<?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>IRCT201111272709N23</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-12-24</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The Effects of cranberry juice in type 2 diabetic male patients.</public_title>
      <acronym></acronym>
      <scientific_title>The Effects of cranberry juice on serum glucose, apoB, apoA-I, Lp(a) and Paraoxonase-1 activity in type 2 diabetic male patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-08-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2536</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>IV Endocrine, nutritional and metabolic diseases.</hc_freetext>
      <i_freetext>Intervention 1: A double-blind randomized clinical trial of parallel design was used. During a 2-week baseline period, participants continued their usual diet without any cranberry (Run-in period), then in intervention group Patients  consumed 1 cup (240m1) cranberry juice (CJ group)  for 12 weeks.Thirty, nonsmoking type 2 diabetes(T2D) male patients were recruited from the Endocrine Research Center of Tehran University of Medical sciences (TUMS), Tehran, Iran from Sep 2009 to March 2011.All patients were asked to maintain their usual diet and physical activity level and not to alter their lifestyle during the intervention. Twenty-nine patients in intervention group ended the study. Intervention 2: A double-blind randomized clinical trial of parallel design was used. During a 2-week baseline period, participants continued their usual diet without any cranberry (Run-in period), then in control group patients  consumed 1 cup (240m1) placebo drink (natural mineral water with strawberry flavor)  for 12 weeks.Thirty, nonsmoking type 2 diabetes(T2D) male patients were recruited from the Endocrine Research Center of Tehran University of Medical sciences (TUMS), Tehran, Iran from Sep 2009 to March 2011.All patients were asked to maintain their usual diet and physical activity level and not to alter their lifestyle during the intervention. Twenty-nine patients in control group ended 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>Farzad Shidfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Health, No 52, Alvand Avenue, Argantine Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8877 9118</telephone>
        <email>farzadshidfar@yahoo.com</email>
        <affiliation>Tehran University of Medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzad Shidfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Health,No. 52, Alvand Avenue, Argantine Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8877 9118</telephone>
        <email>farzadshidfar@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: BMI more than 30 kg/m2; HbAlc less than 9% ; serum triglyceride &lt; 400mg/d1 ; serum total cholesterol&lt; 240mg/d1; taking oral hypoglycemic agents but not   insulin. &#13;
Exclusion criteria:A recent (within previous 3 months) or past history of symptomatic heart disease ; myocardial infarction ; angina pectoris or stroke ; surgery ; liver ; renal (plasma creatinine &gt;1.62 mg/d1) or thyroid disease; use of steroids or drugs with unknown components ; change in the use of medication for diabetes ; hypertension ; dyslipidemia or anti-platelet in the previous 2 months ; pregnancy or  reastfeeding.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>70 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E(E00-E90)</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>E11</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>A double-blind randomized clinical trial of parallel design was used. During a 2-week baseline period, participants continued their usual diet without any cranberry (Run-in period), then in intervention group Patients  consumed 1 cup (240m1) cranberry juice (CJ group)  for 12 weeks.Thirty, nonsmoking type 2 diabetes(T2D) male patients were recruited from the Endocrine Research Center of Tehran University of Medical sciences (TUMS), Tehran, Iran from Sep 2009 to March 2011.All patients were asked to maintain their usual diet and physical activity level and not to alter their lifestyle during the intervention. Twenty-nine patients in intervention group ended the study.</i_keyword>
      <i_keyword>A double-blind randomized clinical trial of parallel design was used. During a 2-week baseline period, participants continued their usual diet without any cranberry (Run-in period), then in control group patients  consumed 1 cup (240m1) placebo drink (natural mineral water with strawberry flavor)  for 12 weeks.Thirty, nonsmoking type 2 diabetes(T2D) male patients were recruited from the Endocrine Research Center of Tehran University of Medical sciences (TUMS), Tehran, Iran from Sep 2009 to March 2011.All patients were asked to maintain their usual diet and physical activity level and not to alter their lifestyle during the intervention. Twenty-nine patients in control group ended the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lp(a). Timepoint: 12 weeks. Method of measurement: Laboratory kits.</prim_outcome>
      <prim_outcome>Glucose. Timepoint: 12 weeks. Method of measurement: laboratory kits.</prim_outcome>
      <prim_outcome>Paraoxonase-1. Timepoint: 12 weeks. Method of measurement: Laboratory kits.</prim_outcome>
      <prim_outcome>ApoB. Timepoint: 12 weeks. Method of measurement: laboratory kits.</prim_outcome>
      <prim_outcome>Apoa-I. Timepoint: 12 weeks. Method of measurement: laboratory kits.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: 12 weeks. Method of measurement: electronic scale.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: 12 weeks. Method of measurement: Weight/height2.</sec_outcome>
      <sec_outcome>Waist circumference. Timepoint: 12 weeks. Method of measurement: nonstrechable tape.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-01-18</approval_date>
        <contact_name>School of Medicine,Tehran University of Medical sciencesa</contact_name>
        <contact_address>Central building of Tehran University of Medical Sciences,  Intersection of Qods Avenue and Bulvard Keshavarz Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
