<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04478565</url>
  </required_header>
  <id_info>
    <org_study_id>IICDEM-ID-001-2020</org_study_id>
    <nct_id>NCT04478565</nct_id>
  </id_info>
  <brief_title>Development of Alternatives for the Estimation of the Resting Metabolic Rate From Anthropometry in Paralympic Athletes</brief_title>
  <acronym>RMRPA</acronym>
  <official_title>Development of Alternatives for the Estimation of the Resting Metabolic Rate From Anthropometric Variables in Paralympic Athletes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Iberoamerican Institute of Sports Science and Human Movement</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Iberoamerican Institute of Sports Science and Human Movement</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To our knowledge no study has evaluated neither feasible methods for the assessment of&#xD;
      anthropometric profile nor indirect methods to estimate energy expenditure (EE) for adapted&#xD;
      athletes. The primary aim is to develop and validate new RMR prediction models, for the&#xD;
      estimation of the resting metabolic rate from anthropometric variables in young Mexican&#xD;
      Paralympic athletes; our second objective is to evaluate the agreement between RMR and the&#xD;
      prediction models of Cunningham, Harris-Benedict, Henry, Valencia, Chun, Nightingale &amp;&#xD;
      Gorgey, FAO/WHO, Mifflin, Müller, Owen, and our own models. A comparative cross-sectional&#xD;
      quantitative study was designed. Participants report to the testing laboratory only once for&#xD;
      data collection. The Strengthening the Reporting of Observational Studies in Epidemiology&#xD;
      criteria guidelines for cross-sectional research (STROBE) is followed in the design/reporting&#xD;
      of this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Indirect Calorimetry</measure>
    <time_frame>One day</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anthropometry</measure>
    <time_frame>One day</time_frame>
    <description>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).</description>
  </primary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>Resting Metabolic Rate</condition>
  <condition>Disability Physical</condition>
  <condition>Athletic Injuries</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Indirect Calorimetry</intervention_name>
    <description>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.&#xD;
The anthropometric measurements were performed by certified level 3 anthropometrists following the guidelines of the International Society for the Advancement of Kinanthropometry, ISAK</description>
    <other_name>Anthropometry</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Mexican Paralympic swimmers from the national and the state adapted swimming team.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        i) swimmers who report to the assessment area with a fasting period of 6 to 8 hours, and at&#xD;
        least 12 hours after their last exercise routine; ii) swimmers who have not consumed&#xD;
        alcohol or any stimulant for the last 48 hours (e.g., coffee, tea, chocolate, carbonated&#xD;
        drinks, energy drinks, supplements); iii) swimmers who has contested at least in one of the&#xD;
        last two swimming competitions, including World Championships and Paralympic Games&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        i) fail to complete the indirect calorimetry test after two attempts; ii) attend to the&#xD;
        evaluation area without the appropriate clothing or without following the instructions for&#xD;
        fasting, exercise, and feeding prior to the evaluations; iii) swimmers who at the time of&#xD;
        the evaluations did not give written consent (parental consent in case of under 18 years&#xD;
        old) for procedures or data release for research purposes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernando Alacid Cárceles, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Almeria</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luis A Quiroga Morales, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Iberoamerican Institute of Sports Science and Human Movement</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Diego A Bonilla Ocampo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>DBSS International</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Adrian J Martínez Rubio, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Iberoamerican Institute of Sports Science and Human Movement</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Iberoamerican Institute of Sports Science and Human Movement</name>
      <address>
        <city>Zapopan</city>
        <state>Jalisco</state>
        <zip>45128</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>28534498</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>7435418</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>16576330</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>16277825</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>2305711</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>15531690</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>29315167</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>3687821</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>15394301</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Iberoamerican Institute of Sports Science and Human Movement</investigator_affiliation>
    <investigator_full_name>Cesar Octavio Ramos Garcia, PhD</investigator_full_name>
    <investigator_title>Head of Research and Development</investigator_title>
  </responsible_party>
  <keyword>Anthropometry</keyword>
  <keyword>Indirect Calorimetry</keyword>
  <keyword>Bioenergetics</keyword>
  <keyword>Metabolic rate</keyword>
  <keyword>Paralympic Athletes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Athletic Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04478565
org study id: IICDEM-ID-001-2020
nct id: NCT04478565
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Other
time perspective: Cross-Sectional
measure: Indirect Calorimetry
time frame: One day
description: 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.
measure: Anthropometry
time frame: One day
description: 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).
intervention type: Other
intervention name: Indirect Calorimetry
description: 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
other name: Anthropometry
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fernando Alacid Cárceles, PhD
role: Principal Investigator
affiliation: Universidad de Almeria
last name: Luis A Quiroga Morales, PhD
role: Principal Investigator
affiliation: Iberoamerican Institute of Sports Science and Human Movement
last name: Diego A Bonilla Ocampo, PhD
role: Principal Investigator
affiliation: DBSS International
last name: Adrian J Martínez Rubio, MSc
role: Principal Investigator
affiliation: Iberoamerican Institute of Sports Science and Human Movement
facility: 
country: Mexico
citation: 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.
PMID: 28534498
citation: 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.
PMID: 7435418
citation: 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.
PMID: 16576330
citation: 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.
PMID: 16277825
citation: 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.
PMID: 2305711
citation: 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.
PMID: 15531690
citation: 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.
PMID: 29315167
citation: 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.
PMID: 3687821
citation: 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.
PMID: 15394301
responsible party type: Principal Investigator
investigator affiliation: Iberoamerican Institute of Sports Science and Human Movement
investigator full name: Cesar Octavio Ramos Garcia, PhD
investigator title: Head of Research and Development
mesh term: Athletic Injuries
sharing ipd: No