SedentaryNRG_DBSSNCT05832710
The Project NRG - Part 1: Validation of Methods for Estimating Resting Energy Expenditure
An observational study of Sedentary and Physical Activity, run by Dynamical Business and Science Society - DBSS International SAS at 2 sites in Colombia.
Trial summary
Total daily energy expenditure (TDEE) is known as the energy used by an organism during a day. The TDEE is divided into resting energy expenditure (REE), the thermic effect of food (TFE), and the energy expenditure of physical activity. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary, Physical Activity, Athletes
- How many people
- 90 participants
- Where
- 2 sitesColombia
- Study dates
- Sep 2023to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will be people between 18-60 years of age with different levels of physical activity, male and female residents of the cities of Medellin and Bogota. It will include residents of nearby municipalities that make up the metropolitan area of these cities (Andean Region of Colombia).
Who may be able to join
- 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.
Who cannot join
- people over 60 years of age
- people diagnosed with cardiometabolic or respiratory diseases.
- people with some type of musculoskeletal injury.
Trial locations and contacts
2 sites in 1 country.
Jorge L Petro, MSc contact
Colombia2 sites
Campus San Alberto Magno, Universidad Santo Tomás
Bogotá, 111166
Isabel A. Sánchez-Rojas, MSc, +57-3107542877, isabel.sanchez@usta.edu.co
Camilo A. Rincón-Yepes, BSc
CESNUTRAL, Universidad CES
Medellín, Antioquia, 050001
Katherine Franco-Hoyos, MSc, +57-3002719536, kfranco@ces.edu.co
Diego A. Restrepo-Botero, MD
About this study
Official title: Comparison of Methods to Estimate Resting Energy Expenditure in Population With Different Levels of Physical Activity.
Total daily energy expenditure (TDEE) is known as the energy used by an organism during a day. The TDEE is divided into resting energy expenditure (REE), the thermic effect of food (TFE), and the energy expenditure of physical activity. There are multiple methods of measuring REE (e.g., estimating equations, direct and indirect calorimetry) among which there are significant discrepancies in its calculation in specific populations. 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 cross-sectional-observational study will be carried out through the guidelines for strengthening the reporting of observational studies in nutritional epidemiology (STROBE-Nut). The study population will be 130 adults from the city of Medellín, Bogotá and metropolitan areas with different levels of physical activity according to the results of the International Physical Activity Questionnaire (IPA-Q) where a high (athletes), moderate (physically active people) and low (sedentary) categorization will be made, then the indirect calorimetry tests will be applied. 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.
Read the 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.
- Conditions
- Sedentary, Physical Activity, Athletes
- Keywords
- Energy Expenditure, Indirect Calorimetry, Basal Metabolism, Physical Activity, Validation Study
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sedentary | It will be obtained by open call for both students and administrative staff at the CES University (Medellín) and Universidad Santo Tomás (Bogotá). | |
| 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). | |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of resting energy expenditure.
The resting energy expenditure in subjects with different levels of physical activity will be obtained by means of indirect calorimetry.
Measured: August 2023 to December2023
Secondary outcomes (1)
Anthropometry-Based Analysis of Body Composition.
Musculoskeletal mass indicators will be obtained as a variable to estimate energy expenditure at rest and compare them with indirect calorimetry data.
Measured: August 2023 to December2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study startSep 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SedentaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dynamical Business and Science Society - DBSS International SAS
- Sponsor type
- Research network
- Collaborators
- CES University, Universidad Santo Tomas
- Responsible party
- Sponsor
- Investigators
- Jorge M Vélez-Gutiérrez, MSc, Principal investigator, ARTHROS Centro de Fisioterapia y Ejercicio, MedellínAndrés Rojas-Jaramillo, MSc, Principal investigator, INDEPORTES Antioquia, MedellínIsabel A Sánchez-Rojas, MSc, Principal investigator, GICAEDS, Universidad Santo Tomás, Bogotá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832710
- Sponsor's protocol ID
- Acta0043Proy191TG
- Other IDs
- NRG_DBSS
- Acronym
- NRG_DBSS
- Status last verified
- Sep 2023
- First submitted
- 15 Apr 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23443826Bonilla 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.
PubMed 36235712Herrera-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.
PubMed 34148529
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Methods to Estimate Resting Energy Expenditure in Population With Different Levels of Physical Activity.
- ClinicalTrials.gov ID
- NCT05832710
- Acronym / sponsor ID
- NRG_DBSS / Acta0043Proy191TG
- Conditions
- Sedentary, Physical Activity, Athletes
- Keywords
- Energy Expenditure, Indirect Calorimetry, Basal Metabolism, Physical Activity, Validation Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dynamical Business and Science Society - DBSS International SASResearch network
- Collaborators
- CES University, Universidad Santo Tomas
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total daily energy expenditure (TDEE) is known as the energy used by an organism during a day. The TDEE is divided into resting energy expenditure (REE), the thermic effect of food (TFE), and the energy expenditure of physical activity. There are multiple methods of measuring REE (e.g., estimating equations, direct and indirect calorimetry) among which there are significant discrepancies in its calculation in specific populations. 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 cross-sectional-observational study will be carried out through the guidelines for strengthening the reporting of observational studies in nutritional epidemiology (STROBE-Nut). The study population will be 130 adults from the city of Medellín, Bogotá and metropolitan areas with different levels of physical activity according to the results of the International Physical Activity Questionnaire (IPA-Q) where a high (athletes), moderate (physically active people) and low (sedentary) categorization will be made, then the indirect calorimetry tests will be applied. 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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sedentary | – | –It will be obtained by open call for both students and administrative staff at the CES University (Medellín) and Universidad Santo Tomás (Bogotá). |
| 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). |
| 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will be people between 18-60 years of age with different levels of physical activity, male and female residents of the cities of Medellin and Bogota. It will include residents of nearby municipalities that make up the metropolitan area of these cities (Andean Region of Colombia).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- people over 60 years of age
- people diagnosed with cardiometabolic or respiratory diseases.
- people with some type of musculoskeletal injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimation of resting energy expenditure.
Time frame: August 2023 to December2023
The resting energy expenditure in subjects with different levels of physical activity will be obtained by means of indirect calorimetry.
1 secondary outcome
Anthropometry-Based Analysis of Body Composition.
Time frame: August 2023 to December2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Background: PubMed 23443826Psota 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.
- Background: PubMed 36235712Bonilla 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.
- Background: PubMed 34148529Herrera-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.
- Research Division, DBSS InternationalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge L Petro, MSc contact
Jorge M Vélez-Gutiérrez, MSc principal investigator
ARTHROS Centro de Fisioterapia y Ejercicio, Medellín
Andrés Rojas-Jaramillo, MSc principal investigator
INDEPORTES Antioquia, Medellín
Isabel A Sánchez-Rojas, MSc principal investigator
GICAEDS, Universidad Santo Tomás, Bogotá
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedentary and Physical Activity, run by Dynamical Business and Science Society - DBSS International SAS at 2 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego A Bonilla, MSc (+57-3203352050, dabonilla@dbss.pro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of resting energy expenditure. (time frame: August 2023 to December2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05832710, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.