<?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>IRCT20200722048167N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-08</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of aerobic training and omega-3 exercise on oxidative and inflammatory elements in obese women</public_title>
      <acronym></acronym>
      <scientific_title>Effects of aerobic training and omega-3 supplementation on the levels of Paraoxonase, myeloperoxidase and some inflammatory and oxidative markers in overweight and obese women’s</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49833</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Prevention, Randomization description: Using the lottery method, the names of the subjects on a piece of paper It is written separately and placed inside a container then the names of the subjects are removed and is placed in the intervention group or placebo. The first 30 names are placed in the intervention group and the rest in the placebo group, Blinding description: Placebo and supplement Omega 3 are placed inside the similar capsules. Patients 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: Intervention group: Omega 3 supplement group (taking  omega 3 supplement, not participating in aerobic exercise program):for 8 weeks and daily 2000 mg of omega 3 fatty  acid supplement in the form of two 1000 mg capsules containing 360 mg of Eicosa pentanoic acid and 240 mg of Docosa hexaenoic acid (morning and night) made by Karen)and do the activities of daily living. Intervention 2: Intervention group: Aerobic training group (participation in aerobic training program- not taking omega3 supplements):The training program including 8 weeks of aerobic training(Running or fast walking) every week 3 sessions. Intensity of training in the first two weeks 50 to  55%, in the second two weeks 55 to 60%, in the third two weeks 60 to 65% and in the fourth two weeks 65 to 70% maximum heart rate is designed and the duration of each exercise session is about 25 It is minutes. Before and after each exercise session, 10 minutes of warm-up and eight minutes of cooling are performed, respectively.During this week, take placebo capsules morning and night. (Similar to omega-3 capsules but containing oral paraffin).Made by Darogster Company. Intervention 3: Intervention group: Aerobic training group + omega 3 supplement (taking omega 3 supplement and simultaneously participating in aerobic training  program ): for 8 weeks and daily 2000 mg of omega 3 fatty acid supplement in the form of two 1000 mg capsules containing 360 mg of Eicosa pentanoic acid and 240 mg of Docosa hexaenoic acid (morning and night) made by  Karen) in addition to the training program including 8 weeks of aerobic training (Running or fast walking)every week 3 sessions. Intensity of training in the first two weeks 50 to 55%, in the second two weeks 55 to 60%, in the third two weeks 60 to 65% and in the fourth two weeks 65 to 70% maximum heart rate is designed and the duration of each exercise session is about 25 It is minutes. Before and after each exercise session, 10 minutes of warm-up and eight minutes of cooling are performed, respectively. Intervention 4: Control group: Placebo group (not participating in aerobic exercise program, not taking omega 3 supplements) During these 8 weeks, take placebo capsules morning and night.  (Similar to omega-3 capsules but containing oral paraffin) Made by Darogster Company,In addition to daily life activities.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shila Montazer</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Alley 2 West 2، Elahieh Street،Nasr Boulevard</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618698181</zip>
        <telephone>+98 34 3245 3916</telephone>
        <email>shilamontazer@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Ali Azarbayjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shohada of Hesarak Boulevard,University Square,Shahid Sattari Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 4486 9827</telephone>
        <email>M_Azarbayjani@iauctb.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 25 to 40 years;
Physical health;
Subjects' body mass index more than 25 kg / m2 and less than 35 kg / m2;
Ability to participate in aerobic exercise program;
Not participating in regular exercise for the past year;
No diagnosed diseases such as diabetes, cardiovascular, cancer, gastrointestinal diseases, liver, kidney, autoimmune diseases, inflammation, thyroid, polycystic ovary syndrome;
Do not take antihypertensive drugs or lipid-lowering drugs;
Do not take nutritional supplements for at least six months before the study.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>No signing informed consent
Smoking or drinking alcohol at least once a week
Use of contraceptives and nonsteroidal anti-inflammatory drugs (NSAIDs) in the last 3 months
Pregnancy and lactation</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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Omega 3 supplement group (taking  omega 3 supplement, not participating in aerobic exercise program):for 8 weeks and daily 2000 mg of omega 3 fatty  acid supplement in the form of two 1000 mg capsules containing 360 mg of Eicosa pentanoic acid and 240 mg of Docosa hexaenoic acid (morning and night) made by Karen)and do the activities of daily living</i_keyword>
      <i_keyword>Intervention group: Aerobic training group (participation in aerobic training program- not taking omega3 supplements):The training program including 8 weeks of aerobic training(Running or fast walking) every week 3 sessions. Intensity of training in the first two weeks 50 to  55%, in the second two weeks 55 to 60%, in the third two weeks 60 to 65% and in the fourth two weeks 65 to 70% maximum heart rate is designed and the duration of each exercise session is about 25 It is minutes. Before and after each exercise session, 10 minutes of warm-up and eight minutes of cooling are performed, respectively.During this week, take placebo capsules morning and night. (Similar to omega-3 capsules but containing oral paraffin).Made by Darogster Company</i_keyword>
      <i_keyword>Intervention group: Aerobic training group + omega 3 supplement (taking omega 3 supplement and simultaneously participating in aerobic training  program ): for 8 weeks and daily 2000 mg of omega 3 fatty acid supplement in the form of two 1000 mg capsules containing 360 mg of Eicosa pentanoic acid and 240 mg of Docosa hexaenoic acid (morning and night) made by  Karen) in addition to the training program including 8 weeks of aerobic training (Running or fast walking)every week 3 sessions. Intensity of training in the first two weeks 50 to 55%, in the second two weeks 55 to 60%, in the third two weeks 60 to 65% and in the fourth two weeks 65 to 70% maximum heart rate is designed and the duration of each exercise session is about 25 It is minutes. Before and after each exercise session, 10 minutes of warm-up and eight minutes of cooling are performed, respectively.</i_keyword>
      <i_keyword>Control group: Placebo group (not participating in aerobic exercise program, not taking omega 3 supplements) During these 8 weeks, take placebo capsules morning and night.  (Similar to omega-3 capsules but containing oral paraffin) Made by Darogster Company,In addition to daily life activities.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Paraoxonase 1. Timepoint: First, the end of the study. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>Myeloperoxidase. Timepoint: First, the end of the study. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>Apolipoprotein A1. Timepoint: First, the end of the study. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>Apolipoprotein B. Timepoint: First, the end of the study. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>C-Reactive Protein. Timepoint: First, the end of the study. Method of measurement: Bionic Kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood Suger. 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>VO2 max. 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: Twice the height / weight.</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 Research Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-24</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University - University Scientific Unit</contact_name>
        <contact_address>Tehran - End of Shahid Sattari Highway - University Square - Hesarak Martyrs Boulevard Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
