Portable Device for Weight Management

Overseen By Sarah Purcell, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Energy balance, Sleep affecting

Disqualifiers: Cardiovascular disease, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a portable device designed to aid weight management by measuring metabolism (how the body burns calories) at home. The goal is to determine if the Breezing Portable Indirect Calorimeter helps individuals adhere to personalized weight loss plans and feel satisfied with the process. The trial seeks participants who can easily travel to study visits and exercise moderately less than 300 minutes per week. Participants will use the device weekly for six weeks and provide feedback on their experience. This study includes individuals with or without obesity, as defined by their body mass index (BMI). As an unphased trial, it offers a unique opportunity to contribute to innovative research in weight management technology.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using regular medication that affects energy balance or sleep, you may not be eligible to participate.

What prior data suggests that this portable device is safe for weight management?

A previous study demonstrated promising safety results for the Breezing Portable Indirect Calorimeter, a device that measures metabolism. It uses a small sensor to measure oxygen and carbon dioxide exhalation. The FDA has approved this device, confirming its safety and effectiveness for similar uses. Participants who used Breezing while following a structured weight management plan adhered to their plan 70% better and lost three times more weight than those who did not use it. No significant negative side effects have been reported, suggesting that Breezing is generally safe and well-tolerated for home metabolism monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Breezing Portable Indirect Calorimeter because it offers a new way to manage weight by accurately measuring resting metabolic rate (RMR) on a weekly basis. Unlike traditional methods, which often rely on indirect calculations or expensive lab equipment, this portable device provides an easy and convenient way to assess metabolism in real-time. This could lead to more personalized weight management plans, helping individuals adjust their diet and exercise routines based on precise metabolic data. By offering quick and accessible insights into one's metabolism, it has the potential to revolutionize how people approach weight loss and maintenance.

What evidence suggests that this portable device is effective for weight management?

Research has shown that the Breezing Portable Indirect Calorimeter, which participants in this trial will use, can significantly aid in weight loss. In one study, people using this device lost weight much faster (89%) compared to those who didn't use it (50%). Another study found that those using Breezing, along with a structured weight plan, lost three times more weight and adhered better to their plans than those who didn't use it. The device is simple to use at home, allowing for easy and regular tracking of metabolism, which is how the body uses energy. This suggests that Breezing can be a valuable tool for personalizing weight management and supporting weight loss efforts. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men and women aged 19-65 who are either classified as having obesity with a BMI of ≥30kg/m2 or not having obesity with a BMI <29.9kg/m2. Participants must be healthy adults willing to track their metabolism at home using the Breezing device weekly, keep a food diary, and wear an exercise monitor.

Inclusion Criteria

Access to a mobile device (i.e., smartphone or tablet) with reliable Bluetooth and Wi-Fi connection for the 6 week study duration

Ability to attend two in-person sessions at UBCO

Ability and willingness to fast for 12 hours before each study day visit and at least once a week before completing RMR measures using the portable indirect calorimeter

Exclusion Criteria

I have or had major health issues like heart disease, diabetes, cancer, HIV, or others.

Currently or in the past six months: use of regular medication that may affect energy balance, or sleep, regular use of tobacco or nicotine products, starting any new prescription medication within two weeks of the first study day visit or planning to do so during the study, working night shifts or traveling across more than two time zones within two weeks of and throughout the study, history of surgical procedure for weight loss at any time (e.g., gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve); history of extensive bowel resection for other reasons, current alcohol or substance abuse (score ≥ 15 on the Alcohol Use Disorders Identification Test (AUDIT) 32, current or past history of eating disorders including anorexia nervosa, bulimia, binge eating disorder (self-report or score >20 on the Eating Attitudes Test - 26 (EATS-26) questionnaire) 33, current symptoms of depression (score ≥ 10 on the Center for Epidemiological Studies Depression Scale, 10-item version (CES-D-10))34, weight loss >5kg in past 12 weeks for any reason, weight loss of >20 kgs in past 3 years for any reason, degree or previous work experience (in the past 10 years) in fields highly related to energy balance (e.g., those exercise or nutrition)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including anthropometric measures, RMR using ParvoMedics and Breezing devices, and psychological and behavioral questionnaires.

1 day

1 visit (in-person)

Treatment

Participants use the Breezing device to measure RMR weekly at home for six weeks, complete weekly Qualtrics surveys, and use activPAL activity monitors.

