NCT01209936

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable

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

September 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2010

Completed
13.2 years until next milestone

Results Posted

Study results publicly available

December 11, 2023

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

September 24, 2010

Results QC Date

May 19, 2022

Last Update Submit

December 7, 2023

Conditions

Keywords

Body FatTotal body water

Outcome Measures

Primary Outcomes (3)

  • Estimated Body Fat % for Children Aged 10-17 Years Old

    Stayhealthy BC3 was analyzed against hydrostatic weighing for children aged 10-17 years old

    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

    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.

    One time point (only one day visit)

Study Arms (1)

deuterium oxide and BC3

EXPERIMENTAL

Testing of total body water on the BC3 compared to total body water measured by deuterium oxide.

Device: D2O

Interventions

D2ODEVICE

All participants received deuterium oxide (D2O) and testing with the BC3 for the measurement of total body water.

Also known as: Stayhealthy BC3 Body Composition Analyzer
deuterium oxide and BC3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women 18-80 years of age

You may not qualify if:

  • Acute illness (infection, recent surgery, trauma).
  • Pregnancy
  • Pacemaker or defibrillator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC Clinical Exercise Research Center

Los Angeles, California, 90033, United States

Location

Results Point of Contact

Title
Dr. David Erceg
Organization
University of Southern California

Study Officials

  • Edward T Schroeder, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 24, 2010

First Posted

September 27, 2010

Study Start

September 1, 2009

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

December 11, 2023

Results First Posted

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations