2)

  • Intra- and inter-device variability of percent fat mass measurement

    6 months

  • Accuracy of percent fat mass measurement compared to gold standard

    6 months

Interventions

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy Caucasians/Hispanics adults

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospital

Geneva, Geneva 14, 1211, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Claude Pichard, Prof

    University Hospital, Geneva

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head, Clinical Nutrition

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 7, 2020

Study Start

September 3, 2020

Primary Completion

February 25, 2021

Study Completion

February 25, 2021

Last Updated

August 12, 2021

Record last verified: 2021-08

Locations