<?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>IRCT2016011125957N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-02-07</date_registration>
      <primary_sponsor>Oil Version Factory</primary_sponsor>
      <public_title>The effect of flaxseed oil in the treatment of non-alcoholic fatty liver</public_title>
      <acronym></acronym>
      <scientific_title>Compare the effect of flaxseed and sunflower oil on anthropometric characteristics, pressure and blood lipids and liver enzymes in patients with nonalcoholic fatty liver in overweight patients with a low-calorie diet</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21643</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Nonalcoholic Fatty Liver.</hc_freetext>
      <i_freetext>Intervention 1: The control group consisted of 40 patients. Randomly placed in this group. 20 grams per day for 3 months receive sunflower oil. Diet and recommendations are presented separately for each person. The exact consumption of oil is measured by graded modules. Outcomes measured before and after the intervention. At the beginning and end of study and end of each month, 3-day recall, blood pressure and anthropometric indices will be taken. Intervention 2: The intervention group consisted of 40 patients. Randomly placed in this group. 20 grams per day for 3 months receive flaxseed oil. Diet and recommendations are presented separately for each person. The exact consumption of oil is measured by graded modules. Outcomes measured before and after the intervention. At the beginning and end of study and end of each month, 3-day recall, blood pressure and anthropometric indices will be taken.</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>Doctor Masume Akhlaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz, Iran, Razi School of Nutrition and Food Science</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71372510018</telephone>
        <email>shahlarezaei13932014@gmail.com</email>
        <affiliation>Department of Food Science and Nutrition</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Doctor Masume Akhlaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz, Razi Blvd.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+7 1372510018</telephone>
        <email>shahlarezaei13932014@gmail.com</email>
        <affiliation>Department of Nutrition and Food Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: having NAFLD by medical diagnosis (using ultrasound) ; BMI = 25 and above ; willingness to participate in the study, the absence of diabetes mellitus type 2 ;heart disease ;cardiovascular and liver disease (cirrhosis, liver disease Alcohol, viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, biliary obstruction, liver damage induced by drugs hereditary Hemochromatosis, sclerosis cholangitis and antitrypsin deficiency of α-a-1) ;other serious diseases such as cancer ;kidney failure and celiac disease, etc) ;lack of pregnancy ;lactation ;lack of drugs that are causing fatty liver (methotrexate, tamoxifen, Valproate, etc.) ;avoiding the use of any type of lipid lowering agents (atorvastatin, lovastatin, pravastatin, etc.) ;fibrates (gemfibrozil, fenofibrate) ;lack of malnutrition ;have no special diets such as vegan and vegetarian ;not drinking alcohol and having over 18 years of age. Exclusion criteria: non-compliance with recommended diet for more than 15 days over 3 months ;acute or infectious disease ;hospitalization or in cases where the criteria mentioned is.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</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>(Nonalcoholic fatty liver disease (NAFLD</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The control group consisted of 40 patients. Randomly placed in this group. 20 grams per day for 3 months receive sunflower oil. Diet and recommendations are presented separately for each person. The exact consumption of oil is measured by graded modules. Outcomes measured before and after the intervention. At the beginning and end of study and end of each month, 3-day recall, blood pressure and anthropometric indices will be taken.</i_keyword>
      <i_keyword>The intervention group consisted of 40 patients. Randomly placed in this group. 20 grams per day for 3 months receive flaxseed oil. Diet and recommendations are presented separately for each person. The exact consumption of oil is measured by graded modules. Outcomes measured before and after the intervention. At the beginning and end of study and end of each month, 3-day recall, blood pressure and anthropometric indices will be taken.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: Before the intervention, after the intervention and the end of each month. Method of measurement: Barometer.</prim_outcome>
      <prim_outcome>Lipid profile. Timepoint: Before the intervention, after intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Anthropometric indices. Timepoint: Before the intervention, after the intervention and the end of each month. Method of measurement: Devices BIA, scales, meters.</prim_outcome>
      <prim_outcome>Liver enzymes. Timepoint: Before the intervention, after intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Changing in the degree of fatty liver. Timepoint: Before the intervention, after the intervention. Method of measurement: Ultrasound.</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>Oil Version Factory</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-13</approval_date>
        <contact_name>Shiraz University of Medical Sciences, School of Nutrition</contact_name>
        <contact_address>Shiraz, Razi Blvd. Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
