Body Composition
Conditions
Keywords
Body Fat, Total body water
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.
Interventions
DEVICED2O
All participants received deuterium oxide (D2O) and testing with the BC3 for the measurement of total body water.
Sponsors
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
• Men and women 18-80 years of age
Exclusion criteria
* Acute illness (infection, recent surgery, trauma). * Pregnancy * Pacemaker or defibrillator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Body Fat % for Children Aged 10-17 Years Old | One time point (only one day visit) | Stayhealthy BC3 was analyzed against hydrostatic weighing for children aged 10-17 years old |
| Percent Body Fat in Women Aged 18-80 Years Old | One time point (only one day visit) | Body fat percentage was measured via Stayhealthy BC3 as well as a full body DXA |
| Estimated Percent Body Fat for Men Aged 18-80 | One time point (only one day visit) | The body fat percentage as estimated from BC3 and as calculated by a full body DXA. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 245 |
| 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 | 115 |
| Total | 360 |
Baseline characteristics
| Characteristic | Children | Total | Adults |
|---|---|---|---|
| Age, Continuous | 14.9 Years STANDARD_DEVIATION 1.7 | 30.15 Years STANDARD_DEVIATION 9.225 | 45.4 Years STANDARD_DEVIATION 16.75 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 115 participants | 360 participants | 245 participants |
| Sex: Female, Male Female | 64 Participants | 192 Participants | 128 Participants |
| Sex: Female, Male Male | 51 Participants | 168 Participants | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 245 | 0 / 117 |
| serious Total, serious adverse events | 0 / 245 | 0 / 117 |
Outcome results
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
Time frame: One time point (only one day visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Estimated Body Fat % From BC3 for Children Aged 10-17 Years Old | Estimated Body Fat % for Children Aged 10-17 Years Old | BC3 | 18.4 Percent body fat | Standard Deviation 8.4 |
| Estimated Body Fat % From BC3 for Children Aged 10-17 Years Old | Estimated Body Fat % for Children Aged 10-17 Years Old | Hydrostatic Weighing | 18.8 Percent body fat | Standard Deviation 8.3 |
p-value: 0.87t-test, 2 sided
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.
Time frame: One time point (only one day visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Estimated Body Fat % From BC3 for Children Aged 10-17 Years Old | Estimated Percent Body Fat for Men Aged 18-80 | BC3 | 20.3 Percent body fat | Standard Deviation 5.3 |
| Estimated Body Fat % From BC3 for Children Aged 10-17 Years Old | Estimated Percent Body Fat for Men Aged 18-80 | DXA | 20.4 Percent body fat | Standard Deviation 5.6 |
p-value: 0.55t-test, 2 sided
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
Time frame: One time point (only one day visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Estimated Body Fat % From BC3 for Children Aged 10-17 Years Old | Percent Body Fat in Women Aged 18-80 Years Old | BC3 | 32.8 Percent body fat | Standard Deviation 9.1 |
| Estimated Body Fat % From BC3 for Children Aged 10-17 Years Old | Percent Body Fat in Women Aged 18-80 Years Old | DXA | 33.4 Percent body fat | Standard Deviation 9.6 |
p-value: 0.17t-test, 2 sided