NCT05832710

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

April 15, 2023

Last Update Submit

September 5, 2023

Conditions

Keywords

Energy ExpenditureIndirect CalorimetryBasal MetabolismPhysical ActivityValidation Study

Outcome Measures

Primary Outcomes (1)

  • 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.

    August 2023 to December2023

Secondary Outcomes (1)

  • Anthropometry-Based Analysis of Body Composition.

    August 2023 to December2023

Other Outcomes (1)

  • Development of equations to estimate resting energy expenditure.

    August 2023 to December2023

Study Arms (3)

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).

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • people over 60 years of age
  • people diagnosed with cardiometabolic or respiratory diseases.
  • people with some type of musculoskeletal injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CESNUTRAL, Universidad CES

Medellín, Antioquia, 050001, Colombia

Location

Campus San Alberto Magno, Universidad Santo Tomás

Bogotá, 111166, Colombia

Location

Related Publications (3)

  • 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.

    PMID: 23443826BACKGROUND
  • 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.

    PMID: 36235712BACKGROUND
  • 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.

    PMID: 34148529BACKGROUND

Related Links

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego A Bonilla, MSc

CONTACT

Jorge L Petro, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2023

First Posted

April 27, 2023

Study Start

September 1, 2023

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations