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Resting Metabolic RateRMRPANCT04478565

Development of Alternatives for the Estimation of the Resting Metabolic Rate From Anthropometry in Paralympic Athletes

An observational study of Resting Metabolic Rate and Disability Physical, run by Iberoamerican Institute of Sports Science and Human Movement at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 59 yearsHealthy volunteers can take part
What is being tested?
Indirect Calorimetry
How many people
15 participants
Where
1 siteMexico
Study dates
Jun 2016to Jun 2016
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 10 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Iberoamerican Institute of Sports Science and Human Movement

    Zapopan, Jalisco, 45128

Other trials in Mexico

About this study

Official title: Development of Alternatives for the Estimation of the Resting Metabolic Rate From Anthropometric Variables in Paralympic Athletes

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.

Being tested
Indirect Calorimetry
Keywords
Anthropometry, Indirect Calorimetry, Bioenergetics, Metabolic rate, Paralympic Athletes
Medical subject headings
Athletic Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indirect CalorimetryOther

    Also called Anthropometry

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: One day

  2. 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).

    Measured: One day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2020
  2. Study startJun 2016
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04478565
Sponsor's protocol ID
IICDEM-ID-001-2020
Acronym
RMRPA
Status last verified
Jul 2020
First submitted
16 Jul 2020
Last updated
20 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28534498

  • 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.

    PubMed 7435418

  • 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.

    PubMed 16576330

  • 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.

    PubMed 16277825

  • 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.

    PubMed 2305711

  • 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.

    PubMed 15531690

  • 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.

    PubMed 29315167

  • 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.

    PubMed 3687821

  • 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.

    PubMed 15394301

Questions about this trial

What is this clinical trial studying?

An observational study of Resting Metabolic Rate and Disability Physical, run by Iberoamerican Institute of Sports Science and Human Movement at 1 site in Mexico.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Indirect Calorimetry (time frame: One day). The study lists 2 primary outcomes in all. 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 NCT04478565, which also lists 9 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 20 Jul 2020.

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