<?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>IRCT20190923044853N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-08</date_registration>
      <primary_sponsor>Deputy Director of Research and Technology University of Mohaghegh Ardabili</primary_sponsor>
      <public_title>The effects of rapid weight loss on the cardiac cell damage</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of two types of acute weight loss program (2% and 4%) on the levels of creatine kinase and cardiac troponin enzymes in wrestlers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>16</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42380</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute weight loss.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group 1:"  Weight loss by 2%. After one week of weight control (pre-exercise, post-exercise and fasting), the subjects were present in the dry sauna to reduce their body weight by 2% of their initial weight. The test was conducted in a single day and up to 5 hours. These five hours consisted of at most ten 20-minute sessions until reaching the desired weight. Since the study was as cross-over, after two weeks rest, the same procedure was conducted for second group. Intervention 2: "Intervention group 2:" Weight loss by 4%. After one week of weight control (pre-exercise, post-exercise and fasting), the subjects were present in the dry sauna to reduce their body weight by 4% of their initial weight. The test was conducted in a single day and up to 5 hours. These five hours consisted of at most ten 20-minute sessions until reaching the desired weight. Since the study was as cross-over, after two weeks rest, the same procedure was conducted for second group.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is The subjects of this study are all athletes and are not patients.
We've spent a lot of time and money to collect this data, and we plan to use it in other scientific articles in the future. In order to prevent possible misuse, it is not possible for us to publish it until the relevant articles are published. Obviously the data will be released after the writing of the relevant articles.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Farzizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No, 179, University of Mohaghegh Ardabili, Daneshghah street, Ardabil</address>
        <city>Ardebil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5619911367</zip>
        <telephone>+98 45 3150 5643</telephone>
        <email>reza_farzizadeh@yahoo.com</email>
        <affiliation>University of Mohaghegh Ardabili</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Farzizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No, 179, University of Mohaghegh Ardabili, Daneshghah street, Ardabil</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5619911367</zip>
        <telephone>+98 45 3150 5643</telephone>
        <email>reza_farzizadeh@yahoo.com</email>
        <affiliation>University of Mohaghegh Ardabili</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Health and medical examinations
professional experience in wrestling with attending in competitions</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Ergogenic Supplements
Infectious diseases
surgical record
lack of complete physical health</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group 1:"  Weight loss by 2%. After one week of weight control (pre-exercise, post-exercise and fasting), the subjects were present in the dry sauna to reduce their body weight by 2% of their initial weight. The test was conducted in a single day and up to 5 hours. These five hours consisted of at most ten 20-minute sessions until reaching the desired weight. Since the study was as cross-over, after two weeks rest, the same procedure was conducted for second group.</i_keyword>
      <i_keyword>"Intervention group 2:" Weight loss by 4%. After one week of weight control (pre-exercise, post-exercise and fasting), the subjects were present in the dry sauna to reduce their body weight by 4% of their initial weight. The test was conducted in a single day and up to 5 hours. These five hours consisted of at most ten 20-minute sessions until reaching the desired weight. Since the study was as cross-over, after two weeks rest, the same procedure was conducted for second group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cardiac Troponin. Timepoint: At baseline (before weight loss), immediately after weight loss and 6 and 24 hours after weight loss. Method of measurement: Biochemical Auto analyzer Model BT3500 Made in Germany and Iranian Pars Azmoon Kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cardiac creatine kinase. Timepoint: At baseline (before weight loss), immediately after weight loss and 6 and 24 hours after weight loss. Method of measurement: Biochemical Auto analyzer Model BT3500 Made in Germany and Iranian Pars Azmoon Kit.</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>Deputy Director of Research and Technology University of Mohaghegh Ardabili</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-01</approval_date>
        <contact_name>Ethics Committee,  Research-Institute of Physical Education and Sport Sciences</contact_name>
        <contact_address>No. 3, 5th alley., Mir Emad street, Motahari avenue, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
