<?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>IRCT20100524004010N32</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-07</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Wheat Germ consumption on anthropometric indices, lipid profiles, glycemic status, hepatic enzymes, hepatocyte apoptosis, inflammatory factors, total antioxidant capacity and liver fibrosis in non-alcoholic fatty liver patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Wheat Germ consumption on anthropometric indices, lipid profiles, glycemic status, hepatic enzymes, hepatocyte apoptosis (Cytokeratin-18), inflammatory factors, total antioxidant capacity and liver fibrosis in non-alcoholic fatty liver patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51862</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The first step is to create a random sequence number. For this purpose, we will use a random number generator on Stattrek (https://stattrek.com/statistics/random-number-generator.aspx) for 50 numbers range from 1 to 2 (for example: 2 1 1 1 2 1 2 1 1 2 2 1 1 2 2 2 2 11 1 2 2 1 1 1 2 2..............).Then, we will specify the numbers to the groups for example, 1 will be assigned to the intervention group one (wheat germ), the numbers 2 to the control group. Each number will represent a group according to the defined numbers. With this method, we will have a specific sequence of 50 codes of  1, 2 , which shows the first to fifty people who are going to be entered in the study in each group. We write the codes on a piece of paper and put them in an envelope to use during sampling. Thus, after reviewing the inclusion criteria and if the participants desire, we will enter each person included in the study according to our predetermined list.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Nonalcoholic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: wheat germ. Intervention 2: Control group: bread crumbs.</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 We have not yet decided how to share the final data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azita Hekmatdoost</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619573</zip>
        <telephone>+98 21 2235 7483</telephone>
        <email>a_hekmat2000@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azita Hekmatdoost</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619573</zip>
        <telephone>+98 21 2235 7483</telephone>
        <email>a_hekmat2000@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>General desire to participate in the study
Age 50-30 years
Has evidence of non-alcoholic steatohepatitis and CAP score more than 263
Body mass index (BMI) ≥ 25kg / m2
No history of alcohol consumption Lack of other diseases and chronic and acute liver disorders (hepatitis B, C, etc.), biliary disease, known autoimmune diseases and hereditary disorders affecting the condition of the liver (iron, copper and ... )
No pregnancy or breastfeeding in women
Do not take hepatotoxic drugs such as phenytoin, amoxifen and lithium
Do not take antibiotics for more than a week during or before the study period
Do not consume Milk thistle(Silybum marianum)
Lack of chronic inflammatory disease
No history of cancer
Lack of treatment with anti-inflammatory drugs
Lack of recent weight loss diet
Do not use weight loss drugs (chemical drugs and effective herbal products)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Changes in medications (lipid-lowering drugs, blood sugar control drugs, and blood pressure medications) during the study period
Lack of adherence to the intervention given to patients
Take supplements or substances that change the individual effect  during the intervention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K75.81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nonalcoholic steatohepatitis (NASH)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: wheat germ</i_keyword>
      <i_keyword>Control group: bread crumbs</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hepatic steatosis, Liver fibrosis. Timepoint: At the first and at the 12th week of the study. Method of measurement: fibroscan.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: At the first and 12th week of the study. Method of measurement: Scale.</sec_outcome>
      <sec_outcome>BMI. Timepoint: At the first and 12th week of the study. Method of measurement: Calculate.</sec_outcome>
      <sec_outcome>Liver enzymes (AST,ALT,GGT). Timepoint: At the first and 12th week of the study. Method of measurement: Enzymatic method.</sec_outcome>
      <sec_outcome>Lipid profile (TG,Total cholesterol,LDL-C,HDL-C). Timepoint: At the first and 12th week of the study. Method of measurement: Enzymatic method.</sec_outcome>
      <sec_outcome>Hs-CRP. Timepoint: At the first and 12th week of the study. Method of measurement: ELISA.</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>Research Assistant Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-24</approval_date>
        <contact_name>Ethics Committee of the National Institute of Nutritional Research and Food Industry</contact_name>
        <contact_address>No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
