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

May 24, 2012 updated by: Todd Schroeder, University of Southern California

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

community sample

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Body Water differences between criterion and test devices
Time Frame: Baseline only
from BIA and from D2O
Baseline only

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total lean body mass differences between criterion and test devices
Time Frame: Baseline only
From BIA and from DXA
Baseline only
Appendicular lean mass differences between criterion and test devices
Time Frame: Baseline only
from BIA and from DXA
Baseline only
Trunk lean mass differences between criterion and test devices
Time Frame: Baseline only
from BIA and from DXA
Baseline only
Total fat mass differences between criterion and test devices
Time Frame: Baseline only
from BIA and from DXA
Baseline only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

May 24, 2012

First Posted (Estimate)

May 30, 2012

Study Record Updates

Last Update Posted (Estimate)

May 30, 2012

Last Update Submitted That Met QC Criteria

May 24, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BIA-D2O-TBW

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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