<?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>IRCT138812223550N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2009-09-23</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of olive oil rich diet consumption on serum omentin  concentration</public_title>
      <acronym></acronym>
      <scientific_title>The effect of olive oil rich diet consumption on serum omentin concentration in overweight women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>16</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3644</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Basic scienece.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Serum omentin concentration in owerweight women. Condition 2: Overweight.</hc_freetext>
      <i_freetext>Intervention 1: Diet rich in olive oil with composition:51% carbohydrate.15% protein. 34% fat.8% SFA.10% PUFA.16% MUFA  for six weeks. Intervention 2: Common diet with composition:51% carbohydrate.15% protein. 34% fat.16% SFA.10% PUFA.8% MUFA  for six weeks.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fahimeh Haghighatdoost</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Public health,Tehran University of Medical Sciences, Enghelab square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1230 4119</telephone>
        <email>f_haghighatdoost@yahoo.com</email>
        <affiliation>Faculty of Public health,Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Javad Hosseinzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition and biochemistry group, faculty of Public health,tehran University of Medical Sciences, Enghelab square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8895 1395</telephone>
        <email>hosseinzadeh.mdphd@yahoo.com ; mjha3@yahoo.com</email>
        <affiliation>Nutrition and biochemistry group, faculty of Public health,Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: married women age: 20-50-year, BMI between 25-29/9, absence of clinical signs or symptoms of coronary artery disease, diabetes, metabolic diseases, arthritis, lupus, GI diseases, hypertension, any kind of infection, trauma, thyroid diseases, without history of using drugs, such as anti- hypertensive, anti hyperlipidemia, anti-inflammatory, anti diabetic agents, drugs for weight reduction, OCP, corticosteroids, not pregnancy and lactation, not smoking. Exclusion criteria: pregnancy, breast feeding, presence of any disease and use of drugs that mentioned above, don’t follow the diets</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>-</hc_code>
      <hc_code>E66.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>-</hc_keyword>
      <hc_keyword>Obesity due to excess calories</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Diet rich in olive oil with composition:51% carbohydrate.15% protein. 34% fat.8% SFA.10% PUFA.16% MUFA  for six weeks</i_keyword>
      <i_keyword>Common diet with composition:51% carbohydrate.15% protein. 34% fat.16% SFA.10% PUFA.8% MUFA  for six weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum omentin concentration. Timepoint: At the beginning and at the end of phase one and two. Method of measurement: Elisa kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Plasma adiponectin concentration. Timepoint: At the beginning and at the end of phase one and two. Method of measurement: Elisa kit.</sec_outcome>
      <sec_outcome>C- reactiv protein. Timepoint: At the beginning and at the end of phase one and two. Method of measurement: Elisa kit.</sec_outcome>
      <sec_outcome>Insulin. Timepoint: At the beginning and at the end of phase one and two. Method of measurement: Elisa kit.</sec_outcome>
      <sec_outcome>Fasting blood glucose. Timepoint: At the beginning and at the end of phase one and two. Method of measurement: Elisa kit.</sec_outcome>
      <sec_outcome>Lipid profile(cholestrol-triglicerid-HDL-LDL). Timepoint: At the beginning and at the end of phase one and two. Method of measurement: Elisa kit.</sec_outcome>
      <sec_outcome>Weight. Timepoint: At the beginning and at the end of phase one and two. Method of measurement: Seca digital scale.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: At the beginning and at the end of phase one and two. Method of measurement: Calculate.</sec_outcome>
      <sec_outcome>Body fat mass. Timepoint: At the beginning and at the end of phase one and two. Method of measurement: Bioempedance device.</sec_outcome>
      <sec_outcome>Waist and hip circumference. Timepoint: At the beginning and at the end of phase one and two. Method of measurement: Meter.</sec_outcome>
      <sec_outcome>Waist to hip ratio. Timepoint: At the beginning and at the end of phase one and two. Method of measurement: Calculate.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: At the beginning and at the end of phase one and two. Method of measurement: Manometer.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date></approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Ghods Ave. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
