<?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>IRCT20181227042149N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-23</date_registration>
      <primary_sponsor>The University of Sistan and Baluchestan</primary_sponsor>
      <public_title>Effect of physical activity and supplementation on BDNF index</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 6 weeks of high-intensity interval training (HIIT) with supplementation of Omega-3 on serum levels of brain-derived neurotrophic factor (BDNF) in sedentary male students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36366</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple random method, Simple random units (groups) are selected in lottery form, Then all the names of the people are in the envelopes and each of them is selected by lot.</study_design>
      <phase>3</phase>
      <hc_freetext>healthy people.</hc_freetext>
      <i_freetext>Intervention 1: Control group: During this 6-week period, no activity will be involved, nor will any use be made. Intervention 2: First Intervention group: High-Intensity interval training (40 m round trip speed for 6 weeks,  4 repetitions in the first week and 8 repetitions in the sixth week). Along with taking 2 grams of omega-3 jelly capsules made by Zahravi Iran Co. at breakfast and dinner1 gram plus one glass of water for 6 weeks. Intervention 3: Second Intervention group: High-Intensity interval training (40 m round trip speed for 6 weeks,  4 repetitions in the first week and 8 repetitions in the sixth week). Intervention 4: Third Intervention group: with taking 2 grams of omega-3 jelly capsules made by Zahravi Iran Co. at breakfast and dinner1 gram plus one glass of water for 6 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Total data

When:
6 months after the results are published

To whom:
Researchers working in academic institutions and scientific, People working in medicine and industry

Conditions:
For future research and any kind of analysis is allowed.

Where to obtain:
Refer to postal address Nikbakht School of Engineering, University of Sistan and Baluchistan, University Boulevard- Zahedan- Sistan and Baluchestan for correspondence, Or email address sajad.kerimi1819@gmail.com, Or call
With mobile number 09150369859, in the name of Sajjad Karimi pour to answer and receive the documents or data you want

How to obtain:
After verifying the identity of the requesting person and the agreement of the professor's Help and Advisor also the relevant university, the main findings will be sent to the person.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sajjad karimi pour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nikbakht School of Engineering, University of Sistan and Baluchestan, University Boulevard</address>
        <city>Zahdan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>98798155</zip>
        <telephone>+98 54 3113 6456</telephone>
        <email>info@usb.ac.ir</email>
        <affiliation>The University of Sistan and Baluchestan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sajjad karimi pour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nikbakht School of Engineering, University of Sistan and Baluchestan, University Boulevard</address>
        <city>Zahdan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>98798155</zip>
        <telephone>+98 54 3113 6456</telephone>
        <email>sajad.karimi1819@gmail.com</email>
        <affiliation>The University of Sistan and Baluchestan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Completion of consent form for cooperation in research work.
Non-public physical education physical education male students that have 1 to select units.
Subjects do not have regular physical activity during the last 6 months.
At least 6 months before the start of the study, they did not use omega-3 supplements, antioxidants or certain medications.
Lack of specific disease and having physical health of subjects.
Non-use of cigarettes and tobacco.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Physical Education Students or Students who Have Elected Physical Education 2.
Failure to complete the consent form for cooperation in the research project.
Subjects with respiratory, cardiac or other diseases.
Subjects use a specific drug or supplement 6 months before or at the present time.
Subjects have regular activities such as walking, bodybuilding, soccer and ... in the last 6 months or now.
Smoking or tobacco use.</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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: During this 6-week period, no activity will be involved, nor will any use be made.</i_keyword>
      <i_keyword>First Intervention group: High-Intensity interval training (40 m round trip speed for 6 weeks,  4 repetitions in the first week and 8 repetitions in the sixth week). Along with taking 2 grams of omega-3 jelly capsules made by Zahravi Iran Co. at breakfast and dinner1 gram plus one glass of water for 6 weeks.</i_keyword>
      <i_keyword>Second Intervention group: High-Intensity interval training (40 m round trip speed for 6 weeks,  4 repetitions in the first week and 8 repetitions in the sixth week).</i_keyword>
      <i_keyword>Third Intervention group: with taking 2 grams of omega-3 jelly capsules made by Zahravi Iran Co. at breakfast and dinner1 gram plus one glass of water for 6 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum levels of Brain-derived neurotrophic factor (BDNF). Timepoint: Measuring serum BDNF levels at the beginning of the study 24 hours before the start of the The first session of the training and at the end (6 weeks) 48 hours after the last training session. Method of measurement: Blood serum sampling-Laboratory kit for serum human BDNF.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hematology Indicators. Timepoint: At the beginning of the study, 24 hours before the start of the protocol and at the end of the protocol (6 weeks), 48 hours after the last session of the protocol. Method of measurement: American Sysemox Electron Microscope.</sec_outcome>
      <sec_outcome>Weight. Timepoint: At the beginning of the study, 24 hours before the start of the protocol and at the end of the protocol (6 weeks), 48 hours after the last session of the protocol. Method of measurement: German Seca Digital Scale.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: At the beginning of the study, 24 hours before the start of the protocol and at the end of the protocol (6 weeks), 48 hours after the last session of the protocol. Method of measurement: Pressure gauge Japanese ALPK2.</sec_outcome>
      <sec_outcome>Body fat percentage. Timepoint: At the beginning of the study, 24 hours before the start of the protocol and at the end of the protocol (6 weeks), 48 hours after the last session of the protocol. Method of measurement: Japan's Caliph Yagamy.</sec_outcome>
      <sec_outcome>Maximum Oxygen Consumption. Timepoint: At the beginning of the study, 24 hours before the start of the protocol and at the end of the protocol (6 weeks), 48 hours after the last session of the protocol. Method of measurement: Test a mile running in the field.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: Measuring serum BDNF levels at the beginning of the study, 24 hours before the start of the protocol and at the end of the protocol (6 weeks), 48 hours after the last session of the protocol. Method of measurement: Digital scales and gauges  German Seca Model.</sec_outcome>
      <sec_outcome>Waist to hip. Timepoint: َََAt the beginning of the study, 24 hours before the start of the protocol and at the end of the protocol (6 weeks), 48 hours after the last session of the protocol. Method of measurement: Strip meter.</sec_outcome>
      <sec_outcome>Lipid Profiles. Timepoint: َََAt the beginning of the study, 24 hours before the start of the protocol and at the end of the protocol (6 weeks), 48 hours after the last session of the protocol. Method of measurement: Blood serum sampling, Special kits.</sec_outcome>
      <sec_outcome>Dietary control of subjects. Timepoint: Once at the beginning of the research protocol (first week), again at the end of the week (Sixth week), three consecutive days(Includes two non-holiday days and one day end weekend). Method of measurement: Using a 24-hour questionnaire, the dietary reminder was completed by the subjects, Calculated by the researcher by referring to the guidebook on nutritional value of Iranian diets.</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>The University of Sistan and Baluchestan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-25</approval_date>
        <contact_name>Ethics committee of Sport Sciences Research Institute of Iran</contact_name>
        <contact_address>No. 3, - Alley 5., - Miremad Street., Professor Motahhari Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
