<?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>IRCT20170206032417N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-18</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Effect of type oil in treatment of Metabolic syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effect of replacing clarified butter with canola oil on Metabolic Syndrome components, fatty liver index, and  insulin resistance in patients with Metabolic Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69862</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Metabolic syndrome.</hc_freetext>
      <i_freetext>Initially, individuals will be selected who consume ghee or clarified butter for cooking, with a daily consumption of 3 to 8 units of this oil. In addition to the usual treatment, all individuals will be advised to switch to the same amount of canola oil they used for cooking. To ensure uniform consumption of other food groups in individuals, everyone will be advised to follow the Food and Agriculture Organization (FAO) recommendations for Iranians. All participants will be asked not to change their physical activity and medication during the study. The dosage of medications (vitamin E and pioglitazone) will be the same for all individuals from the beginning to the end of the study. To ensure compliance with recommendations and to examine food groups and physical activity during the study, a 24-hour recall questionnaire will be completed for three days (two non-holiday days and one holiday) and a physical activity questionnaire before the start of the study and at the end of each month during the study, totaling 12 questionnaires for the dietary recall and 4 days for the physical activity questionnaire during the study. Also, patients will be contacted by phone every week and necessary reminders will be given. The counseling program for patients will include one in-person counseling session, provision of educational materials, and relevant text messages. The duration of intervention is 12 weeks..</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Alizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutrition, School of Medicine, Urmia University of Medical Science, 11th km of Nazloo Highway, Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715799313</zip>
        <telephone>+98 44 3275 2375</telephone>
        <email>alizadeh.m@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Alizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutrition, School of Medicine, Urmia University of Medical Science, 11th km of Nazloo Highway, Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5315799313</zip>
        <telephone>+98 44 3275 2375</telephone>
        <email>alizadeh.m@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having metabolic syndrome according to International Diabetes Federation (IDF) guideline
Age range from 35 to 65 years
Daily clarified butter/ghee consumption of 3 to 8 servings</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Renal disease
Heart failure
Having various type of cancer
Psychotic disorders
Pregnancy and lactation during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E88.81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>سندرم متابولیک</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Initially, individuals will be selected who consume ghee or clarified butter for cooking, with a daily consumption of 3 to 8 units of this oil. In addition to the usual treatment, all individuals will be advised to switch to the same amount of canola oil they used for cooking. To ensure uniform consumption of other food groups in individuals, everyone will be advised to follow the Food and Agriculture Organization (FAO) recommendations for Iranians. All participants will be asked not to change their physical activity and medication during the study. The dosage of medications (vitamin E and pioglitazone) will be the same for all individuals from the beginning to the end of the study. To ensure compliance with recommendations and to examine food groups and physical activity during the study, a 24-hour recall questionnaire will be completed for three days (two non-holiday days and one holiday) and a physical activity questionnaire before the start of the study and at the end of each month during the study, totaling 12 questionnaires for the dietary recall and 4 days for the physical activity questionnaire during the study. Also, patients will be contacted by phone every week and necessary reminders will be given. The counseling program for patients will include one in-person counseling session, provision of educational materials, and relevant text messages. The duration of intervention is 12 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: Measurement of fasting blood sugar at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption. Method of measurement: Enzymatic method, IU/ Lit.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: Measurement of waist circumference at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption. Method of measurement: Meter, Cm.</prim_outcome>
      <prim_outcome>HDL cholesterol. Timepoint: Measurement of HDL cholesterol at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption. Method of measurement: Enzymatic method, mg/dl.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Measurement of Triglyceride at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption. Method of measurement: Enzymatic method, mg/dl.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Measurement of Systolic blood pressure at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption. Method of measurement: Sphygmomanometer, mm Hg.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: Measurement of Diastolic blood pressure at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption. Method of measurement: Sphygmomanometer, mm Hg.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: Measurement of weight at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption. Method of measurement: Scale. kg.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: Measurement of BMI at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption. Method of measurement: Weight(kg)/[height(m)]2 , kg/m2.</sec_outcome>
      <sec_outcome>Gamma Glutamyl transferase. Timepoint: Measurement of GGT at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption. Method of measurement: Enzymatic method , IU/ Lit.</sec_outcome>
      <sec_outcome>Serum insulin. Timepoint: Measurement of Serum insulin at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption. Method of measurement: Radioimmunoassay.</sec_outcome>
      <sec_outcome>Low-density lipoprotein cholesterol. Timepoint: Measurement of LDL at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption. Method of measurement: Enzymatic method, mg/dl.</sec_outcome>
      <sec_outcome>Total cholesterol. Timepoint: Measurement of Total cholesterol at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption. Method of measurement: Enzymatic method, mg/dl.</sec_outcome>
      <sec_outcome>Homeostasis model assessment-insulin resistance. Timepoint: Measurement of HOMA-IR at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption. Method of measurement: HOMA-IR = [ (Fasting Serum Glucose, mmol/L) × Fasting Serum Insulin, μIU/mL) ] / 22.5.</sec_outcome>
      <sec_outcome>Height. Timepoint: Measurement of Height at the beginning of the study (before the intervention). Method of measurement: Stadiometer- cm.</sec_outcome>
      <sec_outcome>Quantitative insulin sensitivity check index. Timepoint: Measurement of QUICKI at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption. Method of measurement: QUICKI =[ 1 / (log(Fasting Insulin) + log(Fasting Glucose))].</sec_outcome>
      <sec_outcome>Fatty liver index. Timepoint: Measurement of FLI at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption. Method of measurement: FLI= [e0.953 × loge (TC) + 0.139 × BMI + 0.718 × loge (GGT) + 0.053 × WC - 15.745] ÷ 1+ [e0.953 × loge (TC) + 0.139 × BMI + 0.718 × loge (GGT) + 0.053 × WC - 15.745] × 100.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-15</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Orjhans Street, Resalat Blvd, Urmia University of Medical Sciences Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
