<?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>IRCT2016082429508N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-20</date_registration>
      <primary_sponsor>Vice chancellor for research, Urmia University of Medical Sciences</primary_sponsor>
      <public_title>The effect of hypocaloric diet and omega-3 fatty acid supplementation on overweight and obesity</public_title>
      <acronym></acronym>
      <scientific_title>The effect of a hypocaloric diet and omega-3 fatty acid supplementation on serum levels of liver enzymes, lipid profile and insulin resistance in overweight and obese patients with non-alcoholic fatty liver disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>114</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23698</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>Non-alcoholic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: Thirty eight patients with Nafld will receive a hypocaloric diet program consisting of 50% carbohydrates, 20% protein and 30% fat with a goal of 5% weight reduction. Dietary intake will assess by 24-hour recall method for 3 days and food frequency questionnaire at baseline and the end of the trial. Anthropometric measurements, fasting blood sugar, fasting insulin, lipid profile (TC, LDL-C, HDL-C, TG), HOMA-IR, liver enzyme (ALT and AST) and physical activity data will be collected at baseline and the end of the intervention. Intervention 2: Second intervention group: Thirty eight patients with Nafld will take 2 omega-3 fatty acids capsules per day providing 1500 mg EPA+DHA. Dietary intake will assess by 24-hour recall method for 3 days at baseline and the end of the trial. Anthropometric measurements, fasting blood sugar, fasting insulin, lipid profile (TC, LDL-C, HDL-C, TG), HOMA-IR, liver enzyme (ALT and AST) and physical activity data will be collected at baseline and the end of the interventio. Intervention 3: Control group: no intervention.</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. Rasoul Zarrin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of nutrition, Medicine Faculty, Nazlou Pardis , 11th km of Nazlou Road,Urmia,Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 44 3346 9935</telephone>
        <email>Rasoul.zarrin@uqconnect.edu.au; wwzarrin@yahoo.com</email>
        <affiliation>Urmia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. rasoul Zarrin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of nutrition, Medicine Faculty, Nazlou Pardis , 11th km of Nazlou Road,Urmia,Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 44 3346 9935</telephone>
        <email>Rasoul.zarrin@uqconnect.edu.au; wwzarrin@yahoo.com</email>
        <affiliation>Urmia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age between 18 and 65 years; the diagnosis of Nafld is established by the presence of steatosis of the liver on ultrasound associated with a persistent increase in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) of 1.5-4 times the upper limit of normal and AST:ALT&lt;1; body mass index between 25 and 40 kg/m2; having informed consent.&#13;
Exclusion criteria: pregnancy and lactation; alcohol consumption; substance abuse; engaging in strenuous exercise; any known pathological condition affecting the liver, e.g., autoimmune liver disease, hepatic virus infection, hepatobiliary disease,history of liver transplantation, hereditary defects (Wilson disease, hemochromatosis, ...), neoplasm, cardiovascular disease, endocrine disorders (diabetes mellitus, untreated hypothyroidism,...), bariatric surgery within the past year, engagement in an active weight loss program or taking weight-loss medication within the 3 months before the study, omega-3 fatty acid supplementation within the 3 months before the study; treatment with some medications (anticoagulant drugs, insulin-sensitizing drugs, statins, vitamin E), steatogenic and hepatotoxic medications and use of any medicine or dietary supplement that could influence glucose and lipid metabolism within the 3 months before the study.</inclusion_criteria>
      <agemin>18 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>Fatty (change of) liver, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: Thirty eight patients with Nafld will receive a hypocaloric diet program consisting of 50% carbohydrates, 20% protein and 30% fat with a goal of 5% weight reduction. Dietary intake will assess by 24-hour recall method for 3 days and food frequency questionnaire at baseline and the end of the trial. Anthropometric measurements, fasting blood sugar, fasting insulin, lipid profile (TC, LDL-C, HDL-C, TG), HOMA-IR, liver enzyme (ALT and AST) and physical activity data will be collected at baseline and the end of the intervention.</i_keyword>
      <i_keyword>Second intervention group: Thirty eight patients with Nafld will take 2 omega-3 fatty acids capsules per day providing 1500 mg EPA+DHA. Dietary intake will assess by 24-hour recall method for 3 days at baseline and the end of the trial. Anthropometric measurements, fasting blood sugar, fasting insulin, lipid profile (TC, LDL-C, HDL-C, TG), HOMA-IR, liver enzyme (ALT and AST) and physical activity data will be collected at baseline and the end of the interventio</i_keyword>
      <i_keyword>Control group: no intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.</prim_outcome>
      <prim_outcome>Fasting insulin. Timepoint: At baseline and after 3 month. Method of measurement: measured in microUnit/milliliter, using Elisa.</prim_outcome>
      <prim_outcome>HOMA-IR. Timepoint: At baseline and after 3 month. Method of measurement: using formula.</prim_outcome>
      <prim_outcome>High density lipoprotein (HDL-C). Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.</prim_outcome>
      <prim_outcome>Low density lipoprotein (LDL-C). Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.</prim_outcome>
      <prim_outcome>Total cholesterol. Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: At baseline and after 3 month. Method of measurement: measured in milligram per deciliter, using colorimetry method.</prim_outcome>
      <prim_outcome>Alanine aminotransferase (ALT). Timepoint: At baseline and after 3 month. Method of measurement: measured in international units/liter, using colorimetry method.</prim_outcome>
      <prim_outcome>Aspartate aminotransferase (AST). Timepoint: At baseline and after 3 month. Method of measurement: measured in international units/liter, using colorimetry method.</prim_outcome>
      <prim_outcome>Weight. Timepoint: At baseline and after 3 month. Method of measurement: measured in kilograms, using digital scale.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: At baseline and after 3 month. Method of measurement: measured in centimeter, using a soft tape.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: At baseline and after 3 month. Method of measurement: kg/m2, using standard formula.</prim_outcome>
      <prim_outcome>Height. Timepoint: At baseline and after 3 month. Method of measurement: measured in meter, using mounted tape.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physical activity level. Timepoint: At baseline and after 3 month. Method of measurement: international physical activity questionnaire short form (IPAQ-SF).</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, Urmia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-08-31</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>UMSU Central Site,Orjhans Street, Resalat Blvd, Urmia , Iran Urmia  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
