<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/NCT04427319</url>
  </required_header>
  <id_info>
    <org_study_id>UCAMCFE-00014</org_study_id>
    <nct_id>NCT04427319</nct_id>
  </id_info>
  <brief_title>The Efficacy β-Alanine Supplementation in Performance Outcomes of Road Professional Endurance Cyclists</brief_title>
  <acronym>ELITE</acronym>
  <official_title>A Randomised Double-blind Clinical Trial to Analyse the Efficacy of Short-term β-Alanine Supplementation in Performance Outcomes of Road Professional Endurance Cyclists</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Católica San Antonio de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Católica San Antonio de Murcia</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A double-blind, placebo-controlled, randomised, with two arms (product and placebo)&#xD;
      unicentric clinical trial to analyse the efficacy on physical performance parameters of a&#xD;
      product designed for sport during a lapse of two weeks (7 days).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After recruitment, subject will be randomised and allocated to one group of the 2 study arms:&#xD;
      treatment group or control group (placebo).&#xD;
&#xD;
      A simple randomisation will be performed using software by a random number generator, and&#xD;
      assigned to participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2020</start_date>
  <completion_date type="Actual">June 12, 2020</completion_date>
  <primary_completion_date type="Actual">March 6, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Change of baseline rate of perceived exertion at seven days</time_frame>
    <description>Rate of perceived exertion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performance outcomes</measure>
    <time_frame>It will be measured on two different occasions. Day one and seven days later.</time_frame>
    <description>Physical performance is measured by direct variables: mean power output (MPO) and peak power output by ergometer (Cyclus 2) together with cadence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paresthesia test</measure>
    <time_frame>It will be measured on three different occasions. Twice on day 1 (before and after consumption) and seven days after.</time_frame>
    <description>Visual analogue scale (1-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microcapillary blood</measure>
    <time_frame>It will be measured on two different occasions. Day one and seven days later.</time_frame>
    <description>This test provides biochemical variables (ABL90FLEX).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Supplementation</condition>
  <condition>Cyclists</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Product: β-Alanine Supplementation strategy: 5 g, four times a day with main meals, for 7 days after the initial evaluation and until the end of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Product: wheat semolina Supplementation strategy: 5 g, four times a day with main meals, for 7 days after the initial evaluation and until the end of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>β-alanine</intervention_name>
    <description>7 days of consumption</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>wheat semolina</intervention_name>
    <description>7 days of consumption</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Not respecting rest the day before physical tests.&#xD;
&#xD;
          -  Not being in a fasted state (at least 2 h from last meal).&#xD;
&#xD;
          -  Having consumed stimulants acutely before the trial, or under drug treatment affecting&#xD;
             perceived effort of the trial.&#xD;
&#xD;
          -  Not being available to perform every trial on the same conditions at the same time of&#xD;
             the day.&#xD;
&#xD;
          -  Not sticking to the same diet, 24 h before each trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adverse event&#xD;
&#xD;
          -  Protocol violation&#xD;
&#xD;
          -  Lost to follow-up&#xD;
&#xD;
          -  Allergy to any of the components of the treatment or placebo product. This includes&#xD;
             allergy to β-alanine, wheat, soy, nuts (including peanuts), sesame and its byproducts.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Catholic University of Murcia</name>
      <address>
        <city>Murcia</city>
        <zip>30107</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Católica San Antonio de Murcia</investigator_affiliation>
    <investigator_full_name>Francisco Javier López Román</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT04427319
org study id: UCAMCFE-00014
nct id: NCT04427319
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A double-blind, placebo-controlled, randomised, with two arms (product and placebo)
      unicentric clinical trial to analyse the efficacy on physical performance parameters of a
      product designed for sport during a lapse of two weeks (7 days).
After recruitment, subject will be randomised and allocated to one group of the 2 study arms:
      treatment group or control group (placebo).

      A simple randomisation will be performed using software by a random number generator, and
      assigned to participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Fatigue
time frame: Change of baseline rate of perceived exertion at seven days
description: Rate of perceived exertion
measure: Performance outcomes
time frame: It will be measured on two different occasions. Day one and seven days later.
description: Physical performance is measured by direct variables: mean power output (MPO) and peak power output by ergometer (Cyclus 2) together with cadence.
measure: Paresthesia test
time frame: It will be measured on three different occasions. Twice on day 1 (before and after consumption) and seven days after.
description: Visual analogue scale (1-10)
measure: Microcapillary blood
time frame: It will be measured on two different occasions. Day one and seven days later.
description: This test provides biochemical variables (ABL90FLEX).
arm group label: Experimental group
arm group type: Experimental
description: Product: β-Alanine Supplementation strategy: 5 g, four times a day with main meals, for 7 days after the initial evaluation and until the end of the study.
arm group label: Placebo group
arm group type: Placebo Comparator
description: Product: wheat semolina Supplementation strategy: 5 g, four times a day with main meals, for 7 days after the initial evaluation and until the end of the study.
intervention type: Dietary Supplement
intervention name: β-alanine
description: 7 days of consumption
arm group label: Experimental group
intervention type: Dietary Supplement
intervention name: wheat semolina
description: 7 days of consumption
arm group label: Placebo group
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Católica San Antonio de Murcia
investigator full name: Francisco Javier López Román
investigator title: Principal Investigator
sharing ipd: No