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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02981160
Acronym
Breezing
Enrollment
0
Registered
2016-12-05
Start date
2016-12-31
Completion date
2018-06-30
Last updated
2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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 The study will involve withdrawn of breath samples at resting conditions, and under diets or physical activities regimes.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

Interventions

OTHERDietary

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).

Sponsors

Arizona State University
CollaboratorOTHER
University of Arizona
CollaboratorOTHER
Banner Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improve weight loss measures12 monthsImprove 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026