<?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>IRCT20170206032417N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-27</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Whole Grain Diet on Non-Alcoholic Fatty Liver</public_title>
      <acronym></acronym>
      <scientific_title>The effect of a diet enriched with whole grains or bran-contained cereals on liver echogenicity, liver function markers, anthropometry, insulin resistance, blood pressure and lipid profile in patients with nonalcoholic fatty liver disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28269</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Parallel controlled randomized, Blinding description: In this one-sided study, only participants are unaware of the allocation of study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-alcoholic fatty liver.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, people in the intervention group after become aware of foods that are considered as whole grains,for 3 months will change their daily intake of cereals from refined grain to whole grains or grains with bran. in order to provide at least four serving of whole grains,  And they will be asked to not change their physical activity during this time. Intervention 2: Control group: In this study, individuals in the control group were asked to take their usual daily intake of cereals for 3 months and not to change their physical activity.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I have not decided yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Alizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3275 2375</telephone>
        <email>alizadeh.m@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Alizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3275 2375</telephone>
        <email>alizadeh.m@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range over 18 years old in both sexes
Non-alcoholic fatty liver disease detected by ultrasound</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Alcohol consumption or history
Positive serology-hepatitis A-B-C
Pregnancy and lactation during the study
Diabetes
Hypothyroidism
Psychopathy
kidney Diseases
People who regularly receive at least half the daily cereals they consume from whole grains
A major change in lifestyle</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>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, people in the intervention group after become aware of foods that are considered as whole grains,for 3 months will change their daily intake of cereals from refined grain to whole grains or grains with bran. in order to provide at least four serving of whole grains,  And they will be asked to not change their physical activity during this time.</i_keyword>
      <i_keyword>Control group: In this study, individuals in the control group were asked to take their usual daily intake of cereals for 3 months and not to change their physical activity.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: At weeks 0,12. Method of measurement: Scale, kg.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: At weeks 0, 12. Method of measurement: Enzymatic method, mg\dl.</prim_outcome>
      <prim_outcome>Total cholesterol. Timepoint: At weeks 0,12. Method of measurement: Enzymatic method, mg\dl.</prim_outcome>
      <prim_outcome>LDL cholesterol. Timepoint: At weeks 0 ,12. Method of measurement: (LDL= Total cholestrol – (HDL+ TG/5)).</prim_outcome>
      <prim_outcome>HDL cholesterol. Timepoint: At weeks 0,12. Method of measurement: Enzymatic method, mg\dl.</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: At weeks 0,12. Method of measurement: Enzymatic method, mg\dl.</prim_outcome>
      <prim_outcome>Serum insulin. Timepoint: At weeks 0,12. Method of measurement: Radioimmunoassay.</prim_outcome>
      <prim_outcome>Alanine Aminotransferase. Timepoint: At weeks 0,12. Method of measurement: Enzymatic method, IU\ Lit.</prim_outcome>
      <prim_outcome>Aspartat transaminase. Timepoint: At weeks 0, 12. Method of measurement: Enzymatic method, IU\ Lit.</prim_outcome>
      <prim_outcome>Gamma Glutamyl transferase. Timepoint: At weeks 0,12. Method of measurement: Enzymatic method , IU\ Lit.</prim_outcome>
      <prim_outcome>Hepatic steatosis. Timepoint: Before intervention and three months intervention. Method of measurement: Ultrasonography.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: At weeks 0 ,12. Method of measurement: Mercury sphygmomanometer, mmhg.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: At weeks 0, 12. Method of measurement: Mercury sphygmomanometer, mmhg.</prim_outcome>
      <prim_outcome>Height. Timepoint: Before intervention. Method of measurement: Stadiometer, mm.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: At weeks 0 ,12. Method of measurement: Weight(kg)\[height(m)]2 , kg\m2.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-26</approval_date>
        <contact_name>Urmia University of Medical Sciences</contact_name>
        <contact_address>Urmia University of Medical Sciences,orjans valley, Resalat boulevard Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
