Hydration Factor Study for the Stayhealthy BC3

Pilot Study for the Validation of the BC3 Bioelectrical Impedance Hydration Factor

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.

Study Overview

• Status: Completed
• Conditions: Body Composition
• Intervention / Treatment: Device: D2O

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
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC Clinical Exercise Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men and women 18-80 years of age

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Stayhealthy BC3 Body Composition Analyzer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Principal Investigator: Edward T Schroeder, PhD, University of Southern California

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: September 24, 2010
• First Submitted That Met QC Criteria: September 24, 2010
• First Posted (Estimated): September 27, 2010

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Body Fat; Total body water
• Other Study ID Numbers: Stayhealthy 02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No