<?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>IRCT20230131057292N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-03</date_registration>
      <primary_sponsor>University of Tehran</primary_sponsor>
      <public_title>Comparison of the Effects of Different Caffeine Consumption Methods on Game-Induced Fatigue in Small-Sided Games in Young Professional Male Football Players</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of different caffeine administration methods (capsule, gum, and mouth rinse) on fatigue induced by small-sided games in young professional male football players: A randomized, double-blind, crossover study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>16</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/92876</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Other, Other design features: Randomized, double-blind, crossover study. All participants receive all interventions (capsule, gum, mouthrinse, and placebo) with an appropriate washout period between sessions, Randomization description: The sequence of interventions (caffeine capsule, caffeine gum, caffeine mouth rinse, and their respective placebos) for each participant was determined using a simple lottery/drawing method. Different sequences were written on identical cards and placed in sequentially numbered, opaque, sealed envelopes. An envelope was drawn for each football player to determine the sequence of conditions across the crossover trials, thereby controlling for potential order and carryover effects, Blinding description: Caffeine and matching placebo formulations (capsules, gums, and mouth rinses) are prepared to be identical in appearance, color, smell, taste, and packaging. The interventions are coded and packaged by an independent third party not involved in data collection. Both the participants (football players) and outcome assessors remain blinded to the intervention assignments until the completion of testing and statistical analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Small-sided game-induced fatigue in young professional male football players.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 400 mg caffeine capsule consumed 30 minutes before the start of warm-up. Intervention 2: Intervention group: Two caffeinated chewing gums containing 200 mg each (400 mg total), chewed for 5 minutes, starting 5 minutes before warm-up. Intervention 3: Intervention group: 750 mg caffeine mouth rinse for 15 seconds immediately before the first set and during the recovery periods between sets, followed by expectoration. Intervention 4: Control group: Placebo consists of a caffeine-free cellulose capsule, caffeine-free chewing gum with a similar flavor, and caffeine-free mouth rinse with a similar taste, administered according to the timing of the corresponding caffeine conditions.</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 To protect participants’ confidentiality and privacy, there is no plan to publicly share individual participant data. Study results will be reported only in aggregate form without identifying information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shima Mojtahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faulty of Sport Sciences and Health, 15th Ave, North Kargar st, Tehran, IRNN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439813117</zip>
        <telephone>+98 21 6111 8872</telephone>
        <email>shmojtahedi@ut.ac.ir</email>
        <affiliation>The University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shima Mojtahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehran, Islamic Republic</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439813117</zip>
        <telephone>+98 21 6111 8872</telephone>
        <email>shmojtahedi@ut.ac.ir</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having at least 3 years of playing experience in national football leagues
No history of musculoskeletal injuries in the past 6 months
Refraining from using ergogenic supplements (such as creatine, beta-alanine, caffeine, etc.) for at least 48 hours before each test session
No consumption of tobacco products and psychoactive substances within 72 hours before the start of the study protocols
Commitment to recording and replicating the exact 24-hour dietary intake before the first test session for all subsequent sessions</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>18 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Occurrence of any new injury during the study that prevents continuing the protocol
History of caffeine allergy/sensitivity in medical records or observation of any adverse side effects during the trial
Unwillingness of the participant to continue cooperation at any stage of the study</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>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 400 mg caffeine capsule consumed 30 minutes before the start of warm-up</i_keyword>
      <i_keyword>Intervention group: Two caffeinated chewing gums containing 200 mg each (400 mg total), chewed for 5 minutes, starting 5 minutes before warm-up</i_keyword>
      <i_keyword>Intervention group: 750 mg caffeine mouth rinse for 15 seconds immediately before the first set and during the recovery periods between sets, followed by expectoration</i_keyword>
      <i_keyword>Control group: Placebo consists of a caffeine-free cellulose capsule, caffeine-free chewing gum with a similar flavor, and caffeine-free mouth rinse with a similar taste, administered according to the timing of the corresponding caffeine conditions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue index measured by the RAST following the small-sided game protocol. Timepoint: After the small-sided game protocol in each of the four experimental sessions. Method of measurement: Using the RAST consisting of six maximal 35-m sprints with 10 s recovery between sprints.</prim_outcome>
      <prim_outcome>Peak power assessed by RAST after the small-sided game. Timepoint: After the small-sided game protocol in each experimental session. Method of measurement: Assessed using RAST consisting of six maximal 35-m sprints.</prim_outcome>
      <prim_outcome>Mean power assessed by RAST after the small-sided game. Timepoint: After the small-sided game protocol in each experimental session. Method of measurement: Assessed using RAST consisting of six maximal 35-m sprints.</prim_outcome>
      <prim_outcome>Passing performance and accuracy after the small-sided game. Timepoint: After the small-sided game protocol in each experimental session. Method of measurement: Using the McDonald Soccer Skill Test, the number of successful passes during a 30-s trial is recorded.</prim_outcome>
      <prim_outcome>Countermovement jump (CMJ) performance after the small-sided game. Timepoint: After questionnaire completion, following the small-sided game in each session. Method of measurement: Using the CMJ test and the My Jump 2 application, with hands placed on the hips.</prim_outcome>
      <prim_outcome>Squat jump (SJ) performance after the small-sided game. Timepoint: After questionnaire completion, following the small-sided game in each session. Method of measurement: SJ performed from a 90° knee-flexion position with hands on the hips.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Rating of perceived exertion (RPE) after the small-sided game. Timepoint: Five minutes after the fifth set in each session. Method of measurement: 15-point Borg scale ranging from 6 to 20.</sec_outcome>
      <sec_outcome>Exercise enjoyment (EES) after the small-sided game. Timepoint: Five minutes after the fifth set in each session. Method of measurement: Exercise Enjoyment Scale with 8 items rated on a 7-point Likert scale.</sec_outcome>
      <sec_outcome>Mental fatigue (MF) after the small-sided game. Timepoint: Five minutes after the fifth set in each session. Method of measurement: Visual Analogue Scale (VAS) from 0=no fatigue to 10=severe fatigue.</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 Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-08-25</approval_date>
        <contact_name>Research Ethics Committee of the Faculty of Physical Education and Sport Sciences, University of Teh</contact_name>
        <contact_address>Tehran - North Kargar St. - Above Jalal Al-e Ahmad Intersection - Between 15th and 16th Streets - Opposite University of Tehran Dormitory (Koye Daneshgah) Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
