<?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>IRCT201111155543N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-02-18</date_registration>
      <primary_sponsor>Qom University of Medical Sciences</primary_sponsor>
      <public_title>The effect of pistachio consumption on laboratory parameters in patients with type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of crude pistachio consumption on lipid parameters, glucose blood level, inflammatory and Oxidative Stress factors in with type 2 diabetes.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5946</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>diabetes.</hc_freetext>
      <i_freetext>Intervention 1: From experimental  group patients will be asked to not change the usual diet, physical activity and lifestyle habits during the study and in their daily snack (morning and Evening) ) are used from 50 grams of raw pistachio without the skin for 8 weeks. Intervention 2: From experimental  group patients will be asked to not change the usual diet, physical activity and lifestyle habits during the study.</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>Saeide Heidari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School Nursing and Midwifery, Lavasani St., Qom</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 25 1770 4233</telephone>
        <email>heidari_saeide@yahoo.com-  sheidari@muq.ac.ir</email>
        <affiliation>Qom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeide Heidari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School Nursing and Midwifery, Lavasani St., Qom</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 25 1770 4233</telephone>
        <email>heidari_saeide@yahoo.com&#13;
sheidari@muq.ac.ir</email>
        <affiliation>Qom university of medical science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Exclusion criteria: patients with kidney, liver and respiratory therapy, history of allergy to pistachio, smoking and alcohol consumption, female patients undergoing hormone therapy, patients treated with insulin, becoming exposed to severe stress (infections, diabetic foot surgery, severe emotional stress), depression and recreational drug use, risk of kidney stones &#13;
inclusion criteria: diabetes, according to physician, willingness to participate in the study, awareness to time and place, not being addiction  to Narcotics and recreational drugs, the ability to speak and understand Persian.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10-E14</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>From experimental  group patients will be asked to not change the usual diet, physical activity and lifestyle habits during the study and in their daily snack (morning and Evening) ) are used from 50 grams of raw pistachio without the skin for 8 weeks.</i_keyword>
      <i_keyword>From experimental  group patients will be asked to not change the usual diet, physical activity and lifestyle habits during the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting Blood Sugar. Timepoint: Before the intervention, 8 weeks after the intervention, two weeks after the intervention, 10 weeks after intervention. Method of measurement: blood test (Mg per deciliter).</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Before the intervention, 8 weeks after the intervention, two weeks after the intervention, 10 weeks after intervention. Method of measurement: blood test (Mg per deciliter).</prim_outcome>
      <prim_outcome>Low-density lipoprotein (LDL). Timepoint: Before the intervention, 8 weeks after the intervention, two weeks after the intervention, 10 weeks after intervention. Method of measurement: blood test (Mg per deciliter).</prim_outcome>
      <prim_outcome>High-density lipoprotein (HDL). Timepoint: Before the intervention, 8 weeks after the intervention, two weeks after the intervention, 10 weeks after intervention. Method of measurement: blood test (Mg per deciliter).</prim_outcome>
      <prim_outcome>TOTAL cholesterol. Timepoint: Before the intervention, 8 weeks after the intervention, two weeks after the intervention, 10 weeks after intervention. Method of measurement: blood test (Mg per deciliter).</prim_outcome>
      <prim_outcome>Total antioxidant. Timepoint: Before the intervention, 8 weeks after the intervention, two weeks after the intervention, 10 weeks after intervention. Method of measurement: blood test (pg/ml).</prim_outcome>
      <prim_outcome>C-reactive protein (CRP). Timepoint: Before the intervention, 8 weeks after the intervention, two weeks after the intervention, 10 weeks after intervention. Method of measurement: blood test (Mg per deciliter).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood Pressure. Timepoint: Before the intervention, 8 weeks after the intervention, two weeks after the intervention, 10 weeks after intervention. Method of measurement: Using a barometer (mmHg).</sec_outcome>
      <sec_outcome>Body mass index (BMI). Timepoint: Before the intervention, 8 weeks after the intervention, two weeks after the intervention, 10 weeks after intervention. Method of measurement: Weight in kilograms divided by height in meters squared.</sec_outcome>
      <sec_outcome>Fasting blood insulin level. Timepoint: Before the intervention, 8 weeks after the intervention, two weeks after the intervention, 10 weeks after intervention. Method of measurement: pg/ml.</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>Qom University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Qom University of Medical Sciences</contact_name>
        <contact_address>Qom University of Medical Sciences, Lavasani St., Qom Qom  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
