Body Composition Clinical Trial
— PCMMSOfficial 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.
Status | Suspended |
Enrollment | 10 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | McKee Gym of the Department of Nutrition and Exercise Physiology | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
Ori Diagnostic Instruments LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the measuring function of our prototype devices with that one of commercially available measuring instruments | The outcome is assessed within few weeks of actual testing | Yes |
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