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Hydration Factor Study for the Stayhealthy BC3

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01209936
First Posted: September 27, 2010
Last Update Posted: April 4, 2017
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
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.

Condition Intervention
Body Composition Device: D2O

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pilot Study for the Validation of the BC3 Bioelectrical Impedance Hydration Factor

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Total body water [ Time Frame: 6 months ]
    Total body water will be estimated by the BC3 bioelectrical impedance device and compared to total body water measured by deuterium oxide studies.


Enrollment: 15
Study Start Date: September 2009
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: deuterium oxide and BC3
Testing of total body water on the BC3 compared to total body water measured by deuterium oxide.
Device: D2O
All participants received deuterium oxide (D2O) and testing with the BC3 for the measurement of total body water.
Other Name: Stayhealthy BC3 Body Composition Analyzer

Detailed Description:

The BC3 body composition analyzer is manufactured by Stayhealthy. It is a handheld, noninvasive bioelectrical impedance device. When held, the BC3 sends an electrical impulse through the body to determine body fat, lean mass, and total body hydration. Bio-impedance devices measure the change in electrical resistance in body tissues by using a detectable electrical signal that passes through the body. The method is based on the principle that lean body mass contains virtually all the water and conducting electrolytes in the body and provides a good electrical pathway. In contrast, fat or fat-containing tissues produce a poor electrical pathway. By inducing a low-energy, high-frequency signal, a measurement of the baseline resistance to flow of electrical current can be assessed. The resistance measurement relates directly to the volume of the conductor. Through repeated measurements and identifying other parameters (i.e. gender, weight, age and height) proprietary equations were developed that determine total body water, lean mass, and % body fat.

The purpose of this study is to validate the calculated hydration factor produced by the BC3 bioelectrical impedance device. If this value is valid and comparable to the gold standard (D20) then this hydration factor will offer a very quick and inexpensive method to determine total body hydration status using a hand-held bioelectrical impedance device.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

• Men and women 21-45 years of age

Exclusion Criteria:

  • Acute illness (infection, recent surgery, trauma).
  • Pregnancy
  • Pacemaker or defibrillator
  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): NCT01209936


Locations
United States, California
USC Clinical Exercise Research Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Edward T Schroeder, PhD University of Southern California
  More Information

Responsible Party: Todd Schroeder, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT01209936     History of Changes
Other Study ID Numbers: Stayhealthy 02
First Submitted: September 24, 2010
First Posted: September 27, 2010
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Todd Schroeder, University of Southern California:
Body Fat
Total body water

Additional relevant MeSH terms:
Deuterium Oxide
Antineoplastic Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs