<?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>IRCT20221122056581N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-05</date_registration>
      <primary_sponsor>Razi University of Kermanshah</primary_sponsor>
      <public_title>The effect of supplementation with citrulline malate on resistance training performance</public_title>
      <acronym></acronym>
      <scientific_title>Acute effect of Citrulline malate oral Supplementation on upper-body resistance performance, blood pressure and post exercise hypotension in resistance trained men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67035</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Basic scienece, Other design features: Since this research project aims to evaluate and compare the acute effect of supplementing two different doses of citrulline malate, considering the existence of three groups (citrulline malate dose 8, citrulline malate dose 12, and placebo), all subjects (n=12) using a table of random numbers, they will be divided into three equal groups (4 people in each group) and they will be placed in one of the groups in a simple random manner, and for three weeks, three acute research sessions with an interval of one week from each other, along with Receiving the relevant supplement will implement a resistance training protocol, Randomization description: Due to the existence of three groups (citrulline malate dose 8, citrulline malate dose 12, and placebo), all the subjects (n=12) were divided into three equal groups (4 people in each group) using a random number table and randomly Simple will be placed in one of the groups. There are 3 possible sequences in which the participants can complete the study. That is (ABC, BCA, CAB) and based on the sample size (n=12), each sequence will be used exactly twice. The order of assigning the sequences to Participants will be determined using the Random Sequence Generator at WWW.RANDOM.ORG, Blinding description: Because the study was double-blind, the study subjects and the researchers did not know who would take citrulline malate or a placebo, and someone else would check the results. Also, in order not to distinguish the drug and the placebo, they will be prepared in the same glasses and the placebo group will use dextrose.</study_design>
      <phase>3</phase>
      <hc_freetext>Resistance exercise performance.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: supplementation with citrulline malate (8 grams) 60 minutes before the start of each main research session (resistance exercise) - in the acute phase of a single dose session. Intervention 2: The second intervention group: supplementation with citrulline malate (12 grams of citrulline malate) 60 minutes before the start of each main research session (resistance exercise) in the acute phase of one session and single dose. Intervention 3: Control group: third group: supplementation with placebo (10 grams of dextrose) 60 minutes before the start of each main research session (resistance exercise) - in the acute phase of a single dose session.</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 further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasser Behpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi University,University street,Taq Bostan</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3427 7605</telephone>
        <email>n_behpoor@yahoo.com</email>
        <affiliation>Razi University of Kermanshah</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasser Behpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi University,University street,Taq Bostan</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3427 7605</telephone>
        <email>n_behpoor@yahoo.com</email>
        <affiliation>Razi University of Kermanshah</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Athletes should be boys from the gym
2. The place of residence in the city of Ravansar
3. Age range from 21 to 39 years
4. Body mass index between 18.5 and 29.99
5. Having general health to participate in sports activities with the doctor's approval
6. Regular resistance sports activity program in 6 months before the beginning of the research</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>39 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>1.Having any chronic disease
2. History of allergy and sensitivity
3. Taking any sports supplement in two months before the start of the research
4. Smoking and alcohol consumption
5. No history of high blood pressure and neurological diseases
6. History of participation in any research related to supplement consumption and resistance exercises before starting the research</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: supplementation with citrulline malate (8 grams) 60 minutes before the start of each main research session (resistance exercise) - in the acute phase of a single dose session</i_keyword>
      <i_keyword>The second intervention group: supplementation with citrulline malate (12 grams of citrulline malate) 60 minutes before the start of each main research session (resistance exercise) in the acute phase of one session and single dose</i_keyword>
      <i_keyword>Control group: third group: supplementation with placebo (10 grams of dextrose) 60 minutes before the start of each main research session (resistance exercise) - in the acute phase of a single dose session</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resistance sports performance. Timepoint: Three acute research sessions, one week apart. Method of measurement: Record the number of repetitions performed in each set of resistance exercise.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure and heart rate. Timepoint: Three acute research sessions, one week apart. Method of measurement: Taking blood pressure and heart rate from each subject before and after each main research session.</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 of Kermanshah</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-04</approval_date>
        <contact_name>Ethics Committee of Razi University of Kermanshah</contact_name>
        <contact_address>Razi University, University Street,Taq Bostan Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
