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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01209936
Other study ID # Stayhealthy 02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2009
Est. completion date July 2010

Study information

Verified date December 2023
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This was a pilot study to validate the BC3 hydration factor which will be important for determining how well this value represents hydration status compared to assessment of total body water by D20.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 360
Est. completion date July 2010
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: • Men and women 18-80 years of age Exclusion Criteria: - Acute illness (infection, recent surgery, trauma). - Pregnancy - Pacemaker or defibrillator

Study Design


Related Conditions & MeSH terms


Intervention

Device:
D2O
All participants received deuterium oxide (D2O) and testing with the BC3 for the measurement of total body water.

Locations

Country Name City State
United States USC Clinical Exercise Research Center Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Estimated Body Fat % for Children Aged 10-17 Years Old Stayhealthy BC3 was analyzed against hydrostatic weighing for children aged 10-17 years old One time point (only one day visit)
Primary Percent Body Fat in Women Aged 18-80 Years Old Body fat percentage was measured via Stayhealthy BC3 as well as a full body DXA One time point (only one day visit)
Primary Estimated Percent Body Fat for Men Aged 18-80 The body fat percentage as estimated from BC3 and as calculated by a full body DXA. One time point (only one day visit)
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