<?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>IRCT20200812048388N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-21</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of 12 weeks of combined training (aerobic-resistance) with thyme supplement on RBP-4, resistin, insulin resistance and body fat percentage in overweight and obese women</public_title>
      <acronym></acronym>
      <scientific_title>Effect of 12 weeks combined training (aerobic-resistance) and zataria multiflora supplementation on the levels of some inflammatory adipokines in overweight and obese women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52366</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Using the lottery method, the names of the subjects are written on separate papers and placed in a container, then the names of the subjects are randomly taken out and placed in the intervention group or placebo. The first 30 names in the intervention group and the rest They are in the placebo group, Blinding description: In order to eliminate the error caused by the participants' and researcher's knowledge of the type of treatment received and its possible effect on the research result, we conduct a two-way study. Due to the fact that thyme supplements are placed exactly the same inside the capsule, participants and researchers are not aware of the type of supplement received.</study_design>
      <phase>3</phase>
      <hc_freetext>Overweight and obesity.</hc_freetext>
      <i_freetext>Intervention 1: Control group: not participating in the combined exercise program, taking placebo for 12 weeks, taking thyme-like capsules with wheat flour content, made by Gol Daroo company, in addition to daily life activities. Intervention 2: Intervention group: Thyme supplement group (taking omega-thyme supplement, not participating in aerobic exercise program) for 12 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 exercise group. The training program includes 12 weeks of combined training, 3 sessions per week. 30 minutes of aerobic training 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, respectively. And cool for 7 minutes. Intervention 4: Intervention group: Combined training group + thyme supplement (taking thyme supplement and participating in the combined training program at the same time) for 12 weeks and 500 mg of thyme supplement made by Gol Darob Company daily. In addition, the training program includes 12 weeks of combined training, 3 sessions per week. Includes 30 minutes of aerobic exercise with an intensity of 60-70% of maximum heart rate and 30 minutes of resistance training with a maximum intensity of 10 repetitions are designed and before and after each exercise session, 10 minutes of warm-up and 7 minutes of cooling are performed, respectively.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Forough Darabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Punak, Mirzababaei intersection, Behesht 3, No. 10, Unit 8</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1476736434</zip>
        <telephone>+98 21 4489 1536</telephone>
        <email>19foroughdarabi91@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Forough Darabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Punak, Mirzababaei intersection, Behesht 3, No. 10, Unit 8</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1476736434</zip>
        <telephone>+98 21 4489 1536</telephone>
        <email>19foroughdarabi91@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Not participating in regular exercise during the last year
Not having type 2 diabetes, cardiovascular disease and high blood pressure
No systemic and malignant diseases including cancer
Do not consume whole drinks
Do not take medication or dietary supplements during the research period
Age range 35-20
Lack of physical restraint in order to participate in sports exercises
Signing informed consent</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Absence of more than one session in the exercise program
Allergy or sensitivity to thyme supplement
Compulsion to take medication or other nutritional supplements over a 12-week
periodInjury and inability of the subject to continue the training program
Failure to participate in one of the blood sampling steps (pre-test or post-test)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity due to excess calories</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: not participating in the combined exercise program, taking placebo for 12 weeks, taking thyme-like capsules with wheat flour content, made by Gol Daroo company, in addition to daily life activities</i_keyword>
      <i_keyword>Intervention group: Thyme supplement group (taking omega-thyme supplement, not participating in aerobic exercise program) for 12 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 exercise group. The training program includes 12 weeks of combined training, 3 sessions per week. 30 minutes of aerobic training 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, respectively. And cool for 7 minutes.</i_keyword>
      <i_keyword>Intervention group: Combined training group + thyme supplement (taking thyme supplement and participating in the combined training program at the same time) for 12 weeks and 500 mg of thyme supplement made by Gol Darob Company daily. In addition, the training program includes 12 weeks of combined training, 3 sessions per week. Includes 30 minutes of aerobic exercise with an intensity of 60-70% of maximum heart rate and 30 minutes of resistance training with a maximum intensity of 10 repetitions are designed and before and after each exercise session, 10 minutes of warm-up and 7 minutes of cooling are performed, respectively.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Retinol binding protein 4. Timepoint: First, the end of the study. Method of measurement: Kit Eliza.</prim_outcome>
      <prim_outcome>Resistin. Timepoint: First, the end of the study. Method of measurement: Kit Eliza.</prim_outcome>
      <prim_outcome>Insulin resistance. Timepoint: First, the end of the study. Method of measurement: Homa index.</prim_outcome>
      <prim_outcome>Fat percentage. Timepoint: First, the end of the study. Method of measurement: Body Analysis.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Glucose. Timepoint: First, the end of the study. Method of measurement: Glucose Test Kit.</sec_outcome>
      <sec_outcome>Insulin. Timepoint: First, the end of the study. Method of measurement: Insulin ELISA Kit.</sec_outcome>
      <sec_outcome>Maximum volume of oxygen consumption. Timepoint: First, the end of the study. Method of measurement: Rockport test and formula method.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: First, the end of the study. Method of measurement: kg/m2.</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>Vice Chancellor for Research, Faculty of Literature, Tehran University of Science and Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-14</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Gholum and Research Branch</contact_name>
        <contact_address>Tehran, end of Shahid Sattari Highway, University Square, Shohada Hesarak Boulevard Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
