Hydration Factor Study for the Stayhealthy BC3

University of Southern California

Status: Completed

Conditions: Body Composition

Treatments: Device: D2O

Study type: Interventional

Funder types: Other

Identifiers

NCT01209936

Stayhealthy 02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men and women 18-80 years of age

Exclusion criteria

• Acute illness (infection, recent surgery, trauma).
• Pregnancy
• Pacemaker or defibrillator

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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360 participants in 1 patient group

deuterium oxide and BC3

Experimental group

Description:

Testing of total body water on the BC3 compared to total body water measured by deuterium oxide.

Treatment:

Device: D2O