- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05832710
The Project NRG - Part 1: Validation of Methods for Estimating Resting Energy Expenditure (NRG_DBSS)
Comparison of Methods to Estimate Resting Energy Expenditure in Population With Different Levels of Physical Activity.
Study Overview
Status
Conditions
Detailed Description
Determination of the total daily energy expenditure (TDEE) is of great importance as a starting point for professional support and the achievement of physical, aesthetic, and health goals. Considering that TDEE is mainly composed of resting energy expenditure (REE), nutrition and health professionals generally estimate REE and then add values for the thermic effect of food (TFE) and physical activity expenditure. As well as allostatic load and stress may increase the REE, depending on the intensity and duration of the stressor. Based on predictor variables, REE estimating equations are used. However, the values yielded by the estimating equations can be inaccurate due to variations in the characteristics of the population. Considering the lack of validation in the Colombian population to estimate the REE, the objective of the present research study is to compare the methods for estimating resting energy expenditure in the Colombian population with different levels of physical activity. This is a cross-sectional-observational study that will be carried out by means of the guidelines for strengthening the reporting of observational studies in nutritional epidemiology (STROBE-Nut). Likewise, the data collection will be carried out with a pilot test where ISAK-certified personnel in levels 2 and 3 will offer specialized training to the research assistants to allow standardization in the taking of anthropometric measurements, which minimizes the error in the data collection. This process prior to data collection allows adjustment of the methodology and procedures during the research. In addition, technical staff with a master's degree in sports science, a master's degree in exercise physiology, or a medical degree will be available for the measurement of the REE by indirect calorimetry. The measurement will be performed after device calibration and a pilot test will be performed to standardize the work methodology and calculate the coefficient of variation of the equipment.
The NRG project is developed by the Research Division of the Dynamical Business & Science Society-DBSS International with the support of University CES, University of Cordoba, the R&D department of ARTHROS IPS, Smart Fit, INDEPORTES Antioquia, and the University Santo Tomás in Bogotá. The development of the equation to estimate the REE will be carried out with multiple regression models under traditional and Bayesian approaches with three independent variables. It is expected to obtain a simple and valid equation to estimate the REE and contribute to the good practices of Colombian practitioners in health sciences, exercise, and sports.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Diego A Bonilla, MSc
- Phone Number: +57-3203352050
- Email: dabonilla@dbss.pro
Study Contact Backup
- Name: Jorge L Petro, MSc
- Email: jlpetro@dbss.pro
Study Locations
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Bogotá, Colombia, 111166
- Campus San Alberto Magno, Universidad Santo Tomás
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Contact:
- Isabel A. Sánchez-Rojas, MSc
- Phone Number: +57-3107542877
- Email: isabel.sanchez@usta.edu.co
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Sub-Investigator:
- Camilo A. Rincón-Yepes, BSc
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Antioquia
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Medellín, Antioquia, Colombia, 050001
- CESNUTRAL, Universidad CES
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Contact:
- Katherine Franco-Hoyos, MSc
- Phone Number: +57-3002719536
- Email: kfranco@ces.edu.co
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Sub-Investigator:
- Diego A. Restrepo-Botero, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Over 18 years of age.
- Sedentary subjects, physically active individuals, and competitive athletes.
- Signed informed consent
- Residing in the city of Medellín or Bogotá and nearby municipalities of the metropolitan areas.
Exclusion Criteria:
- people over 60 years of age
- people diagnosed with cardiometabolic or respiratory diseases.
- people with some type of musculoskeletal injury.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Sedentary
It will be obtained by open call for both students and administrative staff at the CES University (Medellín) and Universidad Santo Tomás (Bogotá).
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Physically active
A sample of physical education majors and personal trainers who reside and work in Medellín and Bogotá will be invited to participate (Universidad Santo Tomás and Smart Fit).
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Professional Athletes
A sample of elite and sub-elite athletes with >2 years at the competitive level will be invited to participate (ARTHROS Physiotherapy and Exercise Center, INDEPORTES Antioquia, and Universidad Santo Tomás).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Estimation of resting energy expenditure.
Time Frame: August 2023 to December2023
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The resting energy expenditure in subjects with different levels of physical activity will be obtained by means of indirect calorimetry.
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August 2023 to December2023
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Anthropometry-Based Analysis of Body Composition.
Time Frame: August 2023 to December2023
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Musculoskeletal mass indicators will be obtained as a variable to estimate energy expenditure at rest and compare them with indirect calorimetry data.
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August 2023 to December2023
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Development of equations to estimate resting energy expenditure.
Time Frame: August 2023 to December2023
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It will be carried out with multiple regression models multiple regression models under traditional and Bayesian approaches with three independent variables, to obtain equations that can improve the estimates of resting energy expenditure.
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August 2023 to December2023
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Collaborators and Investigators
Investigators
- Principal Investigator: Jorge M Vélez-Gutiérrez, MSc, ARTHROS Centro de Fisioterapia y Ejercicio, Medellín
- Principal Investigator: Andrés Rojas-Jaramillo, MSc, INDEPORTES Antioquia, Medellín
- Principal Investigator: Isabel A Sánchez-Rojas, MSc, GICAEDS, Universidad Santo Tomás, Bogotá
Publications and helpful links
General Publications
- Psota T, Chen KY. Measuring energy expenditure in clinical populations: rewards and challenges. Eur J Clin Nutr. 2013 May;67(5):436-42. doi: 10.1038/ejcn.2013.38. Epub 2013 Feb 27.
- Bonilla DA, Duque-Zuluaga LT, Munoz-Urrego LP, Franco-Hoyos K, Agudelo-Martinez A, Kammerer-Lopez M, Petro JL, Kreider RB. Development and Validation of a Novel Waist Girth-Based Equation to Estimate Fat Mass in Young Colombian Elite Athletes (F20CA Equation): A STROSA-Based Study. Nutrients. 2022 Sep 29;14(19):4059. doi: 10.3390/nu14194059.
- Herrera-Amante CA, Ramos-Garcia CO, Alacid F, Quiroga-Morales LA, Martinez-Rubio AJ, Bonilla DA. Development of alternatives to estimate resting metabolic rate from anthropometric variables in paralympic swimmers. J Sports Sci. 2021 Sep;39(18):2133-2143. doi: 10.1080/02640414.2021.1922175. Epub 2021 Jun 20.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Acta0043Proy191TG
- NRG_DBSS (Other Identifier: DBSS International SAS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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