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CompletedNCT01209936

Hydration Factor Study for the Stayhealthy BC3

Pilot Study for the Validation of the BC3 Bioelectrical Impedance Hydration Factor

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
360 (actual)
Sponsor
University of Southern California · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DEVICED2OAll participants received deuterium oxide (D2O) and testing with the BC3 for the measurement of total body water.

Timeline

Start date
2009-09-01
Primary completion
2010-06-01
Completion
2010-07-01
First posted
2010-09-27
Last updated
2023-12-11
Results posted
2023-12-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01209936. Inclusion in this directory is not an endorsement.

Hydration Factor Study for the Stayhealthy BC3 (NCT01209936) · Clinical Trials Directory