NCT01607229

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

Enrollment Period

4 months

First QC Date

May 8, 2012

Last Update Submit

May 24, 2012

Conditions

Total Body Water Assessment

Keywords

multi-frequencybioelectrical impedancebody compositionhydration

Outcome Measures

Primary Outcomes (1)

  • Total Body Water differences between criterion and test devices

    from BIA and from D2O

    Baseline only

Secondary Outcomes (4)

  • Total lean body mass differences between criterion and test devices

    Baseline only

  • Appendicular lean mass differences between criterion and test devices

    Baseline only

  • Trunk lean mass differences between criterion and test devices

    Baseline only

  • Total fat mass differences between criterion and test devices

    Baseline only

Study Arms (1)

otherwise healthy with various BMI

Other: observation

Interventions

observationOTHER

no intervention used, observed measurements from 3 test devices compared to reference criterion measurement for total body water and body composition

otherwise healthy with various BMI

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • men and women between 18-59 years of age

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Physical Therapy

Study Record Dates

First Submitted

May 8, 2012

First Posted

May 30, 2012

Study Start

January 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations

US(1)