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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| deuterium oxide and BC3 | Experimental | Testing of total body water on the BC3 compared to total body water measured by deuterium oxide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D2O | Device | All participants received deuterium oxide (D2O) and testing with the BC3 for the measurement of total body water. |
|
| 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) |
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Inclusion Criteria:
• Men and women 18-80 years of age
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward T Schroeder, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Clinical Exercise Research Center | Los Angeles | California | 90033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adults | All adults underwent a 10-15 minute total body DXA Scan. All adults used the Stayhealthy body composition analyzer BC3 for BIA to measure body composition. All participants received deuterium oxide (D2O) and testing with the BC3 for the measurement of total body water. |
| FG001 | Children | All children were measured using Hydrostatic Weighing (HW) to assess body composition, a DEXA was not used to avoid unnecessary radiation exposure. HW was measured by placing the participants in a chair suspended from spring-loaded scale inside a plexiglass tank. Weight was averaged among 3 trials, that fell within 100g of each other. Density was adjusted for residual volume using an estimated volume of 115 mL. % body fat was calculated using Lohman's equations to adjust for age and sex. All children used the Stayhealthy body composition analyzer BC3 for BIA to measure body composition. All participants received deuterium oxide (D2O) and testing with the BC3 for the measurement of total body water. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adults | All adults underwent a 10-15 minute total body DXA Scan. All adults used the Stayhealthy body composition analyzer BC3 for BIA to measure body composition. All participants received deuterium oxide (D2O) and testing with the BC3 for the measurement of total body water. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | Percent body fat | One time point (only one day visit) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deuterium Oxide and BC3 Adult | Testing of total body water on the BC3 compared to total body water measured by deuterium oxide. D2O: All participants received deuterium oxide (D2O) and testing with the BC3 for the measurement of total body water. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Erceg | University of Southern California | (323) 442-2900 | erceg@usc.edu |
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| Children |
All children were measured using Hydrostatic Weighing to assess body composition. All children used the Stayhealthy body composition analyzer BC3 for BIA to measure body composition. All participants received deuterium oxide (D2O) and testing with the BC3 for the |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Percent body fat | 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. | Posted | Mean | Standard Deviation | Percent body fat | One time point (only one day visit) |
|
|
|
|
| 0 |
| 245 |
| 0 |
| 245 |
| EG001 | Deuterium Oxide and BC3 Children | Testing of total body water on the BC3 compared to total body water measured by deuterium oxide. D2O: All participants received deuterium oxide (D2O) and testing with the BC3 for the measurement of total body water. | 0 | 117 | 0 | 117 |
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