Validation of a Personal Breath Analyzer for Diet and Energy Expenditure Assessment and Management



Status:Withdrawn
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 50
Updated:4/14/2017
Start Date:December 2016
End Date:June 2018

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The purpose of the research is to determine energy expenditure rates and diet and/ physical
activity metabolic features of an individual using current state technologies and a new
technology created at the Center for Bioelectronics and Biosensors at ASU. This is a pilot
study which intent is to validate this device for use in the weight loss patient population.

This study will involve research of metabolic physiological parameters that are measured
through the breath of the individuals, together with other physical parameters (weight,
height, date of birth, fat and lean body composition via bio-impedance, heart rate, blood
pressure, and breathing rate) assessed in the clinic, and a questionnaire about diary
physical activities. The study will involve withdrawn of breath samples at resting
conditions, and under diets or physical activities regimes.

This instrument will assist our patients in terms of tailoring their diet/nutrition through
their weight loss journey prior and after surgery. As a new technology, it will be an
excellent tool for compliance assessment and engagement with the Weight Loss Program as well
as for long term follow up.

The Breezing® device is a new technology locally invented in the state of Arizona that uses
a sensor cartridge and a flow meter to determine the rate of consumed oxygen and produced
carbon dioxide in the breath. The sensing technology of the new indirect calorimeter, which
used a cell-phone camera as the optical detector. The current Breezing® device uses a code
to carry calibration parameters of a single-use sensor cartridge, which can be scanned and
recognized by the mobile application (app). The device is 6.0 oz. (170 g), and 1.8 in × 2.1
in × 4.8 in (4.7 cm × 5.4 cm × 12.3 cm), and connects wirelessly to an iOS mobile device,
using Bluetooth 4.0 technology.

The mobile device (phone or tablet) receives data from the device, processes information,
and then provides test results and summaries through a graphic user interface. It determines
the energy expenditure from the measurement of VO2 and VCO2 according to the Weir equation,
along with RQ. In addition to the sensor cartridge, the Breezing® device is used with a
non-rebreathing 2-valvesmouthpiece.

This new device will provide a more precise information regarding metabolic rate in our
Bariatric Patients to better tailor their preoperative diet and monitor their weight loss.

Up to date, this device was never used or validated before in the Bariatric population under
this setting.

Inclusion Criteria:

- Females or Males between 18 and 50 yo

- Class II and Class III Obesity (BMI 35 and above)

Exclusion Criteria:

- No Obesity. Patients with normal BMI
We found this trial at
2
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1900 North Higley Road
Gilbert, Arizona 85234
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Gilbert, AZ
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Phoenix, Arizona 85037
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Phoenix, AZ
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