<?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>IRCT20180305038966N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-18</date_registration>
      <primary_sponsor>Kashani Hospital</primary_sponsor>
      <public_title>Study of the effect of  bread containing flaxseed on patients with metabolic syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Study of the effect of  bread containing flaxseed on patients with metabolic syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32230</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The 48 patients selected are divided into two groups of intervention and placebo. In the present study, a simple randomization method will be used, the randomization unit will be used individually and we will use the random number table method to generate random sequences. A random number table is a massive set of numbers that is generated without a definite pattern and completely randomized. The next step is to hide random assignments and use non-transparent sealed envelopes with random sequences. will be. Then, based on the sample size of the study, a number of envelopes with an aluminum wrapper are prepared and each random sequence created on a card is recorded and the cards are inserted into the envelopes respectively. At the time of the registration of the participants, According to the order of entry of eligible participants of the study, one of the envelopes is opened in sequence and the participant's group is revealed, Blinding description: researchers and patients are unaware of the type of bread they are being divided.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Metabolic syndrome.</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 Iwill 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>Kashani Ave,Kashani hospital</address>
        <city>isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8183983434</zip>
        <telephone>+98 31 3233 0091</telephone>
        <email>nutrition@mail.mui.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>NahidShakeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashani Ave,Kashani Haspital</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8183983434</zip>
        <telephone>+98 31 3233 0091</telephone>
        <email>nutrition@mail.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having 3 Indices of 5 Metabolic Syndrome Indicators. Waist circumference is more than 102 centimeters for men and more than 88 centimeters for women. The level of triglyceride is greater than or equal to 150 mg / dL. HDL cholesterol levels less than 40 for men and less than 50 mg per decilitre for women. The fasting blood sugar level is greater than or equal to 100 mg / dL. The blood pressure is greater than or equal to 130/85 mmHg
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></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</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 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>Serum level of FBS. 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>Waist. Timepoint: At the beginning of the study and the end of the sixth week. Method of measurement: Strip Meter- Centimeters.</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>
    </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>2018-02-18</approval_date>
        <contact_name>Ethics committee Science and Research Tehran</contact_name>
        <contact_address>میدان دانشگاه،  بلوار شهدای حصارک Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
