<?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>IRCT20200811048360N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-16</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of aerobic training and Omega 3 ingestion on the levels of Adipsin and insulin resistance</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of eight week aerobic training and Omega 3 ingestion on the levels of Adipsin and insulin resistance in overweight and obese women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50261</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Prevention, Randomization description: Simple randomization is performed. Once the participants were identified, their names were randomly written into a list, identifying each person with a number. Then, we randomly selected a number by moving the mouse. From that number to the tenth number were located in the placebo group, the eleventh to the twentieth in the supplement group, the twenty-first to the thirtieth in the aerobic exercise group and the remaining ten people in the supplement and aerobic exercise group, Blinding description: Participants are blind to being in the intervention or control group. The researcher is also  blind to the participants  being in the supplement or placebo group. Orientation sessions are held separately for the two groups receiving aerobic exercise. All participants are asked not to exercise outside the program during the research period.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Overweight and obesity.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: Aerobic Exercise For eight weeks and three sessions per week, Exercise intensity is 50-55% in the first two weeks, 55-60% in the second two weeks, 60-65% in the third two weeks, and 65-70% in the fourth two weeks. The duration of each exercise session is about 25 minutes. 10 minutes of warm-up and eight minutes of cooling are performed before and after each exercise session, respectively. Intervention 2: 2nd intervention group: omega-3 supplement, 2000 mg daily, taken in two capsules of 1000 mg in the morning and evening (with or after breakfast and dinner). Omega 3 purchased from Karen Company. Intervention 3: 3rd intervention group: Aerobic exercise and omega 3 supplement. Aerobic Exercise For eight weeks and three sessions per week, Exercise intensity is 50-55% in the first two weeks, 55-60% in the second two weeks, 60-65% in the third two weeks, and 65-70% in the fourth two weeks. The duration of each exercise session is about 25 minutes. 10 minutes of warm-up and eight minutes of cooling are performed before and after each exercise session, respectively. And 2000 mg daily omega 3 supplement, taken in two capsules of 1000 mg in the morning and evening (with or after breakfast and dinner). Omega 3 purchased from Karen Company. Intervention 4: Control group: placebo (oral paraffin), 2000 mg daily, in the form of two 1000 mg capsules in the morning and evening (with or after breakfast and dinner).</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:
After the required time, the file containing patient information and research results will be provided only for research purposes to the research institutes or researchers who wish to research in this field

When:
Access period starts 6 months after the results are published

To whom:
Researchers working in scientific and academic institutions

Conditions:
It can be used for review and use in other research projects

Where to obtain:
Saleheh Ahmadzadeh  E-mail address: s_ahmadzadeh6612@yahoo.com

How to obtain:
Send a summary of the research project The relationship between the research project and the research should be announced

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saleheh Ahmadzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Science and Research Branch, Daneshgah Blvd, Daneshgah Sq, Simon Bulivar Blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 4486 5154</telephone>
        <email>s_ahmadzadeh6612@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mandana Gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Science and Research Branch, Daneshgah Blvd, Daneshgah Sq., Simon Bulivar Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 4486 5154</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>overweight and obese
Women in the age range of 25 to 40 years
Not participating in regular exercise at least last year</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Simultaneous participation in other sports training programs
Cardiovascular disease
Type 2 diabetes
High blood pressure
Malignant diseases such as cancer
Take nutritional supplements at least six months before the 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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: Aerobic Exercise For eight weeks and three sessions per week, Exercise intensity is 50-55% in the first two weeks, 55-60% in the second two weeks, 60-65% in the third two weeks, and 65-70% in the fourth two weeks. The duration of each exercise session is about 25 minutes. 10 minutes of warm-up and eight minutes of cooling are performed before and after each exercise session, respectively.</i_keyword>
      <i_keyword>2nd intervention group: omega-3 supplement, 2000 mg daily, taken in two capsules of 1000 mg in the morning and evening (with or after breakfast and dinner). Omega 3 purchased from Karen Company.</i_keyword>
      <i_keyword>3rd intervention group: Aerobic exercise and omega 3 supplement. Aerobic Exercise For eight weeks and three sessions per week, Exercise intensity is 50-55% in the first two weeks, 55-60% in the second two weeks, 60-65% in the third two weeks, and 65-70% in the fourth two weeks. The duration of each exercise session is about 25 minutes. 10 minutes of warm-up and eight minutes of cooling are performed before and after each exercise session, respectively. And 2000 mg daily omega 3 supplement, taken in two capsules of 1000 mg in the morning and evening (with or after breakfast and dinner). Omega 3 purchased from Karen Company.</i_keyword>
      <i_keyword>Control group: placebo (oral paraffin), 2000 mg daily, in the form of two 1000 mg capsules in the morning and evening (with or after breakfast and dinner).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Levels of Adipsin. Timepoint: Before the intervention, after the intervention. Method of measurement: Measurement of serum levels in participants' blood samples.</prim_outcome>
      <prim_outcome>Insulin resistance. Timepoint: Before the intervention, after the intervention. Method of measurement: Measurement of serum levels in participants' blood samples.</prim_outcome>
      <prim_outcome>Weight. Timepoint: Before the intervention, after the intervention. Method of measurement: seca scale.</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>2020-11-18</approval_date>
        <contact_name>Ethics Committee of Azad University, Science and Research Branch</contact_name>
        <contact_address>Azad University Science and Research Branch, Daneshgah boulevard, Daneshgah square, Simon Bulivar boulevard Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
