<?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>IRCT201102232709N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-03-11</date_registration>
      <primary_sponsor>Vice-chancellor for Research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effects of pomegranate and orange juice in non-alcoholic fatty liver disease patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effects of pomegranate and orange juice on serum total antioxidant capacity, MDA, TNF-α, ALT and AST enzymes, lipoproteins, insulin resistance and metabolic syndrome indices in non- alcoholic fatty liver patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2530</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>non-alcoholic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: 250 ml/day pomegranate juice for 12 weeks. Intervention 2: 250ml/day orange juice for 12 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>Dr Farzad Shidfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number 60, Alvand street, Argentina square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1516846515</zip>
        <telephone>+98 21 8877 9118</telephone>
        <email>farzadshidfar@yahoo.com</email>
        <affiliation>Faculty of Public Health of Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Farzad Shidfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number 60, Alvand street, Argentina square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1516846515</zip>
        <telephone>+98 21 8877 9118</telephone>
        <email>farzadshidfar@yahoo.com</email>
        <affiliation>Faculty of Public Health of Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: signing written informed consent, age between 30 and 65, diagnosis of non-alcoholic fatty liver disease by fatty infiltration on ultrasound and abnormal serum liver function tests (AST or ALT&gt;30 u/l in men and &gt;20 in women), no smoking, BMI≥ 25, no pregnancy or lactation, no use of dietary supplements one month prior to enrollment, not having diabetes, renal impairment, acute heart disease, thyroid disease, other form of liver disease (viral or autoimmune hepatitis, metabolic and hereditary liver disease) and any diseases that can affect on body weight, not having severe gaining or losing weight diet in the 3 month prior to the enrollment, no use of medication that could affect body weight in the 3 month prior to the enrollment, no use of drugs that induces steatosis (amidarone, methotrexate, systemic glucocorticoid, tetracycline, tamoxifen, estrogen, anabolic steroids, valporic acid) &#13;
Exclusion Criteria: those who are not interested in participating in the study, pharmacological treatment with some potential treatment, any diseases which need special treatment, pregnancy during the study period</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>250 ml/day pomegranate juice for 12 weeks</i_keyword>
      <i_keyword>250ml/day orange juice for 12 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>AST enzyme. Timepoint: before &amp; after intervention (after 12 weeks intervention. Method of measurement: enzymatic colorimetry kit.</prim_outcome>
      <prim_outcome>ALT enzyme. Timepoint: before &amp; after intervention (after 12 weeks intervention. Method of measurement: enzymatic colorimetry kit.</prim_outcome>
      <prim_outcome>Hepatic fat infiltration status. Timepoint: before &amp; after intervention (after 12 weeks intervention. Method of measurement: ultrasound.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>MDA. Timepoint: before &amp; after intervention (after 12 weeks intervention. Method of measurement: colorimetry kit.</sec_outcome>
      <sec_outcome>TNF-α. Timepoint: before &amp; after intervention (after 12 weeks intervention. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Total antioxidant capacity. Timepoint: before &amp; after intervention (after 12 weeks intervention. Method of measurement: colorimetry kit.</sec_outcome>
      <sec_outcome>Fasting Insulin Level. Timepoint: before &amp; after intervention (after 12 weeks intervention). Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Fastinf blood sugar. Timepoint: before &amp; after intervention (after 12 weeks intervention). Method of measurement: enzymatic colorimetry kit.</sec_outcome>
      <sec_outcome>HOMA-R. Timepoint: before &amp; after intervention (after 12 weeks intervention). Method of measurement: Calculating.</sec_outcome>
      <sec_outcome>LDL-C. Timepoint: before &amp; after intervention (after 12 weeks intervention). Method of measurement: immunoturbidimetry.</sec_outcome>
      <sec_outcome>HDL-C. Timepoint: before &amp; after intervention (after 12 weeks intervention). Method of measurement: immunoturbidimetry.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: before &amp; after intervention (after 12 weeks intervention). Method of measurement: colorimetry.</sec_outcome>
      <sec_outcome>Total colestrol. Timepoint: before &amp; after intervention (after 12 weeks intervention). Method of measurement: colorimetry.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: before &amp; after intervention (after 12 weeks intervention). Method of measurement: sphygmomanometer.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Gastrointestinal &amp; Liver Disease Research Center (Firoozgar GILDRC)</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, Tehran University of Medical Sciences</source_name>
      <source_name>Gastrointestinal &amp; Liver Disease Research Center (Firoozgar GILDRC)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-10-10</approval_date>
        <contact_name>Faculty of Public Health of Tehran University of Medical Sciences</contact_name>
        <contact_address>Number 60, Alvand street, Argentina square, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
