<?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>IRCT2014052413678N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-08-26</date_registration>
      <primary_sponsor>Urmia University of Medical Science</primary_sponsor>
      <public_title>A Study on the Effect of Conjugated Lionleic Acid Supplementation on	Body Weight loss</public_title>
      <acronym></acronym>
      <scientific_title>A Study on the Effect of Conjugated Lionleic Acid Supplementation on Body Composition, Blood Glucose, Serum Insulin, Serum Leptin and Lipid Profile in Obese Adults (18-45) of both genders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13459</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: After collecting the initial data,The case group will received daily amount of 3 g CLA (three 1000 mg soft gels) Three times a day Before main Meals for 3 Months. Intervention 2: The control group will received a daily amount of1/5 gr placebo (three 500 mg soft gel containing paraffin oil)three times a day before main meals for three months.</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></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Saeed Ghavamzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Medical Science, 11th km of Nazloo Road, Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715799313</zip>
        <telephone>+98 44 3278 0803</telephone>
        <email>Ghavamzadeh@hotmail.comghavamzadeh_s@umsu.ac.ir</email>
        <affiliation>Urmia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>obese adults of both genders (18-45) with a BMI given as 30-34.9 kg/m2؛No weight loss or gain over 2 kg in the recent three months؛the samples should have no record of diabetes؛cariad disorders؛record of angina pectoris, myocardial infarction, cerebral stroke, suffering from renal and hepatic diseases؛ chronic inflammatory diseases؛ thyroid diseases and gastroenterological diseases؛ not consuming hypoglycemic medicines؛ blood-pressure lowering drugs or anti blood presure medicines؛ beta blockers؛ steregene؛ porgesterone؛ not consuming any kinds of supplementations such as antioxidant vitamines؛ minerals؛ Omega 3 and CLA within two months prior to commencement of study؛ smoking؛ using alchoholic drinks؛ no respiratory or joint complications؛ not being pregnant or breastfeeding and having no intention for getting pregnant. Moreover, the samples suffering from specific complications such as epigasteric pains will be exclued from this study؛ The female samples will be excluded from this project in case of pregnancy.</inclusion_criteria>
      <agemin>75 years</agemin>
      <agemax>48 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After collecting the initial data,The case group will received daily amount of 3 g CLA (three 1000 mg soft gels) Three times a day Before main Meals for 3 Months.</i_keyword>
      <i_keyword>The control group will received a daily amount of1/5 gr placebo (three 500 mg soft gel containing paraffin oil)three times a day before main meals for three months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Age. Timepoint: Before Intervention. Method of measurement: Life years from birth based on birth certificate card.</prim_outcome>
      <prim_outcome>Sex. Timepoint: Before Intervention. Method of measurement: with questionnaire.</prim_outcome>
      <prim_outcome>Weight. Timepoint: Before Intervention and three months after Intervention. Method of measurement: Kg/scale.</prim_outcome>
      <prim_outcome>Height. Timepoint: Before Intervention. Method of measurement: Meter/ribor meter.</prim_outcome>
      <prim_outcome>BMI. Timepoint: Before Intervention and three months after Intervention. Method of measurement: Ratio of weight (kg) to height square (m).</prim_outcome>
      <prim_outcome>FM%. Timepoint: Before Intervention and three months after Intervention. Method of measurement: Percentage/Body Analyzer.</prim_outcome>
      <prim_outcome>FFM%. Timepoint: Before Intervention and three months after Intervention. Method of measurement: Percentage/Body Analyzer.</prim_outcome>
      <prim_outcome>FBS. Timepoint: Before Intervention and three months after Intervention. Method of measurement: Mg/dl/enzymatic method.</prim_outcome>
      <prim_outcome>Cholesterol. Timepoint: Before Intervention and three months after Intervention. Method of measurement: Mg/dl/enzymatic method.</prim_outcome>
      <prim_outcome>TG. Timepoint: Before Intervention and three months after Intervention. Method of measurement: Mg/dl/enzymatic method.</prim_outcome>
      <prim_outcome>VLDL. Timepoint: Before Intervention and three months after Intervention. Method of measurement: Mg/dl/enzymatic method.</prim_outcome>
      <prim_outcome>LDL. Timepoint: Before Intervention and three months after Intervention. Method of measurement: Mg/dl/enzymatic method.</prim_outcome>
      <prim_outcome>HDL. Timepoint: Before Intervention and three months after Intervention. Method of measurement: Mg/dl/enzymatic method.</prim_outcome>
      <prim_outcome>Leptin. Timepoint: Before Intervention and three months after Intervention. Method of measurement: Mg/dl /ELIZA.</prim_outcome>
      <prim_outcome>Waist Size. Timepoint: Before Intervention and three months after Intervention. Method of measurement: Cm/ribbon meter.</prim_outcome>
      <prim_outcome>Insulin Resistance. Timepoint: Before Intervention and three months after Intervention. Method of measurement: HOMA-IR  (Homeostasis Model Assessment of Insulin Resistance) is the same resistance to insulin index which is calculated as follows. 405/(dl/mg) fasting glucose concentration* (ml/micro unit) active fasting insulin concentration.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: Before Intervention and three months after Intervention. Method of measurement: Micro unit per ml/ELIZA.</prim_outcome>
      <prim_outcome>Carbohydrate Intake. Timepoint: Before Intervention and three months after Intervention. Method of measurement: gr/day.</prim_outcome>
      <prim_outcome>Protein Intake. Timepoint: Before Intervention and three months after Intervention. Method of measurement: gr/day.</prim_outcome>
      <prim_outcome>Fat Intake. Timepoint: Before Intervention and three months after Intervention. Method of measurement: gr/day.</prim_outcome>
      <prim_outcome>Energy Intake. Timepoint: Before Intervention and three months after Intervention. Method of measurement: kcal/day.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Gastroenterological side effects. Timepoint: During Intervention. Method of measurement: Taking Report.</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>Urmia University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-01-28</approval_date>
        <contact_name>Urmia University of Medical Sciences</contact_name>
        <contact_address>Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia Urmia  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
