<?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>IRCT20191207045644N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-04</date_registration>
      <primary_sponsor>The University of Tabriz</primary_sponsor>
      <public_title>Effect High-Intensity Interval Training on Appetite-related Hormones and Body Composition in Overweight and Obese Men</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Eight Weeks of two types of High-Intensity Interval Training on Appetite sensation, Appetite-related Hormones and Body Composition in Overweight and Obese Men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-03-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75530</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Simple randomization with dice-throw. So there are 3 groups. If the dice number is 1 or 2, in the first group, if 3 and 4 are in group 2, and if 5 and 6 are in group 3.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Not a disease (Hormonal levels, Body composition, Aerobic power and Performance).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 8 weeks of high-intensity interval training/ 3 sessions in a week according to vVo2max. Intervention 2: Intervention group: 8 weeks of high intensity functional training/ 3 sessions in a week including 6 full body exercises. Intervention 3: Control group: Daily activity without training.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Hormone levels and appetite sensation, and body composition data

When:
Start accessing 6 months after printing results

To whom:
Researchers working in academic and scientific institutions

Conditions:
To investigate the background of research in similar research

Where to obtain:
Vahid Fekri Kourabbaslou

How to obtain:
Send an Email to the researcher

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vahid Fekri Kourabbaslou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No3, Vatan pour alley- Ostad Jafari street, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5186843787</zip>
        <telephone>+98 41 3285 0094</telephone>
        <email>vfekri28@gmail.com</email>
        <affiliation>The University of Tabriz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vahid Fekri Kourabbaslou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No3, Vatan pour alley- Ostad Jafari street, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5186843787</zip>
        <telephone>+98 41 3285 0094</telephone>
        <email>vfekri28@gmail.com</email>
        <affiliation>The University of Tabriz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men with BMI over  25
Between 20-30 years old
Without any chronic diseases
Without any surgery during last year
No consumption of weight-loss and anti-inflammatory drugs during the last year
Lack of weight loss during the last year(more than 10%)
Lack of any programmed training experience during last year
Lack of any medical limitation.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Men with BMI below 25
Not being in the age range.
History of chronic diseases.
Experience of regular training program during the last year.
Having surgery during the last year.
Consumption of weight-loss and anti-inflammatory drugs during the last year
Medical limitation.
Consumption of supplement affecting muscle and adipose tissue metabolism during the last months.
Being female.
Smoking and alcohol consumption</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>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 8 weeks of high-intensity interval training/ 3 sessions in a week according to vVo2max</i_keyword>
      <i_keyword>Intervention group: 8 weeks of high intensity functional training/ 3 sessions in a week including 6 full body exercises.</i_keyword>
      <i_keyword>Control group: Daily activity without training</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ghrelin Hormone level. Timepoint: Pre and Post 8 weeks. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>Glucagon-like peptide 1 hormone lavel. Timepoint: Pre and Post 8 weeks. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>Peptide YY hormone level. Timepoint: Pre and Post 8 Weeks. Method of measurement: Bloos Sample.</prim_outcome>
      <prim_outcome>Body Composition. Timepoint: Pre and Post 8 Weeks. Method of measurement: Bioelectrical impedance analysis.</prim_outcome>
      <prim_outcome>Appetite sansation. Timepoint: Pre and Post 8 Weeks. Method of measurement: Appetite questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Vo2 max. Timepoint: Pre and Post 8 weeks. Method of measurement: Rockport test.</sec_outcome>
      <sec_outcome>VVo2max. Timepoint: Pre and Post 8 weeks. Method of measurement: 5 minutes vVo2max run test.</sec_outcome>
      <sec_outcome>Calorie intake. Timepoint: Pre, Post 4 and 8 weeks. Method of measurement: Dietary Recall Questionnaire.</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>2023-07-09</approval_date>
        <contact_name>Research Ethics committees of University of Tabriz</contact_name>
        <contact_address>University of Tabriz, 29 Bahman Boulevard, Tabriz, East Azerbaijan Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
