NCT04478565

Brief Summary

To our knowledge no study has evaluated neither feasible methods for the assessment of anthropometric profile nor indirect methods to estimate energy expenditure (EE) for adapted athletes. The primary aim is to develop and validate new RMR prediction models, for the estimation of the resting metabolic rate from anthropometric variables in young Mexican Paralympic athletes; our second objective is to evaluate the agreement between RMR and the prediction models of Cunningham, Harris-Benedict, Henry, Valencia, Chun, Nightingale \& Gorgey, FAO/WHO, Mifflin, Müller, Owen, and our own models. A comparative cross-sectional quantitative study was designed. Participants report to the testing laboratory only once for data collection. The Strengthening the Reporting of Observational Studies in Epidemiology criteria guidelines for cross-sectional research (STROBE) is followed in the design/reporting of this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

Same day

First QC Date

July 16, 2020

Last Update Submit

July 16, 2020

Conditions

Keywords

AnthropometryIndirect CalorimetryBioenergeticsMetabolic rateParalympic Athletes

Outcome Measures

Primary Outcomes (2)

  • Indirect Calorimetry

    The RMR was measured by IC using a portable device (Breezing®, Arizona, USA), which was calibrated before each test and has been described as a valid and reliable system (Xiaojun et al. 2015). RMR was calculated by breath oxygen consumption (O2 in mL·min-1), minute by minute, using the Weir equation (1949), while participants remained in a sitting position for ≈15 to 20 minutes.

    One day

  • Anthropometry

    The anthropometric measurements were performed by certified level 3 anthropometrists following the guidelines of the International Society for the Advancement of Kinanthropometry, ISAK (Stewart et al, 2011).

    One day

Interventions

RMR was calculated by breath oxygen consumption (O2 in mL·min-1), minute by minute, using a portable device (Breezing®, Arizona, USA), and the Weir equation (1949), while participants remained in a sitting position for ≈15 to 20 minutes. The anthropometric measurements were performed by certified level 3 anthropometrists following the guidelines of the International Society for the Advancement of Kinanthropometry, ISAK

Also known as: Anthropometry

Eligibility Criteria

Age10 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Mexican Paralympic swimmers from the national and the state adapted swimming team.

You may qualify if:

  • i) swimmers who report to the assessment area with a fasting period of 6 to 8 hours, and at least 12 hours after their last exercise routine; ii) swimmers who have not consumed alcohol or any stimulant for the last 48 hours (e.g., coffee, tea, chocolate, carbonated drinks, energy drinks, supplements); iii) swimmers who has contested at least in one of the last two swimming competitions, including World Championships and Paralympic Games

You may not qualify if:

  • i) fail to complete the indirect calorimetry test after two attempts; ii) attend to the evaluation area without the appropriate clothing or without following the instructions for fasting, exercise, and feeding prior to the evaluations; iii) swimmers who at the time of the evaluations did not give written consent (parental consent in case of under 18 years old) for procedures or data release for research purposes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iberoamerican Institute of Sports Science and Human Movement

Zapopan, Jalisco, 45128, Mexico

Location

Related Publications (9)

  • Chun SM, Kim HR, Shin HI. Estimating the Basal metabolic rate from fat free mass in individuals with motor complete spinal cord injury. Spinal Cord. 2017 Sep;55(9):844-847. doi: 10.1038/sc.2017.53. Epub 2017 May 23.

  • Cunningham JJ. A reanalysis of the factors influencing basal metabolic rate in normal adults. Am J Clin Nutr. 1980 Nov;33(11):2372-4. doi: 10.1093/ajcn/33.11.2372.

  • Harris JA, Benedict FG. A Biometric Study of Human Basal Metabolism. Proc Natl Acad Sci U S A. 1918 Dec;4(12):370-3. doi: 10.1073/pnas.4.12.370. No abstract available.

  • Henry CJ. Basal metabolic rate studies in humans: measurement and development of new equations. Public Health Nutr. 2005 Oct;8(7A):1133-52. doi: 10.1079/phn2005801.

  • Mifflin MD, St Jeor ST, Hill LA, Scott BJ, Daugherty SA, Koh YO. A new predictive equation for resting energy expenditure in healthy individuals. Am J Clin Nutr. 1990 Feb;51(2):241-7. doi: 10.1093/ajcn/51.2.241.

  • Muller MJ, Bosy-Westphal A, Klaus S, Kreymann G, Luhrmann PM, Neuhauser-Berthold M, Noack R, Pirke KM, Platte P, Selberg O, Steiniger J. World Health Organization equations have shortcomings for predicting resting energy expenditure in persons from a modern, affluent population: generation of a new reference standard from a retrospective analysis of a German database of resting energy expenditure. Am J Clin Nutr. 2004 Nov;80(5):1379-90. doi: 10.1093/ajcn/80.5.1379.

  • Nightingale TE, Gorgey AS. Predicting Basal Metabolic Rate in Men with Motor Complete Spinal Cord Injury. Med Sci Sports Exerc. 2018 Jun;50(6):1305-1312. doi: 10.1249/MSS.0000000000001548.

  • Owen OE, Holup JL, D'Alessio DA, Craig ES, Polansky M, Smalley KJ, Kavle EC, Bushman MC, Owen LR, Mozzoli MA, et al. A reappraisal of the caloric requirements of men. Am J Clin Nutr. 1987 Dec;46(6):875-85. doi: 10.1093/ajcn/46.6.875.

  • WEIR JB. New methods for calculating metabolic rate with special reference to protein metabolism. J Physiol. 1949 Aug;109(1-2):1-9. doi: 10.1113/jphysiol.1949.sp004363. No abstract available.

MeSH Terms

Conditions

Athletic Injuries

Interventions

Calorimetry, IndirectAnthropometry

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

CalorimetryChemistry Techniques, AnalyticalInvestigative TechniquesPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisBiometryEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Fernando Alacid Cárceles, PhD

    Universidad de Almeria

    PRINCIPAL INVESTIGATOR
  • Luis A Quiroga Morales, PhD

    Iberoamerican Institute of Sports Science and Human Movement

    PRINCIPAL INVESTIGATOR
  • Diego A Bonilla Ocampo, PhD

    DBSS International

    PRINCIPAL INVESTIGATOR
  • Adrian J Martínez Rubio, MSc

    Iberoamerican Institute of Sports Science and Human Movement

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research and Development

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 20, 2020

Study Start

June 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 20, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations