<?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>IRCT20151228025732N76</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-10</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of twelve weeks of high-intensity functional training with Astaxanthin supplementation on some inflammatory markers in men with obesity</public_title>
      <acronym></acronym>
      <scientific_title>The effect of twelve weeks of high-intensity functional training with Astaxanthin supplementation on some inflammatory and antioxidant markers, adipokines, myokines, and hepatokines in men with obesity</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69049</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: We will construct 6 blocks in AABB, BBAA, ABAB, BABA, ABBA, and BAAB using four blocks. We will assign 1 to 6 for each block. Then, using the random number table, based on the sample size, 11 units of 4 blocks will be selected so that we consider having 11 people in the group (A), 11 people in the group (B), 11 people in the group (C) and 11 people in the group (D). Therefore, we will do block randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obesity and overweight.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: In this group, according to the protocol, they will perform a high-intensity functional training program (HIFT) in 36 sessions of 60 minutes, in which CrossFit is used. Daily exercise program: including aerobic exercise (running, jumping rope); Movements using body weight (barfix, squat) and weight lifting (front squat) are constantly changed using the CrossFit training pattern. The duration of each of the three workout programs is 20 minutes. Intervention 2: Intervention group2: In this group, according to the protocol, they will perform a high-intensity functional training program (HIFT) in 36 sessions of 60 minutes, in which CrossFit is used. and they will take 20 mg of astaxanthin capsules (Seongnam, South Korea) daily with breakfast for 12 weeks. Intervention 3: Intervention group3: In this group, according to the protocol, they will only do their daily exercises for 12 weeks and will be prohibited from participating in regular activities. and they will take 20 mg of astaxanthin capsules (Seongnam, South Korea) daily with breakfast for 12 weeks. Intervention 4: Control group: In this group, no treatment will be given and they will only do their daily exercises for 12 weeks and will be prohibited from participating in regular activities. They will receive 20 mg of raw corn starch capsules (placebo) daily with breakfast. It is only for comparison with intervention groups.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ayoub Saeidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Damghan branch; above Saadi square; Damghan.</address>
        <city>Damghan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3671637849</zip>
        <telephone>+98 23 3522 5045</telephone>
        <email>are20935@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ayoub Saeidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Damghan branch; above Saadi square; Damghan.</address>
        <city>Damghan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3671637849</zip>
        <telephone>+98 23 3522 5045</telephone>
        <email>are20935@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No addiction to drugs and alcohol
Not having a history of regular sports activity for at least 6 months
No history of kidney, liver, cardiovascular disease and diabetes
Not having any injury or physical problem
Body mass index (BMI)=30
Waist-to-height ratio (WHtR)&gt;0.5</inclusion_criteria>
      <agemin>23 years</agemin>
      <agemax>32 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Any psychological disorder to the individual's own report
Use of psychiatric drugs before conducting study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight and obesity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: In this group, according to the protocol, they will perform a high-intensity functional training program (HIFT) in 36 sessions of 60 minutes, in which CrossFit is used. Daily exercise program: including aerobic exercise (running, jumping rope); Movements using body weight (barfix, squat) and weight lifting (front squat) are constantly changed using the CrossFit training pattern. The duration of each of the three workout programs is 20 minutes.</i_keyword>
      <i_keyword>Intervention group2: In this group, according to the protocol, they will perform a high-intensity functional training program (HIFT) in 36 sessions of 60 minutes, in which CrossFit is used. and they will take 20 mg of astaxanthin capsules (Seongnam, South Korea) daily with breakfast for 12 weeks.</i_keyword>
      <i_keyword>Intervention group3: In this group, according to the protocol, they will only do their daily exercises for 12 weeks and will be prohibited from participating in regular activities. and they will take 20 mg of astaxanthin capsules (Seongnam, South Korea) daily with breakfast for 12 weeks.</i_keyword>
      <i_keyword>Control group: In this group, no treatment will be given and they will only do their daily exercises for 12 weeks and will be prohibited from participating in regular activities. They will receive 20 mg of raw corn starch capsules (placebo) daily with breakfast. It is only for comparison with intervention groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adipokines. Timepoint: The first fasting blood sample 48 hours before and the second blood sample 48 hours after the twelve-week training period from the right arm. Method of measurement: They will be measured using laboratory kits and ELISA devices.</prim_outcome>
      <prim_outcome>Myokines. Timepoint: The first fasting blood sample 48 hours before and the second blood sample 48 hours after the twelve-week training period from the right arm. Method of measurement: They will be measured using laboratory kits and ELISA devices.</prim_outcome>
      <prim_outcome>Hepatokines. Timepoint: The first fasting blood sample 48 hours before and the second blood sample 48 hours after the twelve-week training period from the right arm. Method of measurement: They will be measured using laboratory kits and ELISA devices.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-24</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Damghan branch</contact_name>
        <contact_address>Islamic Azad University, Damghan branch; above Saadi square; Damghan. Damghan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
