NCT00823329

Calorie Balance Monitoring and Analysis of Body Composition and Hydration Status

Calorie Balance Monitoring and Analysis of Body Composition and Hydration

• Status: Suspended
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Ori Diagnostic Instruments LLC · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Energy Metabolism
• Energy Expenditure
• Body Composition
• Body Fluids

Interventions

Type	Name	Description
DEVICE	cardiac stress testing with an exercise machine	Standardized graded cardiac stress testing with an exercise machine will be performed according to the protocol of the American Heart Association

Timeline

• Start date: 2012-10-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2009-01-15
• Last updated: 2012-10-12

Locations

1 site across 1 country: United States