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Calorie Balance Monitoring and Analysis of Body Composition and Hydration Status (PCMMS)

This study has suspended participant recruitment.
(lack of funding)
Sponsor:
Information provided by:
Ori Diagnostic Instruments LLC
ClinicalTrials.gov Identifier:
NCT00823329
First received: January 13, 2009
Last updated: October 10, 2012
Last verified: October 2012
History of Changes

January 13, 2009
October 10, 2012
October 2012
October 2012   (final data collection date for primary outcome measure)
Comparison of the measuring function of our prototype devices with that one of commercially available measuring instruments [ Time Frame: The outcome is assessed within few weeks of actual testing ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00823329 on ClinicalTrials.gov Archive Site
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Calorie Balance Monitoring and Analysis of Body Composition and Hydration Status
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.
Interventional
Phase 0
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Energy Metabolism
  • Energy Expenditure
  • Body Composition
  • Body Fluids
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
10
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • interested participants who have maintained the same weight for several months and are healthy, are not pregnant and not wanting to become pregnant during the study period, do not take any drugs, and exercise regularly to maintain their weight will be invited.

Exclusion Criteria:

  • patients taking medication for bodily illness/disease, women who are pregnant or wanting to become pregnant during the study period, and those who have not followed a regular exercise regimen will not be included in the trial
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00823329
ORI-DGI-001
No
Zsolt Ori, MD, MS, FACP, Ori Diagnostic Instruments L.L.C.
Ori Diagnostic Instruments LLC
Not Provided
Principal Investigator: Zsolt P Ori, MD Boone Hospital Center
Ori Diagnostic Instruments LLC
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP