<?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>IRCT20190720044283N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-27</date_registration>
      <primary_sponsor>University of Guilan</primary_sponsor>
      <public_title>Caffeine Dose and Autonomic Recovery</public_title>
      <acronym></acronym>
      <scientific_title>Effect of caffeine dose on heart rate variability, rate pressure product and some fatigue indexes after endurance exercise in trained men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59493</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Crossover, Purpose: Other, Randomization description: Use the random selection method by Excel software.
In this method, we first enter the names of the subjects in Excel, and then in another part, we specify the position of the desired groups in two separate sections of 6 subjects. Then in these two sections, we will execute the following code so that people are randomly placed in groups of 6 subjects.
=INDEX($A$3:$A$12,RANDBETWEEN(1,ROWS($A$3:$A$12)),1), Blinding description: In this study, subjects were not aware of how caffeine or placebo was distributed. The determined amount of supplement and placebo was weighed for each subject separately and was delivered to the subjects by coding by the laboratory operator on each day of the test.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Recovery of indicators of the autonomic nervous system.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Dose of 6 mg/kg of caffeine and endurance activity. Intervention 2: Intervention group: Dose of 9 mg/kg of caffeine and endurance activity. Intervention 3: Control group: Taking placebo along with performing endurance activity.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
After analyzing the data, only part of the data related to the main outcome will be shared.

When:
After approval by the journal publishing the study report

To whom:
Journal publisher of study reports

Conditions:
By getting permission from the journal publish the study report

Where to obtain:
Journal publisher of study reports

How to obtain:
Public and private terms Journal of the study report

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Javad Mehrabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>8 km of Tehran road, Faculty of Physical Education and Sports Sciences, University of Guilan</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199843653</zip>
        <telephone>+98 911 230 9074</telephone>
        <email>mehrabanij@guilan.ac.ir</email>
        <affiliation>Faculty of Physical Education and Sports Sciences, University of Guilan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Javad Mehrabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>8 km of Tehran road, Faculty of Physical Education and Sports Sciences, University of Guilan</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199843653</zip>
        <telephone>+98 911 230 9074</telephone>
        <email>mehrabanij@guilan.ac.ir</email>
        <affiliation>Faculty of Physical Education and Sports Sciences, University of Guilan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Subjects have exercised regularly (three sessions per week or more) over the past two years
None of the subjects used supplements or ergogenic aids.
No use of anabolic steroids or central nervous system stimulants in the last two years
No caffeine intake of more than 300 mg per day
No history of cardiovascular and metabolic diseases
No history of alcohol and tobacco use
Optimal body composition and physical health</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>22 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Dose of 6 mg/kg of caffeine and endurance activity</i_keyword>
      <i_keyword>Intervention group: Dose of 9 mg/kg of caffeine and endurance activity</i_keyword>
      <i_keyword>Control group: Taking placebo along with performing endurance activity</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rate variability. Timepoint: 15 minutes after attending the laboratory (before breakfast), 35 minutes after supplementation, immediately and at 1, 2, 3, 5, 10, 20, 40, and 60 minutes after exercise. Method of measurement: Heart rate monitor (Polar-H10).</prim_outcome>
      <prim_outcome>Systolic and diastolic blood pressure. Timepoint: 15 minutes after attending the laboratory (before breakfast), 35 minutes after supplementation, immediately and at 1, 2, 3, 5, 10, 20, 40, and 60 minutes after exercise. Method of measurement: hand barometer (Zenith, ZTH-5001, Switzerland).</prim_outcome>
      <prim_outcome>Rate pressure product. Timepoint: At all points when heart rate and blood pressure will also be measured. Method of measurement: It is calculated by multiplying systolic blood pressure and heart rate.</prim_outcome>
      <prim_outcome>Rate of Perceived Exertion (RPE). Timepoint: Immediately after exercise. Method of measurement: Borg scale (6-20).</prim_outcome>
      <prim_outcome>Muscle Pain. Timepoint: Immediately after exercise until one hour after exercise. Method of measurement: Visual Analogue Scale (VAS).</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>University of Guilan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-15</approval_date>
        <contact_name>Research Ethics Committee of Sports Science Institute (SSRI)</contact_name>
        <contact_address>Fifth Alley, Mir Emad St., Ostad Motahhari St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
