<?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>IRCT2015012720841N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-02-12</date_registration>
      <primary_sponsor>Vice-Chancellery of Research and Technology</primary_sponsor>
      <public_title>Effect of the modified Mediterranean diet for prevention of metabolic syndrome in patients undergoing liver transplantation</public_title>
      <acronym></acronym>
      <scientific_title>Incidence of metabolic syndrome and the effect of the modified Mediterranean diet for prevention of metabolic syndrome in patients undergoing liver transplantation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18415</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Metabolic Syndrome. Condition 2: Metabolic Syndrome. Condition 3: Metabolic Syndrome. Condition 4: Metabolic Syndrome. Condition 5: Metabolic Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: In treatment group, a MMD with some changes in its contents in response to Iranian dietary culture and adapted with anthropomorphic conditions for 16 weeks. This diet rich in whole grains, legumes, vegetables, fruits consumed in the diet of fat is olive oil and canola oil, daily consumption of white meat and red meat consumption will be weekly. The regime will use low-fat dairy and sugar consumption is extremely low. Intervention 2: Control group  will use diet and training routine that normally provided by the hospital nutritionists.</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>Seyed Jalil Masoumi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>BLV Razi,School of Nutrition and Food Sciences, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 3725 1001</telephone>
        <email>massoumij@sums.ac.ir</email>
        <affiliation>​Department of Clinical Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medic</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Jalil Masoumi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>BLV Razi, School of Nutrition and Food Sciences, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 3725 1001</telephone>
        <email>massoumij@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:age over 18 exclusion criteria: age under 18; patient with any malignancy; multivisceral transplant; malignancy during study; Patients who do not want to cooperate</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E78.1</hc_code>
      <hc_code>I10</hc_code>
      <hc_code>R73</hc_code>
      <hc_code>R63.5</hc_code>
      <hc_code>E78.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pure hyperglyceridaemia</hc_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
      <hc_keyword>Elevated blood glucose level</hc_keyword>
      <hc_keyword>Abnormal weight gain</hc_keyword>
      <hc_keyword>Lipoprotein deficiency</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In treatment group, a MMD with some changes in its contents in response to Iranian dietary culture and adapted with anthropomorphic conditions for 16 weeks. This diet rich in whole grains, legumes, vegetables, fruits consumed in the diet of fat is olive oil and canola oil, daily consumption of white meat and red meat consumption will be weekly. The regime will use low-fat dairy and sugar consumption is extremely low.</i_keyword>
      <i_keyword>Control group  will use diet and training routine that normally provided by the hospital nutritionists.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood Pressure. Timepoint: Every 4 weeks till 16 weeks. Method of measurement: By a sphygmomanometer.</prim_outcome>
      <prim_outcome>Weight. Timepoint: Every 4 weeks till 16 weeks. Method of measurement: Iranian Rasa company scale.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: Every 4 weeks till 16 weeks. Method of measurement: Meters of fabric.</prim_outcome>
      <prim_outcome>Blood suger tests. Timepoint: Every 4 weeks till 16 weeks. Method of measurement: by an automated clinical chemistry analyzer.</prim_outcome>
      <prim_outcome>Lipid profile ( TG,CHOL,HDL-C,LDL-C ). Timepoint: Every 4 weeks till 16 weeks. Method of measurement: By an automated clinical chemistry analyzer.</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>Vice-Chancellery of Research and Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-12-21</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
