Total Body Water AssessmentNCT01607229
Multi-frequency Bioelectrical Impedance for Estimating Total Body Water by Deuterium Dilution
An observational study of Total Body Water Assessment, run by University of Southern California at 1 site in United States.
Trial summary
SPECIFIC AIM: Determine the validity of the Biospace bioelectrical impedance devices compared to deuterium water (D2O) measurements. HYPOTHESIS: The Biospace Body Composition Analyzers are valid tools for measuring total body water and body composition. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Body Water Assessment
- What is being tested?
- observation
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: community sample
Who may be able to join
- men and women between 18-59 years of age
Who cannot join
- Acute illness (infection, recent surgery, trauma).
- pregnancy
- pacemaker or defibrillator
- We would like to standardize the procedures and measurements in the adult population first. Older adults are excluded because by including older adults at this time, we would need to increase the sample size because we believe older adults have greater fluctuations in hydration due to medications, diet, and co-morbidities.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: Utility of Multi-frequency Bioelectrical Impedance Compared to Deuterium Dilution for Assessment of Total Body Water
SPECIFIC AIM:
Determine the validity of the Biospace bioelectrical impedance devices compared to deuterium water (D2O) measurements.
HYPOTHESIS:
The Biospace Body Composition Analyzers are valid tools for measuring total body water and body composition.
- Conditions
- Total Body Water Assessment
- Being tested
- observation
- Keywords
- multi-frequency, bioelectrical impedance, body composition, hydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
no intervention used, observed measurements from 3 test devices compared to reference criterion measurement for total body water and body composition
| Study group | Role | What they receive |
|---|---|---|
| otherwise healthy with various BMI | Not described Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Body Water differences between criterion and test devices
from BIA and from D2O
Measured: Baseline only
Secondary outcomes (4)
Total lean body mass differences between criterion and test devices
From BIA and from DXA
Measured: Baseline only
Appendicular lean mass differences between criterion and test devices
from BIA and from DXA
Measured: Baseline only
Trunk lean mass differences between criterion and test devices
from BIA and from DXA
Measured: Baseline only
Total fat mass differences between criterion and test devices
from BIA and from DXA
Measured: Baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Body Water AssessmentStudies 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 25 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607229
- Sponsor's protocol ID
- BIA-D2O-TBW
- Status last verified
- May 2012
- First submitted
- 8 May 2012
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Multi-frequency Bioelectrical Impedance Compared to Deuterium Dilution for Assessment of Total Body Water
- ClinicalTrials.gov ID
- NCT01607229
- Acronym / sponsor ID
- BIA-D2O-TBW
- Conditions
- Total Body Water Assessment
- Keywords
- multi-frequency, bioelectrical impedance, body composition, hydration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SPECIFIC AIM:
Determine the validity of the Biospace bioelectrical impedance devices compared to deuterium water (D2O) measurements.
HYPOTHESIS:
The Biospace Body Composition Analyzers are valid tools for measuring total body water and body composition.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| otherwise healthy with various BMI | – | Other: observation |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- community sample
Key inclusion criteria (1 listed)
- men and women between 18-59 years of age
Key exclusion criteria (4 listed)
- Acute illness (infection, recent surgery, trauma).
- pregnancy
- pacemaker or defibrillator
- We would like to standardize the procedures and measurements in the adult population first. Older adults are excluded because by including older adults at this time, we would need to increase the sample size because we believe older adults have greater fluctuations in hydration due to medications, diet, and co-morbidities.
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 |
|---|---|---|
| observationno intervention used, observed measurements from 3 test devices compared to reference criterion measurement for total body water and body composition | Other | otherwise healthy with various BMI |
Primary outcome
Total Body Water differences between criterion and test devices
Time frame: Baseline only
from BIA and from D2O
4 secondary outcomes
Total lean body mass differences between criterion and test devices
Time frame: Baseline only
Appendicular lean mass differences between criterion and test devices
Time frame: Baseline only
Trunk lean mass differences between criterion and test devices
Time frame: Baseline only
Total fat mass differences between criterion and test devices
Time frame: Baseline only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Body Water Assessment, 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 4 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 30 May 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Body Water differences between criterion and test devices (time frame: Baseline only). 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 30 May 2012.