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

Obesity Clinical Trial

— Breezing  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02981160
• Other study ID #: Breezing Study
• Status: Withdrawn
• Phase: N/A
• First received: November 10, 2016
• Last updated: April 12, 2017
• Start date: December 2016
• Est. completion date: June 2018

Study information

• Verified date: April 2017
• Source: Banner Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 The study will involve withdrawn of breath samples at resting conditions, and under diets or physical activities regimes.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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Dietary
The REE testing will be done with the Breezing device, a breath analyzer developed at Arizona State University. The Breezing device is an indirect calorimetry analyzer that measures the rate of oxygen consumption and carbon dioxide production, and determines how much energy the body is burning (REE), and the type of nutrients the body uses to produce energy (energy source). The Breezing device is a cellphone-size, battery-operated, portable technology that syncs with smartphones and electronic pads. The patients will be asked to breathe into a mouthpiece connected to the Breezing device; the data will be then beamed wirelessly to the device. The breath analysis data will displayed on the screen in conjunction with an estimate of total calories burned each day (total energy expenditure, TEE).

Locations

Country	Name	City	State
United States	Banner Gateway Medical Center	Gilbert	Arizona
United States	Banner Estrella Medical Center	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Banner Health	Arizona State University, University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve weight loss measures	Improve weight loss from a standard weight loss program from a mobile breath analyzer device. The device may provide more precise information regarding the metabolic rate in bariatric patients, this device may better tailor patients preoperative diet and assist in monitoring their weight loss.	12 months