Body Composition Clinical Trial
Official title:
Calorie Balance Monitoring and Analysis of Body Composition and Hydration
The investigators are developing two new medical instruments: 1. the Intelligent Sensor Belt
(ISB), and 2. the Body Composition and Hydration Status Analyzer (BC-HS-A). ISB serves the
purpose of measuring calorie/ energy consumption of the human body during physical activity.
The BC-HS-A measures the body composition, i.e. the fat and lean body mass and the hydration
status i.e the amount of water inside and outside of the body cells.
The goal of this pilot study is to obtain data from the investigators prototype medical
instruments: 1. ISB, and 2. BC-HS-A during physical exercise and compare those results with
readings of other commercially available instruments or exercise equipments. The
investigators would be testing for technical feasibility and, through comparison with
existing measuring devices, the reliability of the investigators prototype.
Our goal is the development of a non-invasive, Portable Comprehensive Metabolic Monitoring
System (PCMMS) for continuous measurement and monitoring of parameters of the human energy
metabolism.
The current project focuses on the development of two hardware components of PCMMS: 1. the
Intelligent Sensor Belt (ISB), and 2. the Body Composition (BC) & Hydration Status (HS)
Analyzer (BC--HS-A).
ISB is designed to be worn around the chest or waist and measures the energy expenditure of
physical activity (PAE) via sensors for heart rate, tri-axial acceleration, and temperature.
BC-HS-A utilizes multi-frequency bio-impedance measurements through electrodes attached to
one hand and opposite foot. This instrument is not used continuously but intermittently when
momentary values of BC and HS are desired.
This pilot study is designed to obtain data from our instruments during a limited exercise
session to gage its function and to determine its feasibility for the intended use. The
pilot study will be performed on healthy volunteers who would wear ISB during a graded
cardiac stress testing on various exercise machines such as the stationary bicycle,
treadmill, stair case, and rowing machine. PAE measured by ISB will be compared with the
estimated results of the particular exercise equipment. The BC measuring function of our
BC-HS-A will be compared with a commercially available bioimpedance analyzer. Changes of
hydration status during exercise measured by our BC-HS-A will be compared against precision
measurements of body weight before and after exercise estimating total water loss of the
body. All results will be reported in a peer-reviewed journal.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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