NRG_DBSS: The Project NRG - Part 1: Validation of Methods for Estimating Resting Energy Expenditure

Sponsor
Dynamical Business and Science Society - DBSS International SAS (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05832710
Collaborator
CES University (Other), Universidad Santo Tomas (Other)
90
2
5
45
9

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Comparison of Methods to Estimate Resting Energy Expenditure in Population With Different Levels of Physical Activity.
    Anticipated Study Start Date :
    Jul 1, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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).

    Outcome Measures

    Primary Outcome Measures

    1. Estimation of resting energy expenditure. [August 2023 to December2023]

      The resting energy expenditure in subjects with different levels of physical activity will be obtained by means of indirect calorimetry.

    Secondary Outcome Measures

    1. Anthropometry-Based Analysis of Body Composition. [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.

    Other Outcome Measures

    1. Development of equations to estimate resting energy expenditure. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CESNUTRAL, Universidad CES Medellín Antioquia Colombia 050001
    2 Campus San Alberto Magno, Universidad Santo Tomás Bogotá Colombia 111166

    Sponsors and Collaborators

    • Dynamical Business and Science Society - DBSS International SAS
    • CES University
    • Universidad Santo Tomas

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Dynamical Business and Science Society - DBSS International SAS
    ClinicalTrials.gov Identifier:
    NCT05832710
    Other Study ID Numbers:
    • Acta0043Proy191TG
    • NRG_DBSS
    First Posted:
    Apr 27, 2023
    Last Update Posted:
    Apr 27, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dynamical Business and Science Society - DBSS International SAS

    Study Results

    No Results Posted as of Apr 27, 2023