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Hydration Factor Study for the Stayhealthy BC3

Not Applicable
Completed
Conditions
Body Composition
Interventions
Device: D2O
Registration Number
NCT01209936
Lead Sponsor
University of Southern California
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
360
Inclusion Criteria

• Men and women 18-80 years of age

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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
deuterium oxide and BC3D2OTesting of total body water on the BC3 compared to total body water measured by deuterium oxide.
Primary Outcome Measures
NameTimeMethod
Estimated Percent Body Fat for Men Aged 18-80One time point (only one day visit)

The body fat percentage as estimated from BC3 and as calculated by a full body DXA.

Percent Body Fat in Women Aged 18-80 Years OldOne time point (only one day visit)

Body fat percentage was measured via Stayhealthy BC3 as well as a full body DXA

Estimated Body Fat % for Children Aged 10-17 Years OldOne time point (only one day visit)

Stayhealthy BC3 was analyzed against hydrostatic weighing for children aged 10-17 years old

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

USC Clinical Exercise Research Center

🇺🇸

Los Angeles, California, United States

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