Calibrate Samsung's BIA to Meseaure Body Composition — Samsung  

Body Composition Clinical Trial

Official title: Samsung Bioimpedance System Calibration Study

Status Completed

Clinical Trial Summary

The purpose of this study is to collect body composition data using bioimpedance analysis (Samsung) and DXA (GE Medical). Both of the methods are explained in more detail in section 5 of this consent. The data collected will help Samsung improve the products the company offers.

Clinical Trial Description

If you are eligible and you choose to participate in this study, you will be asked to come to the Bone & Joint Clinic of Baton Rouge in Baton Rouge between 7:00 and 11:00 am after at least a two-hour fast (nothing to eat or drink besides water for 2 hours prior to your appointment). You will be asked not to exercise, shower, or use a steam room or sauna at least two hours prior to evaluation. The study visit will take approximately one hour. During the visit, you will complete the informed consent process and then complete the baseline body measurements and body composition procedures immediately afterwards. Adult pre-menopausal women will have a urine pregnancy test prior to evaluation. Study procedures are not for diagnostic or treatment purposes and the DXA scan is intended for research purposes.

Description of study procedures

Body Measurements (about 15 minutes):

A series of body measurements will be taken by trained staff. These measurements include height, weight, and vital signs. The weight and height measurements will be completed twice during this time. The subject will wear a hospital gown and tight fitting garments for these procedures and the subject's BMI will be calculated from these measurements.

Body Composition Measurements

Whole Body DXA Scan, about 20 minutes This scan measures the amount of bone, muscle, and fat in your body. The scan will be performed using a whole-body scanner. The subject will be required to wear a hospital gown, to remove all metal-containing objects from the body, and to lie down on the table. The subject will be carefully positioned on the table, and the legs will be placed together using two Velcro straps. A scanner emitting low energy X-rays and a detector will pass along the body. The subject will be asked to remain completely still while the scan is in progress. The scan takes approximately ten minutes.

Impedance Analysis (BIA) (about 10 minutes):

These tests will measure the amount of fat in the body. These procedures will vary depending on the measurement system and several different BIA systems will be used during this test.

Some examples are presented in the supplementary material at the end of this protocol.

Specifically, the following systems will be used in this study:

Samsung Health Cover; Measure 3 times; Standing Posture

Marketed systems:

InBody720 (http://www.biospaceamerica.com/Product/ib720.html; measure one time; Standing Posture Omron 306; Measure 1 time; Standing Posture Omron 510; Measure 1 time; Standing Posture ;

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Body Composition
• Circumference Measurements
• Tissue Thickness Measurements

• NCT number: NCT02115425
• Study type: Observational
• Source: Pennington Biomedical Research Center
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Completion date: December 2015