<?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>IRCT20180305038966N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-29</date_registration>
      <primary_sponsor>Kashani Hospital</primary_sponsor>
      <public_title>Study of the Effect of bread containing flaxseed on serum  level of Apelin and lipid profile in hyperlipidemic patients</public_title>
      <acronym></acronym>
      <scientific_title>Study of the Effect of bread containing flaxseed on serum level of Apelin and lipid profile in hyperlipidemic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29989</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 48 patients are randomly assigned to two equal groups (lottery) of intervention and placebo, Blinding description: Researchers and patients are unaware of the type of bread they are being divided.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hyperlipidemia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: intake 2 unit of bread containing 20 gram of flax seed  flour and 80 gram of wheat flour for 6 weeks and twice a day. Intervention 2: Control group: intake 2 unit of simple bread containing 100 gram of wheat flour for 6 weeks and twice a day.</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 will not be able to make decisions about the details of the publication at the beginning</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Shakeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Hesarak B lvd , University square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 4486 1815</telephone>
        <email>nutrition@mail.mui.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hasan Entezari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib Ave, Isfahan University of MedicalSciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 2775</telephone>
        <email>entezari@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>high is one of the lipid factors: cholesterol is grater than or equal to 200.triglycerides grater or equal. LDL is grater or equal 130 and rate of HDL is less than 40 for men and 50 mg per deciliter for women(high levels of LDL or cholesterol are essential
Men and wemen 20-50 years old
Patients who agree to participate in the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Tobacco use
Adherence to a particular diet
Consumption bread of flaxseed in the last 6 months
Pregnancy, breast feeding, menopause</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E78</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders of lipoprotein metabolism and other lipidemias</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: intake 2 unit of bread containing 20 gram of flax seed  flour and 80 gram of wheat flour for 6 weeks and twice a day</i_keyword>
      <i_keyword>Control group: intake 2 unit of simple bread containing 100 gram of wheat flour for 6 weeks and twice a day</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum level of LDL. Timepoint: At the beginning of the study and the end of the sixth week. Method of measurement: By enzyme _ mg/dl.</prim_outcome>
      <prim_outcome>Serum level of total cholesterol. Timepoint: At the beginning of the study and the end of the sixth week. Method of measurement: By enzyme _ mg/dl.</prim_outcome>
      <prim_outcome>Serum level of Apelin. Timepoint: At the beginning of the study and the end of the sixth week. Method of measurement: Eliza_ picogram/ml.</prim_outcome>
      <prim_outcome>Serum level of triglyceride. Timepoint: At the beginning of the study and the end of the sixth week. Method of measurement: By enzyme _ mg/dl.</prim_outcome>
      <prim_outcome>Serum level of HDL. Timepoint: At the beginning of the study and the end of the sixth week. Method of measurement: By enzyme _ mg/dl.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: At the beginning of the study and the end of the sixth week. Method of measurement: Digital Manometer mmHg.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: At the beginning of the study and the end of the sixth week. Method of measurement: Formula weight/High2.</prim_outcome>
      <prim_outcome>Physical activity. Timepoint: Initially, the middle and end of the sixth week study. Method of measurement: Met questionnaire.</prim_outcome>
      <prim_outcome>Food intake. Timepoint: Initially, the middle and end of the sixth week study. Method of measurement: Food frequency questionnaire 3 days.</prim_outcome>
      <prim_outcome>Waist. Timepoint: At the beginning of the study and the end of the sixth week. Method of measurement: Strip Meter- centimeters.</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>Kashani Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-19</approval_date>
        <contact_name>Ethics committee of Science and Research Tehran</contact_name>
        <contact_address>Shahid hesarak Bivd, university Square Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
