Trial Outcomes & Findings for Hydration Factor Study for the Stayhealthy BC3 (NCT NCT01209936)
NCT ID: NCT01209936
Last Updated: 2023-12-11
Results Overview
Stayhealthy BC3 was analyzed against hydrostatic weighing for children aged 10-17 years old
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
360 participants
Primary outcome timeframe
One time point (only one day visit)
Results posted on
2023-12-11
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
245
|
115
|
|
Overall Study
COMPLETED
|
245
|
115
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Adults
n=245 Participants
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.
|
Children
n=115 Participants
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
|
Total
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.4 Years
STANDARD_DEVIATION 16.75 • n=245 Participants
|
14.9 Years
STANDARD_DEVIATION 1.7 • n=115 Participants
|
30.15 Years
STANDARD_DEVIATION 9.225 • n=360 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=245 Participants
|
64 Participants
n=115 Participants
|
192 Participants
n=360 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=245 Participants
|
51 Participants
n=115 Participants
|
168 Participants
n=360 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
245 participants
n=245 Participants
|
115 participants
n=115 Participants
|
360 participants
n=360 Participants
|
PRIMARY outcome
Timeframe: One time point (only one day visit)Stayhealthy BC3 was analyzed against hydrostatic weighing for children aged 10-17 years old
Outcome measures
| Measure |
Estimated Body Fat % From BC3 for Children Aged 10-17 Years Old
n=115 Participants
The body fat percentage as measured by the Stayhealthy body composition analyzer BC3
|
|---|---|
|
Estimated Body Fat % for Children Aged 10-17 Years Old
BC3
|
18.4 Percent body fat
Standard Deviation 8.4
|
|
Estimated Body Fat % for Children Aged 10-17 Years Old
Hydrostatic Weighing
|
18.8 Percent body fat
Standard Deviation 8.3
|
PRIMARY outcome
Timeframe: One time point (only one day visit)Body fat percentage was measured via Stayhealthy BC3 as well as a full body DXA
Outcome measures
| Measure |
Estimated Body Fat % From BC3 for Children Aged 10-17 Years Old
n=128 Participants
The body fat percentage as measured by the Stayhealthy body composition analyzer BC3
|
|---|---|
|
Percent Body Fat in Women Aged 18-80 Years Old
BC3
|
32.8 Percent body fat
Standard Deviation 9.1
|
|
Percent Body Fat in Women Aged 18-80 Years Old
DXA
|
33.4 Percent body fat
Standard Deviation 9.6
|
PRIMARY outcome
Timeframe: One time point (only one day visit)The body fat percentage as estimated from BC3 and as calculated by a full body DXA.
Outcome measures
| Measure |
Estimated Body Fat % From BC3 for Children Aged 10-17 Years Old
n=117 Participants
The body fat percentage as measured by the Stayhealthy body composition analyzer BC3
|
|---|---|
|
Estimated Percent Body Fat for Men Aged 18-80
BC3
|
20.3 Percent body fat
Standard Deviation 5.3
|
|
Estimated Percent Body Fat for Men Aged 18-80
DXA
|
20.4 Percent body fat
Standard Deviation 5.6
|
Adverse Events
Deuterium Oxide and BC3 Adult
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Deuterium Oxide and BC3 Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place