NCT02115425

Calibrate Samsung's BIA to Meseaure Body Composition

Samsung Bioimpedance System Calibration Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 421 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: All
• Age: 10 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Body Composition
• Circumference Measurements
• Tissue Thickness Measurements

Interventions

Type	Name	Description
OTHER	Body Measurements	A series of body measurements will be taken by trained staff. These measurements include height and weight. These measurements will be completed twice during this time. You will wear a hospital gown and bathing suit for these measurements.
OTHER	Whole Body DXA Scan	This scan measures the amount of bone, muscle, and fat in your body. The scan will be performed using a whole-body scanner. You will be required to wear a hospital gown, to remove all metal-containing objects from your body, and to lie down on the table.
OTHER	Bioelectrical Impedance Analysis (BIA)	These tests will measure the amount of fat in your body. You will be asked to change into a hospital gown and to remove all footwear and socks/stockings. Once changed and barefoot, you will be asked to stand on a scale (similar to a large gym scale) and to hold on to hand electrodes on each side of the scale. You will be asked to step off of the scale once the measurement is complete (less than one minute). You will also hold on to hand electrodes for three other BIA systems.
OTHER	Bioelectrical Impedance Analysis (BIA)	These tests will measure the amount of fat in your body. You will be asked to change into a hospital gown and to remove all footwear and socks/stockings. You will be asked to hold on to hand electrodes on a hand hold device. You will be asked to complete 3 measurement (less than one minute). You will also hold on to hand electrodes for two other BIA systems.
OTHER	add name here

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-04-16
• Last updated: 2016-09-29

Locations

1 site across 1 country: United States