<?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>IRCT20210715051899N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-09</date_registration>
      <primary_sponsor>The university of Tabriz</primary_sponsor>
      <public_title>The effect of two training methods on obesity hormons</public_title>
      <acronym></acronym>
      <scientific_title>The effect of two training methods of high-intensity interval training and high-intensity circuit training on serum levels of Asprosin, Glypican_4 and Lipid profile in over weight and obese women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59110</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Unique exercises methods.</study_design>
      <phase>N/A</phase>
      <hc_freetext>obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: high intensity interval training (HIIT).The subjects' training period will include 10 weeks of familiarization (preparation) for 10 weeks and three sessions per week. The first two weeks will be done to prepare for the heavy HIIT workouts. Then the main exercises will start from the third week. Subjects in the HIIT training group will perform three sessions of HIIT training at maximum intensity each week. The first and second weeks include 3 sets of 6 repetitions (each repetition 15 seconds and rest between repetitions 6-1), the third and fourth week 3 sets of 5 repetitions (each repetition 20 seconds and rest between repetitions 5-1) and the fifth and sixth week 3 sets of 4 repetitions (25 repetitions per repetition and rest between repetitions 4-1) The seventh and eighth week will be 3 sets of 4 repetitions (each repetition 30 seconds and rest between repetitions 4-1). Intervention 2: Intervention group: high intensity circuit training (HICT).These exercises will be done 3 sessions a week with maximum intensity. Each session will include 12 exercises. The duration of each movement in the first and second week will be 20 seconds and each cycle 2 times, in the third and fourth week 25 seconds and each cycle 3 times, the fifth to eighth week 30 seconds and each cycle 4 times. The rest time between movements will be 30 to 60 seconds and between cycles will be 3 minutes. Intervention 3: Intervention group: Control group: This group does not exercise. Only basic measurements such as anthropometric features and blood sampling will be performed.</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 I have not decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ramin Amirsasan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>29 Bahman Blvd., Imam Khomeini St., University of Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166616471</zip>
        <telephone>+98 41 3339 3255</telephone>
        <email>amirsasan@tabrizu.ac.ir</email>
        <affiliation>The university of tabriz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ramin Amirsasan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>29 Bahman Blvd., Imam Khomeini St., University of Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166616471</zip>
        <telephone>+98 41 3339 3255</telephone>
        <email>raminamirsasan@gmail.com</email>
        <affiliation>The university of tabriz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Overweight and obese non-athlete women (28% BMI) in the age range of 30 to 45 years
Homogeneous individual characteristics (age, sex, body mass index, fat percentage)
Do not smoke or drink alcohol</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Women with any chronic illness
Women who exercise regularly and take sports supplements
Women who have gone through menopause</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66. 9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: high intensity interval training (HIIT).The subjects' training period will include 10 weeks of familiarization (preparation) for 10 weeks and three sessions per week. The first two weeks will be done to prepare for the heavy HIIT workouts. Then the main exercises will start from the third week. Subjects in the HIIT training group will perform three sessions of HIIT training at maximum intensity each week. The first and second weeks include 3 sets of 6 repetitions (each repetition 15 seconds and rest between repetitions 6-1), the third and fourth week 3 sets of 5 repetitions (each repetition 20 seconds and rest between repetitions 5-1) and the fifth and sixth week 3 sets of 4 repetitions (25 repetitions per repetition and rest between repetitions 4-1) The seventh and eighth week will be 3 sets of 4 repetitions (each repetition 30 seconds and rest between repetitions 4-1)</i_keyword>
      <i_keyword>Intervention group: high intensity circuit training (HICT).These exercises will be done 3 sessions a week with maximum intensity. Each session will include 12 exercises. The duration of each movement in the first and second week will be 20 seconds and each cycle 2 times, in the third and fourth week 25 seconds and each cycle 3 times, the fifth to eighth week 30 seconds and each cycle 4 times. The rest time between movements will be 30 to 60 seconds and between cycles will be 3 minutes.</i_keyword>
      <i_keyword>Intervention group: Control group: This group does not exercise. Only basic measurements such as anthropometric features and blood sampling will be performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Asprosin. Timepoint: At the beginning of the study after 12 hours of fasting and 48 hours after the end of the exercise period. Method of measurement: Blood sampling and evaluation of serum levels.  The ELISA kit will be used.</prim_outcome>
      <prim_outcome>Glypican-4. Timepoint: At the beginning of the study after 12 hours of fasting and 48 hours after the end of the exercise period. Method of measurement: Blood sampling and evaluation of serum levels.  The ELISA kit will be used.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: At the beginning of the study after 12 hours of fasting and 48 hours after the end of the exercise period. Method of measurement: Blood sampling and evaluation of serum levels.  Photometric method will be used.</prim_outcome>
      <prim_outcome>Total Cholesterol. Timepoint: At the beginning of the study after 12 hours of fasting and 48 hours after the end of the exercise period. Method of measurement: Blood sampling and evaluation of serum levels.  Photometric method will be used.</prim_outcome>
      <prim_outcome>High density lipoprotein. Timepoint: At the beginning of the study after 12 hours of fasting and 48 hours after the end of the exercise period. Method of measurement: Blood sampling and evaluation of serum levels.  Photometric method will be used.</prim_outcome>
      <prim_outcome>Low density lipoprotein. Timepoint: At the beginning of the study after 12 hours of fasting and 48 hours after the end of the exercise period. Method of measurement: Blood sampling and evaluation of serum levels.  Photometric method will be used.</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 Tabriz</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-29</approval_date>
        <contact_name>Biomedical Ethics Committee of Tabriz University</contact_name>
        <contact_address>Tabriz. 29 Bahman Boulevard. Tabriz University. Biomedical Ethics Committee of Tabriz University Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