6 weeks

6 visits (virtual)

Follow-up

Participants undergo follow-up assessments including body composition using DEXA, repeat RMR measurements, and user satisfaction interviews.

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Breezing Portable Indirect Calorimeter

Trial Overview The study tests how feasible and satisfying it is for participants to use the Breezing Portable Indirect Calorimeter at home over six weeks to measure their resting metabolic rate (RMR). It also examines how this self-monitoring relates to diet, physical activity, and psychological factors.

How Is the Trial Designed?

Group I: Breezing Portable Indirect Calorimeter Experimental Treatment 1 Intervention

Use Breezing to assess RMR once a week for six weeks

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

The Q-NRG® indirect calorimeter demonstrated high accuracy in measuring oxygen consumption (VO2), carbon dioxide production (VCO2), and energy expenditure (EE), with measurement errors of less than 1% in vitro and minimal differences compared to mass spectrometry in vivo.

The device showed excellent intra- and inter-unit precision, with coefficients of variation (CV%) of ≤1% for VO2 and EE, indicating it is a reliable tool for real-time energy expenditure measurement in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the accuracy and precision of a new generation indirect calorimeter in canopy dilution mode. Delsoglio, M., Dupertuis, YM., Oshima, T., et al.[2021]

Indirect calorimetry is a valuable tool for accurately assessing resting energy expenditure, which helps in designing personalized nutritional regimens for patients based on their specific clinical conditions.

By controlling the testing environment and accounting for clinical factors, indirect calorimetry can reduce complications from overfeeding and lead to cost savings by avoiding unnecessary nutritional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of indirect calorimetry in clinical nutrition. McClave, SA., Snider, HL.[2017]

Indirect calorimetry (IC) significantly improves energy delivery in critically ill patients, leading to a reduction in short-term mortality compared to traditional predictive equations, based on a meta-analysis of 8 randomized controlled trials involving 991 adults.

The use of IC-guided nutrition did not increase the duration of mechanical ventilation or length of ICU and hospital stays, and the rate of adverse events was similar between IC and control groups, suggesting it is a safe and effective approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy delivery guided by indirect calorimetry in critically ill patients: a systematic review and meta-analysis. Duan, JY., Zheng, WH., Zhou, H., et al.[2021]

Indirect calorimetry is the gold standard for accurately measuring energy expenditure in clinical settings, which is crucial for assessing patients' energy needs and optimizing nutrition therapy.

Recent technological advancements have made indirect calorimeters more user-friendly, portable, and affordable, encouraging their increased use to enhance individualized patient care and improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indirect calorimetry: a practical guide for clinicians. Haugen, HA., Chan, LN., Li, F.[2017]

In a study of 39 overweight women, the hand-held indirect calorimeter provided significantly different estimates of resting energy expenditure (REE) and total energy expenditure (TEE) compared to standardized prediction equations, indicating a lack of agreement between the two methods.

Less than 50% of the prediction equation values were within 10% of the calorimeter measurements, suggesting that these equations may not be reliable for accurately estimating energy needs in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand-held indirect calorimeter offers advantages compared with prediction equations, in a group of overweight women, to determine resting energy expenditures and estimated total energy expenditures during research screening. Spears, KE., Kim, H., Behall, KM., et al.[2009]

The Breezing Med device, a novel wearable technology, has been validated against the FDA-cleared MGC CPX Ultima metabolic cart for accurately measuring Resting Energy Expenditure (REE), showing strong correlation and equivalence in results.

This device is user-friendly and can be used at home, making it particularly valuable for telemedicine applications, especially during the COVID-19 pandemic and for individuals with limited access to healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of a novel portable indirect calorimeter to a reference breath-by-breath instrument and its use in telemedicine settings. Mora, SJ., Sprowls, M., Tipparaju, VV., et al.[2022]

The Vmax Encore indirect calorimeter is precise for measuring oxygen consumption (VO2) and resting metabolic rate (RMR) in spontaneously breathing individuals, with minimal differences from the Deltatrac device (4.5% lower for VO2 and 4.1% lower for RMR).

However, both devices showed imprecision in measuring carbon dioxide production (VCO2) and respiratory quotient (RQ), with significant discrepancies in 10% or more of the measurement pairs, indicating a limitation in their accuracy for these parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of an indirect calorimeter using n-of-1 methodology. Frankenfield, DC., Ashcraft, CM., Wood, C., et al.[2020]

Indirect calorimetry is identified as the most effective method for determining calorie needs during nutrition support, ensuring patients receive appropriate energy intake.

