<?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>IRCT2013021112429N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-05-21</date_registration>
      <primary_sponsor>Department of Research and Technology, Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Effect  of cumin on  blood fat and  body composition in obese women</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of  Cumin on Lipid profile and and  body composition in overweight and obese women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-01-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12484</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: hyperlipidaemia. Condition 2: OBESITY.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group, will be asked  to eat 3 grams cumin powder with  yogurt for lunch and dinner, two times (each time 1/5  grams cumin + 150 ml low-fat yogurt.) Reduced calorie diet (300 kcal less than the amount necessary) to be given by a Nutrition Specialist. Intervention 2: in control group:    reduced calorie diet (300 kcal less than the amount necessary) to be given by a nutrition Specialist.they asked to eat 150 ml low-fat yogurt ,twice a they with out cumin.Period of study was 3 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>Roghayeh Zare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition and Food Security Research Centre , University of Health , Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 1624 0691</telephone>
        <email>R_ZARE1391@SSU.AC.IR</email>
        <affiliation>Nutrition and Food Security Research Centre</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roghayeh Zare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutrition , University of Health , Imam Reza Research Center, Yazd</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 1624 0691</telephone>
        <email>R_ZARE1391@SSU,AC.IRz_roghayeh@yahoo.com</email>
        <affiliation>Nutrition and Food Security Research Center, University of Health</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: women with BMI 25-40; consent to participate in the study ;No previous treatment regimen for three months before entering the study; no change in weight over 2 kg in a month prior to entering the  study; lack of sensitivity to the Cumin, non-infectious diseases, diabetes, hypertension, thyroid disease and other chronic diseases based on self-declaration ; age 20-60 years&#13;
Exclusion criteria: failure to cooperate in the study; the history of the program regimen; change in weight over 2 kg in the last month; allergic reactions of cumin; Disease during the study, or a history of chronic disease</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E78</hc_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders of lipoprotein metabolism</hc_keyword>
      <hc_keyword>Simple obesity NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group, will be asked  to eat 3 grams cumin powder with  yogurt for lunch and dinner, two times (each time 1/5  grams cumin + 150 ml low-fat yogurt.) Reduced calorie diet (300 kcal less than the amount necessary) to be given by a Nutrition Specialist</i_keyword>
      <i_keyword>in control group:    reduced calorie diet (300 kcal less than the amount necessary) to be given by a nutrition Specialist.they asked to eat 150 ml low-fat yogurt ,twice a they with out cumin.Period of study was 3 months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fbs. Timepoint: 3 month. Method of measurement: blood sample.</prim_outcome>
      <prim_outcome>Bmi. Timepoint: 3 month. Method of measurement: w/h2.</prim_outcome>
      <prim_outcome>Tg. Timepoint: 3 month. Method of measurement: blood sample.</prim_outcome>
      <prim_outcome>Col. Timepoint: 3month. Method of measurement: blood sample.</prim_outcome>
      <prim_outcome>LDL-C. Timepoint: 3 month. Method of measurement: blood sample.</prim_outcome>
      <prim_outcome>HDL-C. Timepoint: 3 month. Method of measurement: blood sample.</prim_outcome>
      <prim_outcome>LDL/HDL. Timepoint: 3 month. Method of measurement: blood sample.</prim_outcome>
      <prim_outcome>COL/HDL. Timepoint: 3 month. Method of measurement: blood sample.</prim_outcome>
      <prim_outcome>VLDL. Timepoint: 3 month. Method of measurement: blood sample.</prim_outcome>
      <prim_outcome>Weight. Timepoint: every month until 3 month. Method of measurement: .</prim_outcome>
      <prim_outcome>Waist size. Timepoint: 3 month. Method of measurement: cm.</prim_outcome>
      <prim_outcome>Fat mass. Timepoint: 3 month. Method of measurement: body composition analizer.</prim_outcome>
      <prim_outcome>Free body mascle. Timepoint: 3 month. Method of measurement: body composition analizer.</prim_outcome>
      <prim_outcome>Percent of fat mass. Timepoint: 3 month. Method of measurement: body composition analizer.</prim_outcome>
      <prim_outcome>Percent of free  mascle mass. Timepoint: 3 month. Method of measurement: body composition analizer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Department of Research and Technology, Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-01-23</approval_date>
        <contact_name>Yazd University of Medical Sciences</contact_name>
        <contact_address>Bahonar Square, Yazd Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
