<?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>IRCT2016092129895N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-13</date_registration>
      <primary_sponsor>Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>The effect of glutamine supplementation on serum levels of Adiponectine and TNFα after exhaustive exercise in young males</public_title>
      <acronym></acronym>
      <scientific_title>The effect of glutamine supplementation on serum levels of Adiponectine and TNFα after exhaustive exercise in young males</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23914</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Young healthy males.</hc_freetext>
      <i_freetext>Intervention 1: Given 0.3 gr Glutamine in per Kgr weight of body with 25 gr sweat and 250 cc water for 14 days and once exhaustive exercise for intervention group. Intervention 2: Given 25 gr sweat and 250 cc water  for 14 days and once exhaustive exercise for control 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Mollazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Biochemistry Dept, Ardabil University of Medical Sciences, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran.</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5155653466</zip>
        <telephone>+98 45 1383 1568</telephone>
        <email>le.mollazadeh@arums.ac.ir</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Nemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutritional Biochemistry Dept., Faculty of Medicine, Ardabil University of Medical Sciences, Daneshg</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5618953141</zip>
        <telephone>+98 45 1551 2788</telephone>
        <email>ali.nemati@arums.ac.ir</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Young healthy males with moderate physical activity in 18-30 years old. Exclusion criteria: Individuals with any diseases; smoking; alcoholism and other supplements consumption; having certain dietary; professional training; sedentary and having BMI over 25 and less than18.5 kg.m2</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z02.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Examination for participation in sport</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Given 0.3 gr Glutamine in per Kgr weight of body with 25 gr sweat and 250 cc water for 14 days and once exhaustive exercise for intervention group</i_keyword>
      <i_keyword>Given 25 gr sweat and 250 cc water  for 14 days and once exhaustive exercise for control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Exhaustive exercise time. Timepoint: At the end of exercise. Method of measurement: With signs and symptoms of exhaustion.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Total cholesterol. Timepoint: At the beginning of intervention, previous of exercise. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: At the beginning of intervention, previous of exercise. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>HDL-cholesterol. Timepoint: At the beginning of intervention, previous of exercise. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>HsCRP. Timepoint: At the beginning of intervention, previous and after of exercise. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Adiponectin. Timepoint: At the beginning of intervention, previous and after of exercise. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Height. Timepoint: At the beginning of intervention. Method of measurement: Stadiometers.</sec_outcome>
      <sec_outcome>Malondialdehyde. Timepoint: At the beginning of intervention, previous and after of exercise. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Weight. Timepoint: At the beginning of intervention. Method of measurement: Digital scales.</sec_outcome>
      <sec_outcome>Total antioxidant capacity. Timepoint: At the beginning of intervention, previous and after of exercise. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Tumor necrosis factor-alpha. Timepoint: At the beginning of intervention, previous and after of exercise. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>LDL-cholesterol. Timepoint: At the beginning of intervention, previous of exercise. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Matrix metalloproteinase-2. Timepoint: At the beginning of intervention, previous and after of exercise. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Matrix metalloproteinase-9. Timepoint: At the beginning of intervention, previous and after of exercise. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Interlukine-6. Timepoint: At the beginning of intervention, previous and after of exercise. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Leptin. Timepoint: At the beginning of intervention, previous and after of exercise. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Oxidated LDL. Timepoint: At the beginning of intervention, previous and after of exercise. Method of measurement: ELISA.</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>Ardabil University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-02-09</approval_date>
        <contact_name>Ethic Committee of Ardabil University of Medical Sciences</contact_name>
        <contact_address>Ethic Committee of Ardabil University of Medical Sciences, Vice Chancellor for Research, Ardabil University of Medical Sciences, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran Ardabil  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
