Development of a Segmental Bioelectrical Impedance Spectroscopy Device for Body Composition Measurement

A device for measuring body composition with a small electric current, at 200 μA, (bioelectrical impedance analysis, or BIA) was designed. The goal of this study is to validate the device against several existing devices using the same method of measuring body composition with a small electric current.

Study Overview

• Status: Completed
• Conditions: Medical Device
• Intervention / Treatment: Device: Bioelectrical Impedance Monitor

Detailed Description

The measurement of individual segments, instead of the body as a whole, with BIA has not been fully explored. The prototype device is capable of directly measuring multiple body segments (arm, trunk, and leg) simultaneously, and the final version will be able to provide composition about each segment and the body as a whole. Current devices on the market are not capable of this.

The reference devices will be used to measure segments as well, and the raw measurements will be compared. The Multiscan 5000 provides segmental body composition for the arm or leg, but requires measuring it separately. The SFB7 is designed only for measuring the whole body, but the raw impedance measurement data from the SFB7 can be used for comparison, as the impedance magnitudes of individual segments will be within its measurement range. The Seca 514 doesn't directly measure segments, but it can provide segmental data by measuring from hand to foot, then from hand to hand, and finally from foot to foot. It then uses these measurements, and assumptions about the subject to provide segmental composition data.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Statesboro, Georgia, United States, 30459
      • Georgia Southern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Students from Georgia Southern University

Description

Inclusion Criteria:

• Students from Georgia Southern University

Exclusion Criteria:

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
subj 1; Three commercially available BIA devices vs SBIS device	Device: Bioelectrical Impedance Monitor; Subjects had been under the test of three commercially available devices and the device that the investigators had developed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impedance values from each devices	Bioelectrical impedance values from three devices were measured and recorded.	One year IRB period

Collaborators and Investigators

• Sponsor: Jun Choi
• Investigators: Principal Investigator: junghun choi, Ph.D., Georgia Southern University

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2018
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Bioelectrical Impedance spectroscopy; Body compositions; Segmental Bioelectrical impedance spectroscopy
• Other Study ID Numbers: GSU001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No