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
  Purpose

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.


Condition Intervention Phase
Energy Metabolism
Energy Expenditure
Body Composition
Body Fluids
Device: cardiac stress testing with an exercise machine
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Calorie Balance Monitoring and Analysis of Body Composition and Hydration

Resource links provided by NLM:


Further study details as provided by Ori Diagnostic Instruments LLC:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: October 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823329

Locations
United States, Missouri
McKee Gym of the Department of Nutrition and Exercise Physiology
Columbia, Missouri, United States, 656211
Sponsors and Collaborators
Ori Diagnostic Instruments LLC
Investigators
Principal Investigator: Zsolt P Ori, MD Boone Hospital Center
  More Information

No publications provided

Responsible Party: Zsolt Ori, MD, MS, FACP, Ori Diagnostic Instruments L.L.C.
ClinicalTrials.gov Identifier: NCT00823329     History of Changes
Other Study ID Numbers: ORI-DGI-001
Study First Received: January 13, 2009
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ori Diagnostic Instruments LLC:
measurement of energy expenditure of physical activity
analysis of body composition and hydration status

ClinicalTrials.gov processed this record on July 23, 2014