Comparison Study for Bioelectrical Impedance Device to Measure Human Body Composition

Not Applicable

Completed

• Conditions: Body Composition Measurement
• Interventions: Device: Akern USA EFG; Device: RJL Impedance analyzer

• Registration Number: NCT00956917
• Lead Sponsor: Akern USA LLC

Brief Summary

The purpose of this study is to determine if the ElectroFluidGraph(tm) (EFG) impedance analyzer is comparable to a predicate device in measuring human body composition.

Detailed Description

The purpose of this study is to determine if the ElectroFluidGraph(tm) (EFG) impedance analyzer is comparable to a predicate device in measuring human body composition under normal patient conditions. Specifically, the goal of this study is to compare impedance measurements (R and Xc) determined by using each bioelectrical impedance device and the estimated body compositional estimates \[total body water (TBW); fat-free mass (FFM); and fat mass (FM)\] calculated by using the same prediction equation (models) as the predicate device.

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-08
• Study First Submitted: 2009-08-08
• Study First Submitted QC: 2009-08-10
• Last Update Submitted: 2009-08-10
• Study First Posted: 2009-08-11
• Last Update Posted: 2009-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• Healthy individuals

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Akern EFG	Akern USA EFG	-
RJL device	RJL Impedance analyzer	-

Primary Outcome Measures

Name	Time	Method
Resistance (R) - (ohms)	5 minutes

Secondary Outcome Measures

Name	Time	Method
Fat Free Mass (FFM)	5 minutes
Total Body Water (TBW)	5 minutes
Extra Cellular Water	5 minutes
Fat Mass (FM)	5 minutes

Trial Locations

Locations (1)

Laboratorio, FIGC, Settore Tecnico Coverciano; 🇮🇹 D'Annunzio, Florence, Italy