Hydration Factor Study for the Stayhealthy BC3
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Pilot Study for the Validation of the BC3 Bioelectrical Impedance Hydration Factor|
- Total body water [ Time Frame: 6 months ] [ Designated as safety issue: No ]Total body water will be estimated by the BC3 bioelectrical impedance device and compared to total body water measured by deuterium oxide studies.
|Study Start Date:||September 2009|
|Study Completion Date:||July 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Experimental: deuterium oxide and BC3
Testing of total body water on the BC3 compared to total body water measured by deuterium oxide.
All participants received deuterium oxide (D2O) and testing with the BC3 for the measurement of total body water.
Other Name: Stayhealthy BC3 Body Composition Analyzer
The BC3 body composition analyzer is manufactured by Stayhealthy. It is a handheld, noninvasive bioelectrical impedance device. When held, the BC3 sends an electrical impulse through the body to determine body fat, lean mass, and total body hydration. Bio-impedance devices measure the change in electrical resistance in body tissues by using a detectable electrical signal that passes through the body. The method is based on the principle that lean body mass contains virtually all the water and conducting electrolytes in the body and provides a good electrical pathway. In contrast, fat or fat-containing tissues produce a poor electrical pathway. By inducing a low-energy, high-frequency signal, a measurement of the baseline resistance to flow of electrical current can be assessed. The resistance measurement relates directly to the volume of the conductor. Through repeated measurements and identifying other parameters (i.e. gender, weight, age and height) proprietary equations were developed that determine total body water, lean mass, and % body fat.
The purpose of this study is to validate the calculated hydration factor produced by the BC3 bioelectrical impedance device. If this value is valid and comparable to the gold standard (D20) then this hydration factor will offer a very quick and inexpensive method to determine total body hydration status using a hand-held bioelectrical impedance device.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01209936
|United States, California|
|USC Clinical Exercise Research Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Edward T Schroeder, PhD||University of Southern California|