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.
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
- Conditions the study is for
- Resting Metabolic Rate, Disability Physical, Athletic Injuries
- 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
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.
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
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.
- First posted20 Jul 2020
- Study startJun 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Resting Metabolic RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Iberoamerican Institute of Sports Science and Human Movement
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cesar Octavio Ramos Garcia, PhD, Iberoamerican Institute of Sports Science and Human Movement
- Investigators
- Fernando Alacid Cárceles, PhD, Principal investigator, Universidad de AlmeriaLuis A Quiroga Morales, PhD, Principal investigator, Iberoamerican Institute of Sports Science and Human MovementDiego A Bonilla Ocampo, PhD, Principal investigator, DBSS InternationalAdrian J Martínez Rubio, MSc, Principal investigator, Iberoamerican Institute of Sports Science and Human Movement
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 28534498Cunningham 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 7435418Harris 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 16576330Henry 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 16277825Mifflin 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 2305711Muller 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 15531690Nightingale 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 29315167Owen 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 3687821WEIR 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Alternatives for the Estimation of the Resting Metabolic Rate From Anthropometric Variables in Paralympic Athletes
- ClinicalTrials.gov ID
- NCT04478565
- Acronym / sponsor ID
- RMRPA / IICDEM-ID-001-2020
- Keywords
- Anthropometry, Indirect Calorimetry, Bioenergetics, Metabolic rate, Paralympic Athletes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Iberoamerican Institute of Sports Science and Human MovementUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Mexican Paralympic swimmers from the national and the state adapted swimming team.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indirect CalorimetryAlso: AnthropometryRMR 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 | Other | – |
Primary outcome
Indirect Calorimetry
Time frame: One day
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.
Anthropometry
Time frame: One day
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Results publication: PubMed 28534498Chun 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.
- Results publication: PubMed 7435418Cunningham 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.
- Results publication: PubMed 16576330Harris 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.
- Results publication: PubMed 16277825Henry 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.
- Results publication: PubMed 2305711Mifflin 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.
- Results publication: PubMed 15531690Muller 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.
- Results publication: PubMed 29315167Nightingale 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.
- Results publication: PubMed 3687821Owen 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.
- Results publication: PubMed 15394301WEIR 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Alacid Cárceles, PhD principal investigator
Universidad de Almeria
Luis A Quiroga Morales, PhD principal investigator
Iberoamerican Institute of Sports Science and Human Movement
Diego A Bonilla Ocampo, PhD principal investigator
DBSS International
1 site in 1 country: see every site and its status.
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.