<?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>IRCT20221128056642N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-29</date_registration>
      <primary_sponsor>Razi university</primary_sponsor>
      <public_title>The Effect of L-Citrulline and Citrulline Malate Supplementation on Resistance Training Performance</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Acute and Chronic L-Citrulline and Citrulline Malate Supplementation on Resistance Training Performance, Muscle Soreness, Lactate and Nitric Oxide  in Resistance-Trained Men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67074</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Other, Other design features: Since this research plan aims to evaluate and compare both acute and chronic effects of supplementation with L-citrulline and citrulline malate, it consists of two separate phases. In the acute phase, in the form of a double-blind cross-over and counter-balanced placebo-controlled design, 30 resistance-trained male volunteers between the ages of 18 and 35 years will be examined for the acute effects of supplementation with L-citrulline and citrulline malate on resistance exercise performance and blood factors. In the chronic phase, in the form of a randomized, double-blind, placebo-controlled design, 45 resistance-trained male volunteers between the ages of 18 and 35 will be randomly divided into three groups of 15 each (Group 1: L-citrulline, Group 2: Citrulline malate and Group 3: Placebo) and will perform a resistance training protocol for eight weeks in addition to receiving the corresponding supplement, Randomization description: For the acute phase, due to the inclusion of three conditions (L-Citrulline, Citrulline malate, and Placebo), there were six possible sequences in which participants could complete the study (i.e. ABC, ACB, BAC, BCA, CAB and CBA). Based on the sample size (n = 30), each sequence will be used exactly five times. The order in which the sequences is assigned to participants will be determined using Random Sequence Generator at  WWW.RANDOM.ORG website. 
For the chronic phase, according to the existence of three groups (L-citrulline, citrulline malate, and placebo), all subjects (n=45) will be divided into three equal groups (15 subjects in each group) using a table of random numbers and will be placed in one of the groups in a simple random way, Blinding description: In the acute phase, the main researchers and all the people involved in data collection will be blinded to the type of intervention (supplement) given to each subject in each of the three main research sessions. To achieve this, the random assignment of the subjects in the counter-balance table and the preparation of the supplements provided to the subjects in each session are done by a research assistant who will not be present at the time of taking the supplement intervention at the research site and will not be involved in any part of the data collection process. Also, in order to keep the subjects blind, the supplement consumed by each subject in each research session is prepared by one of the research assistants and given to the subject to consume in a dark colored shaker whose contents are not known. In addition, the subject should also use a nose clip while drinking this mixture.
Similar to the acute phase, in the chronic phase, the main researchers and all the people involved in data collection are unaware of the type of intervention received by each subject during the eight weeks of exercise and supplementation protocol. To achieve this, random assignment of subjects to three groups is done by a research assistant who does not interfere in other stages of this research plan. Also, the supplement consumed by the subjects of all three groups is also prepared by the same research assistant. The supplement provided to the subjects of all three groups will be similar in terms of smell and taste.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Resistance training performance.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: supplementation with L-citrulline (8 grams of L-citrulline + 15 grams of maltodextrin) 60 minutes before the start of each main research session (resistance training)-In the acute phase, a single dose session and in the chronic phase, daily for eight weeks. Intervention 2: The second intervention group: supplementation with citrulline malate (12 grams of citrulline malate + 15 grams of maltodextrin) 60 minutes before the start of each main research session (resistance training); in the acute phase, a single dose session and in the chronic phase, daily for eight weeks. Intervention 3: Control group: The third group: supplementation with a placebo (15 grams of maltodextrin) 60 minutes before the start of each main research session (resistance exercise); in the acute phase, a single dose session and in the chronic phase, daily for eight 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>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 According to the advisors' opinion, a decision will be made at the end of the project.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Davoud Bayat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO. 142, 114 alley, 17 Shahrivar square</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714656458</zip>
        <telephone>+98 83 3838 6074</telephone>
        <email>d.bayat@razi.ac.ir</email>
        <affiliation>Razi university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Azizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi university, Bagh-e-Abrisham, Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3428 3267</telephone>
        <email>azizimihammad@gmail.com</email>
        <affiliation>Razi university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy men living in Kermanshah with an age range between 18 and 35 years
History of resistance training at least 3 sessions per week in the last six months
Body mass index 18.5 to 29.99 (kg/m2)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Smoking
Current or past use of anabolic androgenic steroids
Consuming performance-enhancing supplements affecting the research results (including creatine, HMB, beta-alanine and NO stimulants) in the four weeks leading up to the start of the research, or taking L-citrulline or citrulline malate supplements in the past year
Suffering from musculoskeletal injuries affecting the process of performing resistance training exercises
Having any acute or chronic disease</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 L-citrulline (8 grams of L-citrulline + 15 grams of maltodextrin) 60 minutes before the start of each main research session (resistance training)-In the acute phase, a single dose session and in the chronic phase, daily for eight weeks</i_keyword>
      <i_keyword>The second intervention group: supplementation with citrulline malate (12 grams of citrulline malate + 15 grams of maltodextrin) 60 minutes before the start of each main research session (resistance training); in the acute phase, a single dose session and in the chronic phase, daily for eight weeks</i_keyword>
      <i_keyword>Control group: The third group: supplementation with a placebo (15 grams of maltodextrin) 60 minutes before the start of each main research session (resistance exercise); in the acute phase, a single dose session and in the chronic phase, daily for eight weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resistance training performance. Timepoint: Acute phase: three acute research sessions with an interval of one week from each other. Chronic phase: one research session before and one session at the end of the eight-week protocol. Method of measurement: Recording the number of repetitions performed in each set of resistance training - recording the rate of perceived exertion using the Borg scale - measuring muscle soreness using a Visual Analog Scale (VAS) questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood factors (Lactate and Nitric Oxide). Timepoint: Acute phase: three acute research sessions with an interval of one week from each other. Chronic phase: one research session before and one session at the end of the eight-week protocol. Method of measurement: Blood sampling 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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-26</approval_date>
        <contact_name>Research ethics committees of Razi University</contact_name>
        <contact_address>No. 142, 114 Alley, 17 Shahrivar Square, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
