Body CompositionNCT01209936
Hydration Factor Study for the Stayhealthy BC3
A study testing D2O in people with Body Composition, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Composition
- What is being tested?
- D2O
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women 18-80 years of age
Who cannot join
- Acute illness (infection, recent surgery, trauma).
- Pregnancy
- Pacemaker or defibrillator
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Clinical Exercise Research Center
Los Angeles, California, 90033
About this study
Official title: Pilot Study for the Validation of the BC3 Bioelectrical Impedance Hydration Factor
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.
Read the 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.
- Conditions
- Body Composition
- Being tested
- D2O
- Keywords
- Body Fat, Total body water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D2ODevice
Also called Stayhealthy BC3 Body Composition Analyzer
All participants received deuterium oxide (D2O) and testing with the BC3 for the measurement of total body water.
| Study group | Role | What they receive |
|---|---|---|
| deuterium oxide and BC3 | Experimental | Testing of total body water on the BC3 compared to total body water measured by deuterium oxide. Receives: Device: D2O |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Body Fat % for Children Aged 10-17 Years Old
Stayhealthy BC3 was analyzed against hydrostatic weighing for children aged 10-17 years old
Measured: 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
Measured: 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.
Measured: One time point (only one day visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Schroeder, University of Southern California
- Investigators
- Edward T Schroeder, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209936
- Sponsor's protocol ID
- Stayhealthy 02
- Status last verified
- Dec 2023
- First submitted
- 24 Sep 2010
- Last updated
- 11 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Validation of the BC3 Bioelectrical Impedance Hydration Factor
- ClinicalTrials.gov ID
- NCT01209936
- Acronym / sponsor ID
- Stayhealthy 02
- Conditions
- Body Composition
- Keywords
- Body Fat, Total body water
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 27 Sep 2010 (estimated)
- Results
- Posted 11 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| deuterium oxide and BC3 | Experimental | Device: D2OTesting of total body water on the BC3 compared to total body water measured by deuterium oxide. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women 18-80 years of age
Key exclusion criteria (3 listed)
- Acute illness (infection, recent surgery, trauma).
- Pregnancy
- Pacemaker or defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D2OAlso: Stayhealthy BC3 Body Composition AnalyzerAll participants received deuterium oxide (D2O) and testing with the BC3 for the measurement of total body water. | Device | deuterium oxide and BC3 |
Primary outcome
Estimated Body Fat % for Children Aged 10-17 Years Old
Time frame: 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
Time frame: 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
Time frame: One time point (only one day visit)
The body fat percentage as estimated from BC3 and as calculated by a full body DXA.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Body Composition
RecruitingObservational study
Redefining Evaluation of Adiposity and Leanness: Broadening Objective Diagnostics for Obesity
Obesity & Overweight
Active, not recruiting
Effect of Exercise Training on Breastmilk Composition
Obesity
Not yet recruiting
Creatine and Muscle Health in Madrid's Walking Footballers.
Muscle Adaptation, Body Composition
RecruitingPhase 4
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Mild Autonomous Cortisol Secretion (MACS)
RecruitingPhase 2/3
Lean Mass Changes With Semaglutide in Adults With Type 1 Diabetes and Overweight/Obesity.
Type 1 Diabetes, Overweight , Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward T Schroeder, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D2O in people with Body Composition, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Body Fat % for Children Aged 10-17 Years Old (time frame: One time point (only one day visit)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.