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.

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.

Study Overview

Status

Not yet recruiting

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

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Bogotá, Colombia, 111166
        • Campus San Alberto Magno, Universidad Santo Tomás
        • Contact:
        • Sub-Investigator:
          • Camilo A. Rincón-Yepes, BSc
    • Antioquia
      • Medellín, Antioquia, Colombia, 050001
        • CESNUTRAL, Universidad CES
        • Contact:
        • Sub-Investigator:
          • Diego A. Restrepo-Botero, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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).

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
August 2023 to December2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometry-Based Analysis of Body Composition.
Time Frame: August 2023 to December2023
Musculoskeletal mass indicators will be obtained as a variable to estimate energy expenditure at rest and compare them with indirect calorimetry data.
August 2023 to December2023

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of equations to estimate resting energy expenditure.
Time Frame: August 2023 to December2023
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.
August 2023 to December2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

April 15, 2023

First Submitted That Met QC Criteria

April 15, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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