<?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>IRCT20240521061865N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-17</date_registration>
      <primary_sponsor>The University of Guilan</primary_sponsor>
      <public_title>The short-term effect of caffeine supplement on changes in myocardial oxygen consumption, heart rate variability, Delayed-Onset Muscle Soreness (DOMS) and rating of perceived exertion in trained young men</public_title>
      <acronym></acronym>
      <scientific_title>The short-term effect of caffeine supplement on changes in myocardial oxygen consumption, heart rate variability, Delayed-Onset Muscle Soreness (DOMS) and rating of perceived exertion in trained young men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77087</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Blinding description: participants, contributors. Lack of knowledge about taking pills or placebo.</study_design>
      <phase>3</phase>
      <hc_freetext>Effects of caffeine supplementation on cardiac rhythm changes in trained and healthy young men with circuit resistance training.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 1They ingested caffeine Alhavi Enercaff 200 Capsules made in Iran  (4mg/kg) After 8 hours of fasting consumption, participants were monitored throughout a 30minutes ingested period, then complete resistance training with an intensity of 70-80% 1RM, followed by 30 minutes of recovery. Heart rate variability indexes (RMSSD and LF,HF, LF/HF) were taken with Elite HRV and Kubios Software at the baseline, 30 minutes after caffeine ingestion, recovery 1 (0-5 minutes), recovery 2 (5-10)recovery3(15-20 minutes), recovery 4(25-30)pressure product (RPP) were taken at the baseline, pre training and post training minutes after caffeine consumption, immediately after exercis30 minutes of recovery period , rating of perceived exertion (RPE)  immediately ,2min,3min,5min and10 minutes of recovery period with Borg scale delayed onset muscle soreness were taken though ROM test, MVC test from Thigh and knee extensor sergeant test and McGill questionnaire for72hours after RT. Intervention 2: Intervention group: 2Intervention group: 1They ingested placebo tablet Contains elderberry powder  (4mg/kg) After 8 hours of fasting consumption, participants were monitored throughout a 30minutes ingested period, then complete resistance training with an intensity of 70-80% 1RM, followed by 30 minutes of recovery. Heart rate variability indexes (RMSSD and LF,HF, LF/HF) were taken with Elite HRV and Kubios Software at the baseline, 30 minutes after caffeine ingestion, recovery 1 (0-5 minutes), recovery 2 (5-10)recovery3(15-20 minutes), recovery 4(25-30)pressure product (RPP) were taken at the baseline, pre training and post training minutes after caffeine consumption, immediately after exercis30 minutes of recovery period , rating of perceived exertion (RPE)  immediately ,2min,3min,5min and10 minutes of recovery period with Borg scale delayed onset muscle soreness were taken though ROM test, MVC test from Thigh and knee extensor sergeant test and McGill questionnaire for72hours after RT.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ronak latifnezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin-Rasht road</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613776</zip>
        <telephone>+98 13 3369 0274</telephone>
        <email>Ronak.latifnezhad@yahoo.com</email>
        <affiliation>The University ofGuilan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arsalan Damirchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin-Rasht road</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613776</zip>
        <telephone>+98 13 3369 0274</telephone>
        <email>damirchi@guilan.ac.ir</email>
        <affiliation>The University of Guilan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1) young trained men with at least 6 months of regular training with ahomogeneous age and weight range 2) no reduction and no medical prohibition in caffeine consumption and no medical prohibition to perform sports activities 3) no long-term history of caffeine consumption 4) physically healthy and no injuries and no special clinical considerations</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Observing excessive consumption of caffeine in the subject (insomnia, restlessness, behavioral changes, mobility and increased heart rate</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: 1They ingested caffeine Alhavi Enercaff 200 Capsules made in Iran  (4mg/kg) After 8 hours of fasting consumption, participants were monitored throughout a 30minutes ingested period, then complete resistance training with an intensity of 70-80% 1RM, followed by 30 minutes of recovery. Heart rate variability indexes (RMSSD and LF,HF, LF/HF) were taken with Elite HRV and Kubios Software at the baseline, 30 minutes after caffeine ingestion, recovery 1 (0-5 minutes), recovery 2 (5-10)recovery3(15-20 minutes), recovery 4(25-30)pressure product (RPP) were taken at the baseline, pre training and post training minutes after caffeine consumption, immediately after exercis30 minutes of recovery period , rating of perceived exertion (RPE)  immediately ,2min,3min,5min and10 minutes of recovery period with Borg scale delayed onset muscle soreness were taken though ROM test, MVC test from Thigh and knee extensor sergeant test and McGill questionnaire for72hours after RT.</i_keyword>
      <i_keyword>Intervention group: 2Intervention group: 1They ingested placebo tablet Contains elderberry powder  (4mg/kg) After 8 hours of fasting consumption, participants were monitored throughout a 30minutes ingested period, then complete resistance training with an intensity of 70-80% 1RM, followed by 30 minutes of recovery. Heart rate variability indexes (RMSSD and LF,HF, LF/HF) were taken with Elite HRV and Kubios Software at the baseline, 30 minutes after caffeine ingestion, recovery 1 (0-5 minutes), recovery 2 (5-10)recovery3(15-20 minutes), recovery 4(25-30)pressure product (RPP) were taken at the baseline, pre training and post training minutes after caffeine consumption, immediately after exercis30 minutes of recovery period , rating of perceived exertion (RPE)  immediately ,2min,3min,5min and10 minutes of recovery period with Borg scale delayed onset muscle soreness were taken though ROM test, MVC test from Thigh and knee extensor sergeant test and McGill questionnaire for72hours after RT.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rhythm song of healthy and trained young men. Timepoint: Variability of heart rate, blood pressure and perception of baseline and post-exercise pressure, delayed concussion up to 72 hours after exercise. Method of measurement: Cubius and Elite HRV software, sphygmomanometer, Borg scale, McGill questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>The University of Guilan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-18</approval_date>
        <contact_name>University of Guilan</contact_name>
        <contact_address>Qazvin-Rasht road Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
