<?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>IRCT201111218145N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-02-16</date_registration>
      <primary_sponsor>Vice chancellor for research, Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of weight loss diets on long-term consequences of fatty liver disease in patients referred to the clinic Motahari Shiraz, 1390</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the effect of low calorie balanced diet   versus low calorie high fiber diet on the hepatic transaminases, lipid profiles, insulin, glucose levels, blood pressure and anthropometric measurements of obese patients with nonalcoholic fatty liver disease(NAFLD)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8571</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Nonalcoholic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: Receive a balanced low-calorie high-fiber diet for 3 months (reduction of 700 kcal daily intake and received more than 15 grams of fiber per 1,000 kcal according to the definition of high-fiber diet(. Intervention 2: Receive a balanced low-calorie diet for 3 months (reduction of 700 kcal daily intake and get as much as 14 grams of fiber per 1000 kcal intake according to the definition of balanced diet).</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>Bayan Roohi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Street, Department of Nutrition, School of Health and Nutrition</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>PO Box 715367-5541</zip>
        <telephone>+98 71 1725 1001</telephone>
        <email>bayan.roohi@yahoo.com  rouhib@sums.ac.ir</email>
        <affiliation>School of Health And Nutrition, Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mosa Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Street, Department of Nutrition, School of Health and Nutrition</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>PO Box 715367-5541</zip>
        <telephone>+98 71 1725 1001</telephone>
        <email>salehi@sums.ac.ir</email>
        <affiliation>School of Health and Nutrition, Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Age 20-60; BMI&gt;25; ALT&gt;43&#13;
&#13;
Exclusion criteria: Alcohol consumption; Hepatitis B; C; Cytomegalovirus; Epstein Barr infections; nonorgan-specific autoantibody hereditary defects (iron storage disease and copper; alpha-1 anti-trypsin deficiency)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nonalcoholic steatohepatitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Receive a balanced low-calorie high-fiber diet for 3 months (reduction of 700 kcal daily intake and received more than 15 grams of fiber per 1,000 kcal according to the definition of high-fiber diet(</i_keyword>
      <i_keyword>Receive a balanced low-calorie diet for 3 months (reduction of 700 kcal daily intake and get as much as 14 grams of fiber per 1000 kcal intake according to the definition of balanced diet)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>ALT. Timepoint: Before and 3 months after intervention. Method of measurement: Colorimetric method.</prim_outcome>
      <prim_outcome>AST. Timepoint: Before and 3 months after intervention. Method of measurement: Colorimetric method.</prim_outcome>
      <prim_outcome>GGT. Timepoint: Before and 3 months after intervention. Method of measurement: Colorimetric method.</prim_outcome>
      <prim_outcome>Bilirubin total. Timepoint: Before and 3 months after intervention. Method of measurement: Colorimetric method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Insulin. Timepoint: Before and 3  months after intervention. Method of measurement: ELISA kit.</sec_outcome>
      <sec_outcome>Lipid profile. Timepoint: Before and 2 months after intervention. Method of measurement: Auto analyzer.</sec_outcome>
      <sec_outcome>FBS. Timepoint: Before and 2 months after intervention. Method of measurement: Auto analyzer.</sec_outcome>
      <sec_outcome>Body fat mass. Timepoint: Before and 3 months after intervention. Method of measurement: Body Composition Analyzer - Quad Scan 4000.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before and 3 months after intervention. Method of measurement: Mercury Barometer.</sec_outcome>
      <sec_outcome>Weight. Timepoint: Before and 3 months after intervention. Method of measurement: Seca Scale.</sec_outcome>
      <sec_outcome>Height, waist hip circumference. Timepoint: Before and 3 months after intervention. Method of measurement: Tape Meter.</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, Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-11-12</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand Avenue, Central Medical Building, Shiraz Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
