<?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>IRCT2015071323195N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-10-22</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences International Campus, School of Nutritional Science and Diteti</primary_sponsor>
      <public_title>the effect of calorie restriction with medium fiber diet in obese and overweight type 2 diabetic patients</public_title>
      <acronym>apoa2=apolipoprotein a2</acronym>
      <scientific_title>clinical trial of calorie restriction with medium fiber diet on serum levels of some inflammatory factors and their gene expression in obese and overweight type 2 diabetic patients with CC and TT/TC polymorphism in APOA-II and comparison of changes in these genotypes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19828</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: non-insulin-dependent diabetes. Condition 2: obesity.</hc_freetext>
      <i_freetext>During a 6-week patients will receive low-energy diet and moderate fiber (30 grams per day) including 55 to 65% carbohydrates, 20% protein and 25% fat. To get enough fiber in addition to increasing the consumption of fruits and vegetables will add wheat bran to the diet and to ensure the same type of bran consumption the required amount will be available to them every two weeks.&#13;
After calculating the amount of energy needed for daily, diets will be set for each individual. 21 food menu with identified calorie will prepare for each personand every two weeks we will give them 7 menu with same calorie to the individuals which give them the power to choose the desired menu and even have a repeat in the week. And they also share the same energy that allows people to use between meals, such as breakfast menu to choose their favorite.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number 44, Hojatdust Avenue, Naderi Street, Keshavarz Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 4473 3292</telephone>
        <email>moradi_ma@yahoo.com;m_moradi@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences, School of Nutritional Science and Ditetics</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Fariba Koohdani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number 44, Hojatdust avenue, Naderi Street, Keshavarz Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8895 5569</telephone>
        <email>fkoohdan@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences, School of Nutritional Science and Ditetics</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age between 45-65 years; BMI more than or equal 27; type 2 diabetes who do not inject insulin&#13;
Exclusion criteria: compliance of dietary recommendations less than 80%; Acute inflammatory diseases in the last 3 days before blood sampling; receiving antiinflammatory medications and multivitamin mineral supplements during the intervention</inclusion_criteria>
      <agemin>49 years</agemin>
      <agemax>29 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-insulin-dependent diabetes mellitus</hc_keyword>
      <hc_keyword>Obesity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>During a 6-week patients will receive low-energy diet and moderate fiber (30 grams per day) including 55 to 65% carbohydrates, 20% protein and 25% fat. To get enough fiber in addition to increasing the consumption of fruits and vegetables will add wheat bran to the diet and to ensure the same type of bran consumption the required amount will be available to them every two weeks.&#13;
After calculating the amount of energy needed for daily, diets will be set for each individual. 21 food menu with identified calorie will prepare for each personand every two weeks we will give them 7 menu with same calorie to the individuals which give them the power to choose the desired menu and even have a repeat in the week. And they also share the same energy that allows people to use between meals, such as breakfast menu to choose their favorite</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Paraoxonase 1 enzyme. Timepoint: before and after intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Activity of LCAT enzyme. Timepoint: before and after intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Serum TNF-α. Timepoint: before and after intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>VCAM1, ICAM1, PTX3 gene expression. Timepoint: before and after intervention. Method of measurement: Real-Time PCR.</prim_outcome>
      <prim_outcome>Paraoxonase3 enzyme. Timepoint: before and after intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Serum NFKB. Timepoint: before and after intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Serum ICAM1. Timepoint: before and after intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Serum VCAM1. Timepoint: before and after intervention. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Serum HDL2 and HDL3. Timepoint: before and after intervention. Method of measurement: kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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>Tehran University of Medical Sciences International Campus, School of Nutritional Science and Diteti</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-09-21</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Poorsina Avenue, Ghods Street, Keshavarz Blvd. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
