Clinical trial NCT02981160: Validation of a Personal Breath Analyzer for Diet and Energy Expenditure Assessment and Management
Official title: Validation of a Personal Breath Analyzer for Diet and Energy Expenditure Assessment and Management
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Lead sponsor: Banner Health
Sponsor class: OTHER
Collaborators: name: Arizona State University
name: University of Arizona
First posted: 2016-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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 The study will involve withdrawn of breath samples at resting conditions, and under diets or physical activities regimes.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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improve weight loss measures
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner Gateway Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Banner Estrella Medical Center
state: Arizona
Study officials:
References: