Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of British Columbia
Must not be taking: Energy balance, Sleep affecting
Disqualifiers: Cardiovascular disease, Diabetes, Cancer, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Obesity is a leading risk factor for chronic diseases such as type 2 diabetes, cancer, and cardiovascular disease. Generic weight management programs that target dietary intake and physical activity have been shown to be ineffective in maintaining weight loss beyond a 6-month period. Personalizing weight management programs produces more weight loss than generic programs, possibly through improved self-efficacy (confidence in one's ability to control weight through behavior). One way to personalize diet goals for individuals is by resting metabolic rate (RMR; 'metabolism'). This study will explore adherence and satisfaction of 6-weeks repeated at-home measures of metabolism using a portable device in healthy adults with and without obesity. Relationships among adherence and satisfaction outcomes to health behavior variables will be explored using dietary recalls, exercise monitors and questionnaires. Investigators will conduct a 6-week, one-arm feasibility study in order to address these questions. Twenty men and women ages 19-65 will be recruited (up to n=25 participants), among which 10 participants will have a body mass index (BMI) of ≥30kg/m2 (classified as having obesity), and the remaining 10 participants will have a body mass index (BMI) of \< 29.9kg/m2 (classified as not having obesity). The baseline study visit will evaluate participant's anthropometric measures, RMR using the ParvoMedics TrueOne 2400 and Breezing indirect calorimeters, psychological and behavioural related parameters. An activPAL device will be provided to measure participant physical activity. Completion of a 3-day diet record following the baseline study visit, in which participants keep a record of all food and beverages consumed over 2 weekdays and 1 weekend, is required. Participants will be asked to use the Breezing device from home to measure their RMR one time/week on the same day of the week (± one day) and at the same time each morning for six consecutive weeks following the baseline visit. A weekly Qualtrics survey will be sent to participants to monitor adherence. A follow-up visit after the six weeks will assess participant's body composition using a Dual X-ray Absorptiometry (DEXA), in addition to completion of a user satisfaction interview with a study team member for descriptive analysis. The measures taken at the baseline study visit will be repeated at the follow-up visit.
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 data supports the effectiveness of the Breezing Portable Indirect Calorimeter treatment for weight management?
The Breezing Portable Indirect Calorimeter is based on indirect calorimetry, which is a gold standard for measuring energy expenditure. This method helps customize a person's energy needs and nutrient delivery, potentially improving nutrition therapy outcomes and aiding in weight management.
12345Is the Breezing Portable Indirect Calorimeter safe for use in humans?
The Breezing Portable Indirect Calorimeter, also known as Breezing Med, has been validated for accuracy and reliability in measuring metabolic rates, and it has FDA clearance, indicating it meets safety standards for use in humans.
678910How does the portable device for weight management differ from other treatments?
This portable device for weight management is unique because it uses indirect calorimetry to measure resting metabolic rate (RMR), which helps tailor calorie intake for weight loss. Unlike traditional methods, this device is more affordable, convenient, and can be used in various settings, making it easier for individuals to manage their weight effectively.
2891112Eligibility Criteria
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
BMI over 18.5
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
+8 more
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)
Trial Timeline
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)
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Breezing Portable Indirect CalorimeterExperimental Treatment1 Intervention
Use Breezing to assess RMR once a week for six weeks
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of British Columbia - Okanagan CampusKelowna, Canada
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Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor
References
Indirect calorimetry: a practical guide for clinicians. [2017]This review provides clinicians with a comprehensive overview of indirect calorimetry including the principles, methodology, technologic advancements, benefits, and challenges. Clinical applications for indirect calorimetry and the potential limitations are specifically addressed for both the inpatient and outpatient setting. Measurement of energy expenditure is the most accurate method to assess energy needs. Indirect calorimetry remains a gold standard in measuring energy expenditure in the clinical settings. The benefits of providing optimal nutrition for recovery from illness and chronic health management are well documented. Indirect calorimetry offers a scientifically-based approach to customize a patient's energy needs and nutrient delivery to maximize the benefits of nutrition therapy. With recent advances in technology, indirect calorimeters are easier to operate, more portable, and affordable. Increased utilization of indirect calorimetry would facilitate individualized patient care and should lead to improved treatment outcomes.
