Validation of the Stayhealthy BC1 Body Comp Analyzer

Body Composition Clinical Trial

Official title:

Validation of the BC1 Bioelectrical Impedance Body Comp Analyzer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209923
• Other study ID #: Stayhealthy 01
• Status: Completed
• Phase: N/A
• Start date: May 2007
• Est. completion date: August 2009

Study information

• Verified date: December 2021
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to validate the Stayhealthy BC1 bioelectrical impedance analyzer to assess percent body fat in children and adults. The BC1 was compared to dual-energy x-ray absorptiometry assessment of body fat for adults and to hydrostatic weighing assessment of body fat for children. We hypothesized that the BC1 would provide similar measures of body fat between devices with acceptable limits of agreement.

Description:

The BC1 body composition analyzer is manufactured by Stayhealthy. It is a handheld, noninvasive bioelectrical impedance device. When held, the BC1 sends an electrical impulse through the body to determine body fat, muscle mass, and 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, fat free body mass, and total body fat.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 80 Years

Eligibility

Inclusion Criteria:

• boys and girls 10-17 yrs and men and women 18-80 yrs

Exclusion Criteria:

• acute illness

• pregnancy

• pacemaker or defibrillator

Related Conditions & MeSH terms

• Body Composition

Intervention

Device:
• BC1
Body composition measures taken twice at the same visit for BIA, DEXA, and hydrostatic weighing.

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, 

References & Publications (1)

Erceg DN, Dieli-Conwright CM, Rossuello AE, Jensky NE, Sun S, Schroeder ET. The Stayhealthy bioelectrical impedance analyzer predicts body fat in children and adults. Nutr Res. 2010 May;30(5):297-304. doi: 10.1016/j.nutres.2010.04.009. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Body Fat	Percent body was compared between devices	2 measures were assessed during a single visit