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Completed

NCT Number: NCT01209936

Hydration Factor Study for the Stayhealthy BC3

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USC Clinical Exercise Research Center

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women 18-80 years of age

Exclusion criteria

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

Treatment and study plan

D2O

Device

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

Primary outcomes

  1. Estimated Body Fat % for Children Aged 10-17 Years Old

    Time frame: One time point (only one day visit)

    Stayhealthy BC3 was analyzed against hydrostatic weighing for children aged 10-17 years old

  2. Percent Body Fat in Women Aged 18-80 Years Old

    Time frame: One time point (only one day visit)

    Body fat percentage was measured via Stayhealthy BC3 as well as a full body DXA

  3. Estimated Percent Body Fat for Men Aged 18-80

    Time frame: One time point (only one day visit)

    The body fat percentage as estimated from BC3 and as calculated by a full body DXA.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 27, 2010
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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