<?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>IRCT20160702028742N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-05</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>ٍffects of ghee consumption on  plasma lipids in healthy adults</public_title>
      <acronym></acronym>
      <scientific_title>Comparing of the effects of olive oil and ghee consumption on  plasma lipids and lipoproteins, adiponectin, and insulin in healthy adults</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49431</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: Simple randomization method is performed using computer randomization software. For this purpose, in order to randomize whether the consumption of ghee by each person will be first or the second treatment, each person's number will be entered in Excel software and then they are randomized using the RAND function. The first 15 participants will begin study by consuming ghee and the next 15 will begin by consuming the olive oil.</study_design>
      <phase>N/A</phase>
      <hc_freetext>healthy subjects.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Consume ghee in the diet for 4 weeks. The approximate amount of oil allowed for each person to prepare each of the two meals of lunch and dinner is determined and they are asked that the amount of oil needed to cook food in each of the two meals of lunch and dinner is specified in the amount. People are also advised to consume low-fat animal sources (dairy and meat products). Intervention 2: Control group: Consumption of olive oil in the diet. The approximate amount of oil allowed for each person to prepare each of the two meals of lunch and dinner is determined and they are asked that the amount of oil needed to cook food in each of the two meals of lunch and dinner is specified in the amount. People are also advised to consume low-fat animal sources (dairy and meat products).</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>Javand Nasrollahzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, West Arghavan Ave., Farahzadi Blvd., Qods</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619573</zip>
        <telephone>+98 21 2207 7424</telephone>
        <email>jnasrollahzadeh@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Javad Nasrollahzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619573</zip>
        <telephone>+98 21 2207 7424</telephone>
        <email>jnasrollahzadeh@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>I.	Adult male and non-menopausal female aged 20-60 year</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>I.	History of type 2 diabetes
I.	History of coronary heart disease
II.	Abnormal liver function test (ALT and AST &gt; 45 U/L )
III.	Abnormal kidney function test (createnine &gt; 1.4 mg/dL)
IV.	On lipid lowering medication
V.	Pregnancy and breast feeding
VI.	Female on oral contraceptive unless they have no intention to change during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Consume ghee in the diet for 4 weeks. The approximate amount of oil allowed for each person to prepare each of the two meals of lunch and dinner is determined and they are asked that the amount of oil needed to cook food in each of the two meals of lunch and dinner is specified in the amount. People are also advised to consume low-fat animal sources (dairy and meat products).</i_keyword>
      <i_keyword>Control group: Consumption of olive oil in the diet. The approximate amount of oil allowed for each person to prepare each of the two meals of lunch and dinner is determined and they are asked that the amount of oil needed to cook food in each of the two meals of lunch and dinner is specified in the amount. People are also advised to consume low-fat animal sources (dairy and meat products).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Plasma LDL-cholesterol. Timepoint: Measurements at baseline (before the start of the intervention) and 4 weeks after the start. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Plasma apo B levels. Timepoint: Measurements at baseline (before the start of the intervention) and 4 weeks after the start. Method of measurement: Spectrophotometry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Plasma TG. Timepoint: Measurements at baseline and 4 weeks after each intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Plasma  ALT. Timepoint: Measurements at baseline and 4 weeks after each intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Plasma Insulin levels. Timepoint: Measurements at baseline and 4 weeks after each intervention. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Plasma Adiponectin levels. Timepoint: Measurements at baseline and 4 weeks after each intervention. Method of measurement: ELISA.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-01</approval_date>
        <contact_name>National Nutrition and Food Technology Research Institute Ethic Committee</contact_name>
        <contact_address>No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town, Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