Evaluation of the accuracy and precision of a new generation indirect calorimeter in canopy dilution mode. [2021]Indirect calorimetry (IC) is the only way to measure in real time energy expenditure (EE) and to optimize nutrition support in acutely and chronically ill patients. Unfortunately, most of the commercially available indirect calorimeters are rather complex to use, expensive and poorly accurate and precise. Therefore, an innovative device (Q-NRG®, COSMED, Rome, Italy) that matches clinicians' needs has been developed as part of the multicenter ICALIC study supported by the two academic societies ESPEN and ESICM. The aim of this study was to evaluate the accuracy and intra- and inter-unit precision of this new device in canopy dilution mode in vitro and in spontaneously breathing adults.
[Determinations by indirect calorimetry need not be expensive and technically complicated. A new measurement system and its validation]. [2006]Presentation of a newly conceived measuring instrument to determine the energy expenditure of critically ill patients at the bedside by means of indirect calorimetry. The special advantages of the measuring instruments are easy handling, little maintenance and very low working expenses and prime costs. The accuracy of measurement is considerable nd is comparable with that of other measuring methods, as has been established by an extensive validation.
Use of indirect calorimetry in clinical nutrition. [2017]The tremendous variability in resting energy expenditure makes efforts to predict caloric requirements difficult. Indirect calorimetry has provided a valuable tool in assessing energy expenditure, evaluating the way in which the body uses nutrient fuel, and designing nutritional regimens that best fit the clinical condition of the patient. The many indirect calorimetric instruments available vary in their application to clinical nutrition. The best metabolic studies are achieved by controlling the testing environment, accounting for the many clinical factors that may affect measurements, and eliminating potential sources for error. Although indirect calorimetry would seem to reduce the likelihood of complications from overfeeding, its greatest effect may be in cost savings by avoiding unnecessary nutritional support and in providing a means for clinical research.
Energy delivery guided by indirect calorimetry in critically ill patients: a systematic review and meta-analysis. [2021]The use of indirect calorimetry (IC) is increasing due to its precision in resting energy expenditure (REE) measurement in critically ill patients. Thus, we aimed to evaluate the clinical outcomes of an IC-guided nutrition therapy compared to predictive equations strategy in such a patient population.
Validation of an indirect calorimeter using n-of-1 methodology. [2020]Validation data for currently available indirect calorimeters is limited. The purpose of this investigation was to validate a newer indirect calorimeter system (Vmax Encore) against a criterion device (Deltatrac Metabolic Monitor) in spontaneously breathing mode.
Comparative study of a novel portable indirect calorimeter to a reference breath-by-breath instrument and its use in telemedicine settings. [2022]Label="BACKGROUND & AIMS">Resting Energy Expenditure (REE) quantitatively describes the calories used to support body function (e.g. breathing, blood circulation, etc.) at resting condition. Assessment of the REE is essential for successful weight management and the understanding of metabolic health. REE is typically determined via indirect calorimetry. Current biomedical indirect calorimetry technologies, utilizing assessment of oxygen consumption (VO2) and carbon dioxide production (VCO2) rates (which are typically in the form factor of a metabolic cart) are bulky and require on-site calibration and/or trained professionals to operate. We introduce a novel wearable medical device with FDA clearance to determine REE accurately, portable, and user-friendly format, which can be used both by health professionals in a clinical environment and by the patient at home. Previously, we have reported the validation of Breezing Med (also named as Breezing Pro™) through Douglas Bag Method, a gold standard for gas exchange measurement, and excellent agreement has been found between the two methods for the determination of REE, VO2, and VCO2 rates (Mora et al., 2020). Now we present the validation of Breezing Med against Medical Graphics (MGC) CPX Ultima™, a FDA 510 k cleared metabolic cart, which principle is based on breath-by-breath analysis. In addition, we present Breezing Med as a tool for daily measurement of metabolic rate by the lay person at home.
