Hydration Factor Study for the Stayhealthy BC3

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Body Composition

Intervention / Treatment
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* Device: D2O


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Men and women 18-80 years of age Exclusion Criteria: Acute illness (infection, recent surgery, trauma). Pregnancy Pacemaker or defibrillator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: deuterium oxide and BC3<br>Testing of total body water on the BC3 compared to total body water measured by deuterium oxide. | Device: D2O<br>* All participants received deuterium oxide (D2O) and testing with the BC3 for the measurement of total body water.<br>* Other names: Stayhealthy BC3 Body Composition Analyzer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body Fat, Total body water