<?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>IRCT20181017041366N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-19</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of soybean flour on the glycemic index, glycemic load and  satiety index of white bread</public_title>
      <acronym></acronym>
      <scientific_title>The effect of soybean flour on the glycemic index, glycemic load and  satiety index of white bread in healthy subjects</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34599</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: glycemic index in healthy people. Condition 2: glycemic load in healthy people. Condition 3: Satiety index in healthy people.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Each individual will consume a bread made of white wheat flour, water, improver, salt and yeast. This bread should contain 50 grams of available carbohydrates and 1,000 Kilojoules (240 kilocalories) of energy. Intervention 2: Intervention group 2: Each individual will consume a bread made of a mixture of equal amounts of soybean flour and white flour, water, improver, salt and dough. This bread should contain 50 grams of available carbohydrates and 1,000 Kilojoules (240 kilocalories) of energy. Intervention 3: Intervention group 3: Each individual will consume a bread made of a mixture of 25% soybean flour and 75% white flour, water, improver, salt and dough. This bread should contain 50 grams of available carbohydrates and 1,000 Kilojoules (240 kilocalories) of energy. Intervention 4: Control group: Glucose solution (50 g dissolved in 250 ml of water) used to determine the glycemic index as a reference food.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somayeh Mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Building Co-operation of Municipalities, Baharestan 29, Ashoori Street, Bushehr,</address>
        <city>Boushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7515799999</zip>
        <telephone>+98 77 3355 7288</telephone>
        <email>somayeh.mirzaei48@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farideh Shishehbor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3373 8317</telephone>
        <email>shishehbor.f@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The level of fasting blood glucose is normal (less than 110 mg / ml)
Body mass index  normal (18.5 to 24.9)
Follow the normal diet</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking medications that affect the metabolism of blood sugar and the amount of hunger and satiety.
Diseases that affect the metabolism of blood sugar and the amount of hunger and satiety.
Pregnancy
Lactation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: Each individual will consume a bread made of white wheat flour, water, improver, salt and yeast. This bread should contain 50 grams of available carbohydrates and 1,000 Kilojoules (240 kilocalories) of energy.</i_keyword>
      <i_keyword>Intervention group 2: Each individual will consume a bread made of a mixture of equal amounts of soybean flour and white flour, water, improver, salt and dough. This bread should contain 50 grams of available carbohydrates and 1,000 Kilojoules (240 kilocalories) of energy.</i_keyword>
      <i_keyword>Intervention group 3: Each individual will consume a bread made of a mixture of 25% soybean flour and 75% white flour, water, improver, salt and dough. This bread should contain 50 grams of available carbohydrates and 1,000 Kilojoules (240 kilocalories) of energy.</i_keyword>
      <i_keyword>Control group: Glucose solution (50 g dissolved in 250 ml of water) used to determine the glycemic index as a reference food.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Satiety index. Timepoint: Measure satiety in fasting and every 15 minutes after eating each bread for up to two hours in the first week, the second week and the third week. Method of measurement: Using the visual analog scale questionnaire and formula.</prim_outcome>
      <prim_outcome>Glycemic index. Timepoint: Blood glucose measurements in fasting state and15، 30، 45، 60، 90، and 120 minutes after eating. Method of measurement: Using formula.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Glycemic load. Timepoint: First week, second week, third week. Method of measurement: Using formula.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-14</approval_date>
        <contact_name>Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