Systematic review on use of a handheld indirect calorimeter to assess energy needs in adults and children. [2022]With the number of individuals becoming overweight or obese, health care professionals are in need of accurate, reliable, and convenient tools to help personalize weight-loss programs. Recently, a new handheld indirect calorimeter (i.e., MedGem/BodyGem; also know as "Gem") was introduced as a convenient way to assess resting metabolic rate (RMR) to determine daily energy needs. Several validation and comparison studies were conducted to determine whether the Gem device is accurate and reliable, and results from these studies are mixed. Fourteen human studies (12 adult, 2 pediatric) were conducted, and 12 met the established criteria for this review. In all Douglas-bag (DB; n = 4) validation studies, the Gem device was not significantly different than the DB (mean difference adult +/-1%, pediatric +/-1%). The intraclass reliability of the Gem ranged from 0.97 to 0.98, and the interclass reliability to the DB ranged from 0.91 to 0.97. Although few (n = 2) studies have demonstrated that the Gem device measures RMR significantly lower (-8.2% to 15.1%) than traditional metabolic carts, it performs very comparably (RMR values 0.1-4.0%, interclass reliability 0.76-0.92) to traditional metabolic carts in most (n = 6) of the comparison studies. Based on these data, the Gem device is a valid and reliable indirect calorimeter for energy assessment in most adults and children.
Assessing Resting Metabolic Rate in Overweight and Obese Adolescents With a Portable Indirect Calorimeter: A Pilot Study for Validation and Reliability. [2017]Indirect calorimetry measured via the traditional indirect calorimeter is considered the "gold standard" for determining resting metabolic rate (RMR). Portable devices for assessing RMR are a less expensive option for measuring RMR in the clinical setting. This pilot study tested the reliability and validity of a portable device for measuring RMR, specifically in overweight and obese adolescents.
Validation of the BIOPAC indirect calorimeter for determining resting energy expenditure in healthy free-living older people. [2019]The BIOPAC indirect calorimeter for measuring resting energy expenditure (REE) is less cumbersome than many other calorimeters. We tested the hypothesis that the BIOPAC calorimeter is as well suited for determining REE in older people as traditional calorimeters. In 50 healthy persons (24 men and 26 women; age range, 61-83 years), REE by BIOPAC was validated against Vmax Spectra indirect calorimeter as a criterion method. Resting energy expenditure by BIOPAC was recorded at 2 different time intervals to find optimal conditions for older persons. Also, REE by 7 published equations was validated. The Bland-Altman procedure was used to test agreement between methods. Multiple regression analysis was applied to develop a new equation for predicting REE from BIOPAC. The BIOPAC calorimeter and most empirical equations significantly overpredicted mean REE in both sexes. Mifflin's equation best-predicted mean REE. Limits of agreement were wide for BIOPAC and narrow for most empirical equations. The Lührmann and Müller equations had smallest limits of agreement in men (+/-950 kJ/24 h) and the Harris-Benedict and Müller equations in women (+/-672 kJ/24 h). A new equation was developed for the BIOPAC device improving both predictions of mean and individual REE (R(2) = 0.671, standard error of the estimate = 136 kJ/24 h). Using this equation, 72.9% of subjects were lying within 10% of measured REE, compared with only 12.5% when using the manufacturer's algorithm. In conclusion, the BIOPAC calorimeter is suitable for measuring REE in healthy older adults when the new prediction equation is applied. This calorimeter is not applicable to frail older persons.
Monitoring energy metabolism with indirect calorimetry: instruments, interpretation, and clinical application. [2017]Indirect calorimetry is the best measure to guide calorie administration during nutrition support. This article presents an update of the types of currently available indirect calorimeters and reviews the recent advances that guide the clinical application of indirect calorimetry. The emphasis of this report is placed on issues that the practicing clinician can use to evaluate, interpret, and apply measurements of energy expenditure.
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. [2009]To compare standardized prediction equations to a hand-held indirect calorimeter in estimating resting energy and total energy requirements in overweight women.