Hydration Factor Study for the Stayhealthy BC3

Body Composition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209936
• Other study ID #: Stayhealthy 02
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: July 2010

Study information

• Verified date: December 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Men and women 18-80 years of age

Exclusion Criteria:

• Acute illness (infection, recent surgery, trauma).

• Pregnancy

• Pacemaker or defibrillator

Related Conditions & MeSH terms

• Body Composition

Intervention

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

Locations

Country	Name	City	State
United States	USC Clinical Exercise Research Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)