Calorie Balance Monitoring and Analysis of Body Composition and Hydration Status - Full Text View

Sponsored by:	Ori Diagnostic Instruments LLC
Information provided by:	Ori Diagnostic Instruments LLC
ClinicalTrials.gov Identifier:	NCT00823329

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	Other: cardiac stress testing with an exercise machine	Phase 0

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Calorie Balance Monitoring and Analysis of Body Composition and Hydration

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

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:	September 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Contacts

Contact: Zsolt P Ori, MD	573-815-2232	zsolt.ori56@gmail.com
Contact: Ilona Ori, BA	573-808-2952	ilona@uchicago.edu

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:	Ori Diagnostic Instruments L.L.C. ( Zsolt Ori, MD, MS, FACP )
Study ID Numbers:	ORI-DGI-001
Study First Received:	January 13, 2009
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00823329 History of Changes
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 September 01, 2009