<?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>IRCT20211107052994N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-25</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect  of combined training with Zataria multiflora supplementation on  lipid profile and some cardiovascular risk factors in inactive men</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks of combined training with Zataria multiflora supplementation on ANGPTL3, ANGPTL4, ANGPTL8, lipid profile and some cardiovascular risk factors in inactive men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59874</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Prevention, Blinding description: In order to eliminate the error caused by the knowledge of the participants and the researcher to the type of treatment received and its possible effect on the research result,we do the study in two blind directions.Placebo andZataria multiflora   supplements are placed inside the capsule in exactly the same way. As a result, participants and researchers are not aware of the type of supplement received.</study_design>
      <phase>3</phase>
      <hc_freetext>Inactive men.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Failure to participate in the combined exercise program, consumption of placebo capsules for 8 weeks with the content of wheat flour made by Gol Daroo company in addition to daily life activities. Intervention 2: Intervention group: Zataria multiflora supplement group (taking Zataria multiflora supplement, not participating in aerobic exercise program) for 8 weeks and daily 500 mg of thyme supplement made by Gol Daroo company after breakfast with 100 ml of water and daily activities of life. Intervention 3: Intervention group: Combined training group + Zataria multiflora supplement (taking Zataria multiflora supplement and simultaneously participating in the combined training program) for 8 weeks and 500 mg of thyme supplement made by Gol Darob Company daily, in addition to the training program, including 8 weeks of combined training, 3 sessions per week. Includes 30 minutes of aerobic exercise with an intensity of 60 to 70% of maximum heart rate and 30 minutes of resistance training with a maximum intensity of 10 repetitions.Before and after each exercise session, warm up for 10 minutes and cool down for 7 minutes. Intervention 4: Intervention group: Combined exercise group. The training program includes 8 weeks of combined training, 3 sessions per week. 30 minutes of aerobic exercise with an intensity of 60 to 70% of maximum heart rate and 30 minutes of resistance training with a maximum intensity of 10 repetitions are designed.  Before and after each exercise session, warm up for 10 minutes and cool down for 7 minutes.</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 This is because the sampling and clinical trial procedures are not yet complete.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arash Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.36 ,negin gharb town, highway ardestani</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998684911</zip>
        <telephone>+98 21 4499 7017</telephone>
        <email>arash12601@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mandana Gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shohada Hesarak Boulevard, University Square, Shahid Sattari Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 4486 5179</telephone>
        <email>gholami_man@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No cardiovascular disease and diabetes
Not participating in physical activity in the past year
No physical and medical restrictions for exercising</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>37 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Alcohol and drug use
Allergy toZataria multiflora  supplements
Taking supplements or medications in the last 6 months</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>Placebo</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Failure to participate in the combined exercise program, consumption of placebo capsules for 8 weeks with the content of wheat flour made by Gol Daroo company in addition to daily life activities</i_keyword>
      <i_keyword>Intervention group: Zataria multiflora supplement group (taking Zataria multiflora supplement, not participating in aerobic exercise program) for 8 weeks and daily 500 mg of thyme supplement made by Gol Daroo company after breakfast with 100 ml of water and daily activities of life</i_keyword>
      <i_keyword>Intervention group: Combined training group + Zataria multiflora supplement (taking Zataria multiflora supplement and simultaneously participating in the combined training program) for 8 weeks and 500 mg of thyme supplement made by Gol Darob Company daily, in addition to the training program, including 8 weeks of combined training, 3 sessions per week. Includes 30 minutes of aerobic exercise with an intensity of 60 to 70% of maximum heart rate and 30 minutes of resistance training with a maximum intensity of 10 repetitions.Before and after each exercise session, warm up for 10 minutes and cool down for 7 minutes.</i_keyword>
      <i_keyword>Intervention group: Combined exercise group. The training program includes 8 weeks of combined training, 3 sessions per week. 30 minutes of aerobic exercise with an intensity of 60 to 70% of maximum heart rate and 30 minutes of resistance training with a maximum intensity of 10 repetitions are designed.  Before and after each exercise session, warm up for 10 minutes and cool down for 7 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Angiopoietin-like protein 3(ANGPTL3). Timepoint: First, the end of the study. Method of measurement: Elisa Kit.</prim_outcome>
      <prim_outcome>Angiopoietin-like protein 4(ANGPTL4). Timepoint: First, the end of the study. Method of measurement: Elisa Kit.</prim_outcome>
      <prim_outcome>Angiopoietin-like protein 8(ANGPTL8). Timepoint: First, the end of the study. Method of measurement: Elisa Kit.</prim_outcome>
      <prim_outcome>Total cholesterol. Timepoint: First, the end of the study. Method of measurement: Plasma serum.</prim_outcome>
      <prim_outcome>Tri glyceride(TG). Timepoint: First, the end of the study. Method of measurement: Plasma serum.</prim_outcome>
      <prim_outcome>C-Reactive Protein (CRP). Timepoint: First, the end of the study. Method of measurement: Bionic Kit.</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>Azad University -  Deputy of research and technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-04</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University - Research Sciences Unit</contact_name>
        <contact_address>13th floor, headquarters of the Ministry of Health, Treatment and Medical Education, Sima Iran St., Gharb Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