The article reviews advancements in indirect calorimetry technology and provides practical guidance for clinicians on how to accurately evaluate and apply energy expenditure measurements in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring energy metabolism with indirect calorimetry: instruments, interpretation, and clinical application. Holdy, KE.[2017]

The Gem handheld indirect calorimeter has been validated in 12 studies, showing it is accurate in measuring resting metabolic rate (RMR) with a mean difference of less than 1% compared to Douglas-bag methods, indicating its reliability for assessing daily energy needs.

While some studies suggest the Gem may measure RMR slightly lower than traditional metabolic carts, it generally performs comparably, making it a valid tool for energy assessment in both adults and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review on use of a handheld indirect calorimeter to assess energy needs in adults and children. McDoniel, SO.[2022]

A pilot study involving 19 overweight and obese adolescents found that a portable indirect calorimeter reliably measures resting metabolic rate (RMR), showing no significant difference compared to the traditional indirect calorimeter (P = .22).

The portable device demonstrated a high reliability with an intraclass correlation coefficient of 0.91, suggesting it is a valid alternative for assessing RMR in clinical settings for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Resting Metabolic Rate in Overweight and Obese Adolescents With a Portable Indirect Calorimeter: A Pilot Study for Validation and Reliability. Henes, ST., Johnson, A., Toner, M., et al.[2017]

A new bedside measuring instrument for indirect calorimetry has been developed to accurately assess energy expenditure in critically ill patients, offering a practical solution for healthcare providers.

This instrument is user-friendly, requires minimal maintenance, and has low operational costs, while its accuracy is validated to be comparable to existing measurement methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Determinations by indirect calorimetry need not be expensive and technically complicated. A new measurement system and its validation]. Höltermann, W., Leuchter, L., Lukasewitz, P., et al.[2006]

The BIOPAC indirect calorimeter is effective for measuring resting energy expenditure (REE) in healthy older adults, especially when using a newly developed prediction equation that improved accuracy significantly, with 72.9% of subjects' REE measurements falling within 10% of the actual values.

However, the BIOPAC calorimeter is not suitable for use in frail older individuals, indicating that while it is a good tool for healthy seniors, caution is needed when considering its application in more vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the BIOPAC indirect calorimeter for determining resting energy expenditure in healthy free-living older people. Khalaj-Hedayati, K., Bosy-Westphal, A., Müller, MJ., et al.[2019]

Citations

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Study of the Effect of Mobile Indirect Calorimeter on Weight ... The results indicated that the use of the mobile indirect calorimeter in the IG had positive effects on weight loss rate (89% in the IG vs. 50% in the CG, p = ...

2. breezing.com breezing.com/wp-content/uploads/2020/02/study-of-the-effect-of-mobile-indirect-calorimeter-on-weight-management.pdf

Study of the Effect of Mobile Indirect Calorimeter on Weight ... The results indicated that the use of the mobile indirect calorimeter in the IG had positive effects on weight loss rate (89% in the IG vs. 50% ...

3. breezing.com breezing.com/wp-content/uploads/2023/11/Breezing-Data-Sheets-11-16-2023-1.pdf

Gold Standard - Indirect Calorimetry Individuals using Breezing, while following a structured weight management plan, showed 70% greater adherence and 3x greater weight loss compared to a control ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405457721010597

Comparative study of a novel portable indirect calorimeter ... Results were recorded and analyzed for variability. The pilot study demonstrated the advantage of Breezing Med device to be easy-to-use at home by lay people, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9851426/

Feasibility and user acceptability of Breezing™, a mobile ... The purpose of this study was to examine the feasibility and user acceptability of Breezing™ to assess REE in pregnant women with overweight or obesity ...

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Breezing: Metabolic Rate Analysis Device | Respiratory ... Through indirect calorimetry using a single stamp-sized sensor cartridge, Breezing precisely measures both oxygen (O2) and carbon dioxide (CO2). Breezing's FDA- ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K200076.pdf

K200076 - Roberta (Bobbi) Druyor-Sanchez Regulatory ... Breezing MedTM is a stand-alone and fully integrated mask-like wearable metabolic analyzer based on the principle of indirect calorimetry, which ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0261561422001807

Clinical evaluation of the new indirect calorimeter in ... The primary objective was to assess the minimum time required to perform REE measurement in canopy and face mask mode with Q-NRG® compared to Quark RMR® (COSMED ...