<?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>IRCT2016052928151N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-15</date_registration>
      <primary_sponsor>Vice chancellor for research, Fasa University of Medical Sciences</primary_sponsor>
      <public_title>The effects of decaffeinated green coffee on  type II diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effects of green decaffeinated coffee bean extract on type 2 diabetes mellitus: a randomized, double‐blind, placebo-controlled crossover trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22897</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Other design features: Random allocation will be done by using a table of random numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type II Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Each Capsule contains 800 mg of decaffeinated green coffee extract and 50 percent chlorogenic acid . Two Capsules daily, one a half hour before breakfast and another a half hour before lunch with a full glass of water. Intervention 2: Control group: Each Capsule contains 800 mg of celloluse. Two Capsules daily, one a half hour before breakfast and another a half hour before lunch with a full glass of water.</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 Roshanzamir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn sina square, Fasa University of Medical Sciences</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 5331 6300</telephone>
        <email>farzad.roshanzamer@yahoo.com; froshanzamer@gmail.com; farzadroshanzam@mail.mui.ac.ir</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Moeteza Safavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jarib St.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 3168</telephone>
        <email>safavimorteza@nutri.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: diagnosis of type II diabetes during the last two years, aged 45 to 60 years, no weight loss during the last 6 months (less than 1 kg), avoiding the use of tobacco and alcohol Exclusion criteria: any change in medications or supplements, pregnancy, chronic kidney and liver disease, neuromuscular disease, failure to follow the prescribed diet (if food records during the study show the energy intake of 300 calories less or more than the amount specified).</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-insulin-dependent diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Each Capsule contains 800 mg of decaffeinated green coffee extract and 50 percent chlorogenic acid . Two Capsules daily, one a half hour before breakfast and another a half hour before lunch with a full glass of water.</i_keyword>
      <i_keyword>Control group: Each Capsule contains 800 mg of celloluse. Two Capsules daily, one a half hour before breakfast and another a half hour before lunch with a full glass of water.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>2HPP. Timepoint: Beginning and end of each phase. Method of measurement: Biochemical auto analyzer colorimetric method.</prim_outcome>
      <prim_outcome>FBS. Timepoint: Beginning and end of each phase. Method of measurement: Biochemical auto analyzer colorimetric method.</prim_outcome>
      <prim_outcome>Weight. Timepoint: Beginning and end of each phase. Method of measurement: Carriage scales.</prim_outcome>
      <prim_outcome>Fetuin-A. Timepoint: Beginning and end of each phase. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>TG. Timepoint: Beginning and end of each phase. Method of measurement: Biochemical auto analyzer colorimetric method.</prim_outcome>
      <prim_outcome>Chol. Timepoint: Beginning and end of each phase. Method of measurement: Biochemical auto analyzer colorimetric method.</prim_outcome>
      <prim_outcome>LDL. Timepoint: Beginning and end of each phase. Method of measurement: Biochemical auto analyzer colorimetric method.</prim_outcome>
      <prim_outcome>HDL. Timepoint: Beginning and end of each phase. Method of measurement: Biochemical auto analyzer colorimetric method.</prim_outcome>
      <prim_outcome>Insolin. Timepoint: Beginning and end of each phase. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>HOMA-IR. Timepoint: Beginning and end of each phase. Method of measurement: Formola.</prim_outcome>
      <prim_outcome>GOT. Timepoint: Beginning and end of each phase. Method of measurement: Biochemical auto analyzer colorimetric method.</prim_outcome>
      <prim_outcome>GPT. Timepoint: Beginning and end of each phase. Method of measurement: Biochemical auto analyzer colorimetric method.</prim_outcome>
      <prim_outcome>ALK. Timepoint: Beginning and end of each phase. Method of measurement: Biochemical auto analyzer colorimetric method.</prim_outcome>
      <prim_outcome>Pr. Timepoint: Beginning and end of each phase. Method of measurement: Biochemical auto analyzer colorimetric method.</prim_outcome>
      <prim_outcome>ALB. Timepoint: Beginning and end of each phase. Method of measurement: Biochemical auto analyzer colorimetric method.</prim_outcome>
      <prim_outcome>Total billirobin. Timepoint: Beginning and end of each phase. Method of measurement: Biochemical auto analyzer colorimetric method.</prim_outcome>
      <prim_outcome>Direct billirobin. Timepoint: Beginning and end of each phase. Method of measurement: Biochemical auto analyzer colorimetric method.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Beginning and end of each phase. Method of measurement: manometer.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: Beginning and end of each phase. Method of measurement: Meter.</prim_outcome>
      <prim_outcome>Polyphenols. Timepoint: Beginning, Middle and end of each phase. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>HbA1C. Timepoint: Beginning and end of each phase. Method of measurement: Biochemical auto analyzer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Vice chancellor for research, Isfahan University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor for research, Fasa University of Medical Sciences</source_name>
      <source_name>Vice chancellor for research, Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-26</approval_date>
        <contact_name>Ethics committee of Fasa University of Medical Sciences</contact_name>
        <contact_address>Ibn sina square,  Fasa University of Medical Sciences Fasa  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Ethics committee of Fasa University of Medical Sciences</contact_name>
        <contact_address>Ebe sina Square, Fasa University of Medical Sciences Fasa  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-19</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jarib St. Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
