Hydration Factor Study for the Stayhealthy BC3

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. Identifier: NCT01209936
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : April 4, 2017
Information provided by (Responsible Party):
Todd Schroeder, University of Southern California

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.

Condition or disease Intervention/treatment Phase
Body Composition Device: D2O Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Study Start Date : September 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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

Inclusion Criteria:

• Men and women 21-45 years of age

Exclusion Criteria:

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

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 identifier (NCT number): NCT01209936

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

Responsible Party: Todd Schroeder, Associate Professor, University of Southern California Identifier: NCT01209936     History of Changes
Other Study ID Numbers: Stayhealthy 02
First Posted: September 27, 2010    Key Record Dates
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