<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20220417054556N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-27</date_registration>
      <primary_sponsor>Razi University</primary_sponsor>
      <public_title>The effect of transcranial direct current stimulation and dark chocolate on cyclists' athletic and cognitive performance</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of the effects of transcranial direct current stimulation and dark chocolate supplementation on athletic and cognitive performance in normobaric hypoxia after inducing mental fatigue in men cyclists</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63130</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: In order to randomize the order of subjects' exposure to four different conditions, the Latin square method will be used. To do this, first using the site www.random.org, each subject will be randomly assigned a number between 1 and 12 as the identification code. Then, the English letters A, B, C, and D are assigned to the four intervention terms, and a Latin square with four rows and four columns is created. After creating the Latin square, participants 1 to 3 in the first row sequence, participants 4 to 6 in the second row sequence, participants 7 to 9 in the third row sequence, and participants 10 to 12 in the sequence Sequences will be placed in the fourth row, Blinding description: The subjects and the researcher will not be aware of the type of stimulation received in each session and this information will be available only to someone outside the research team until the end of the research. In order to conceal the order of receiving the stimulus from the researcher, all the steps related to randomly determining the order of receiving the stimulus in each subject will be performed by the same person outside the research team. Also, in order to hide the type of stimulation in each session of the subjects, the tDCS device is hidden from the subjects by a cover and the researcher will not be present in the laboratory during the installation of the electrodes and at the end of 20 minutes and the time of electrode separation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Hypoxia. Condition 2: mental fatigue.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group: 2: sham stimulation-dark chocolate, 1: anodal stimulation-dark chocolate." . In both groups of stimulation, after installing the electrodes, the subjects will receive anodal and sham electrical stimulation with a intensity of 2 mA crosswise in a sitting position and one session per week (for 4 weeks) for 20 minutes. Chocolate supplement Bitter (467 kcal of dark chocolate (Nestle-70%)  will also be received cross-over each week for four weeks. Intervention 2: "Control group: 1:Anodal stimulation- White chocolate, 2:Sham stimulation-White chocolate." In both groups of stimulation, after installing the electrodes, the subjects will receive anodal and sham electrical stimulation with a intensity of 2 mA crosswise in a sitting position and one session per week (for 4 weeks) for 20 minutes. They will also receive white chocolate supplements ((487 kcal from Nestle white chocolate)) cross-over each week for four weeks.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa Banaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi University., Faculty of Sports Sciences., University Blvd., Taq Bostan,</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3427 7605</telephone>
        <email>p.banayi@yahoo.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vahid Tadibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi University., Faculty of Sports Sciences., University Blvd., Taq Bostan</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3427 7605</telephone>
        <email>vtadibi@yahoo.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Active cyclist under the supervision of Kermanshah city cycling board
Regular cycling practice for the past six months at least three times a week
Obtaining a certificate of non-prohibition from participating in an exercise program from a physician
Being right-handed
Age range 18 to 44 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>44 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group: 2: sham stimulation-dark chocolate, 1: anodal stimulation-dark chocolate." . In both groups of stimulation, after installing the electrodes, the subjects will receive anodal and sham electrical stimulation with a intensity of 2 mA crosswise in a sitting position and one session per week (for 4 weeks) for 20 minutes. Chocolate supplement Bitter (467 kcal of dark chocolate (Nestle-70%)  will also be received cross-over each week for four weeks.</i_keyword>
      <i_keyword>"Control group: 1:Anodal stimulation- White chocolate, 2:Sham stimulation-White chocolate." In both groups of stimulation, after installing the electrodes, the subjects will receive anodal and sham electrical stimulation with a intensity of 2 mA crosswise in a sitting position and one session per week (for 4 weeks) for 20 minutes. They will also receive white chocolate supplements ((487 kcal from Nestle white chocolate)) cross-over each week for four weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Endurance sports performance. Timepoint: Before starting the intervention  and every 3 minutes from the beginning of the test  to exhaustion in each session for 4 weeks. Method of measurement: The Astrand test for men is used to measure the maximum power output of the subjects.</prim_outcome>
      <prim_outcome>Cognitive function. Timepoint: Before starting the intervention  and every 3 minutes from the beginning of the test  to exhaustion in each session for 4 weeks. Method of measurement: A reaction time test is used.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Razi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-16</approval_date>
        <contact_name>Ethics committee of Razi University</contact_name>
        <contact_address>Razi University, Tagh-e-Bostan, University St. kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
