<?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>IRCT20190625044008N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-19</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Ѡ3 fatty acids supplementation in elite male athletes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Ѡ3 fatty acids supplementation on levels of PPARγ and UCP2 genes expression, serum level of UCP2 protein, metabolic status, and appetite in elite male athletes: a randomized control trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43332</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: From among the volunteers to participate in the study, 36 individuals will be selected by simple randomization. Then by using the Random Allocation Software, the subjects will be allocated into either fatty Acid Supplements Ѡ3 or placebo group, Blinding description: In this study, the main researchers (including students, tutors, and advisors) as well as the participants will be unaware of the type of supplement (fatty acid supplement 3 or placebo) received by each group. The person responsible for the packaging of supplements that is completely unrelated to the study will be required to assign a three-digit code to each package and keep the codes until the end of the study and analysis of the data.</study_design>
      <phase>N/A</phase>
      <hc_freetext>.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: soft gel supplement fatty acid Ѡ3 daily 2 soft gel, dose of 1 g with lunch and dinner for 3 weeks. Intervention 2: Control group: soft gel placebo (paraffin) daily 2 soft gel, dose of 1 g with lunch and dinner for 3 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 It has not yet been decided to publish various sections on the consequences in the relevant journals.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Attar-e Nishaboori ST- Faculty of Nutrition and Food Sciences</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5183874384</zip>
        <telephone>+98 41 3441 5282</telephone>
        <email>saramoradi678@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Beit Allah Alipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Attar-e Nishaboori ST, Faculty of Nutrition and Food Sciences</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5183874384</zip>
        <telephone>+98 41 3335 7584</telephone>
        <email>alipourb@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No history of chronic and/or blood coagulation diseases
Range of BMI of 18.5 to 25 kg / m 2
Willingness to participate in the study
Age 20– 30 years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Received Ѡ3 fatty acids supplements in last month</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>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: soft gel supplement fatty acid Ѡ3 daily 2 soft gel, dose of 1 g with lunch and dinner for 3 weeks</i_keyword>
      <i_keyword>Control group: soft gel placebo (paraffin) daily 2 soft gel, dose of 1 g with lunch and dinner for 3 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anthropometric measures. Timepoint: Baseline and 3 weeks after intervention. Method of measurement: Measurement of height and weight without shoes and with minimum clothes on, by Seca stadiometer and scale, respectively. Calculation of body mass index (BMI) by dividing weight (Kg) by height squared (m2).</prim_outcome>
      <prim_outcome>Body composition. Timepoint: Baseline and 3 weeks after intervention. Method of measurement: Bioelectrical Impedance Analysis (BIA) to determine Fat mass (FM), Fat free mass (FFM), and Body water (BW).</prim_outcome>
      <prim_outcome>Resting metabolic rate. Timepoint: Baseline and 3 weeks after intervention. Method of measurement: Indirect calorimetry.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Baseline and 3 weeks after intervention. Method of measurement: Stethoscope.</prim_outcome>
      <prim_outcome>Appetite status. Timepoint: Baseline and 3 weeks after intervention. Method of measurement: Visual analogue scale.</prim_outcome>
      <prim_outcome>Serum UCP2 protein level. Timepoint: Baseline and 3 weeks after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Uncoupling protein2 gene expression. Timepoint: Baseline and 3 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (PCR).</prim_outcome>
      <prim_outcome>Peroxisome proliferator-activated receptors gamma gene expression. Timepoint: Baseline and 3 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (PCR).</prim_outcome>
      <prim_outcome>Serum triglycerides. Timepoint: Baseline and 3 weeks after intervention. Method of measurement: Autoanalyzer kit.</prim_outcome>
      <prim_outcome>Serum low density lipoprotein cholesterol. Timepoint: Baseline and 3 weeks after intervention. Method of measurement: Calculation of LDL-cholesterol by Friedewald equation.</prim_outcome>
      <prim_outcome>Serum high density lipoprotein cholesterol. Timepoint: Baseline and 3 weeks after intervention. Method of measurement: Autoanalyzer kit.</prim_outcome>
      <prim_outcome>Total cholesterol. Timepoint: Baseline and 3 weeks after intervention. Method of measurement: Autoanalyzer kit.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-30</approval_date>
        <contact_name>The Research Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Attar Neyshabouri Av., Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
