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Multi-frequency Bioelectrical Impedance for Estimating Total Body Water by Deuterium Dilution

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01607229
First Posted: May 30, 2012
Last Update Posted: May 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Todd Schroeder, University of Southern California
  Purpose

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.


Condition Intervention
Total Body Water Assessment Other: observation

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Utility of Multi-frequency Bioelectrical Impedance Compared to Deuterium Dilution for Assessment of Total Body Water

Resource links provided by NLM:


Further study details as provided by Todd Schroeder, University of Southern California:

Primary Outcome Measures:
  • Total Body Water differences between criterion and test devices [ Time Frame: Baseline only ]
    from BIA and from D2O


Secondary Outcome Measures:
  • Total lean body mass differences between criterion and test devices [ Time Frame: Baseline only ]
    From BIA and from DXA

  • Appendicular lean mass differences between criterion and test devices [ Time Frame: Baseline only ]
    from BIA and from DXA

  • Trunk lean mass differences between criterion and test devices [ Time Frame: Baseline only ]
    from BIA and from DXA

  • Total fat mass differences between criterion and test devices [ Time Frame: Baseline only ]
    from BIA and from DXA


Enrollment: 25
Study Start Date: January 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
otherwise healthy with various BMI Other: observation
no intervention used, observed measurements from 3 test devices compared to reference criterion measurement for total body water and body composition

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample
Criteria

Inclusion Criteria:

  • men and women between 18-59 years of age

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607229


Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
  More Information

Responsible Party: Todd Schroeder, Assistant Professor of Clinical Physical Therapy, University of Southern California
ClinicalTrials.gov Identifier: NCT01607229     History of Changes
Other Study ID Numbers: BIA-D2O-TBW
First Submitted: May 8, 2012
First Posted: May 30, 2012
Last Update Posted: May 30, 2012
Last Verified: May 2012

Keywords provided by Todd Schroeder, University of Southern California:
multi-frequency
bioelectrical impedance
body composition
hydration