<?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>IRCT2014081618814N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-12-26</date_registration>
      <primary_sponsor>Vice chancellor for research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Omega-3 supplementation on immune responses in elite paddlers</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Omega-3 supplementation on immune responses in elite paddlers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16946</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece.</study_design>
      <phase>2</phase>
      <hc_freetext>It has not ICD10 code..</hc_freetext>
      <i_freetext>Intervention 1: Test group: subjects in test group will recievel 6.0 g/day fish-oil supplementation in capsules (American,Vita Cost) containing 3.6 g of n-3 polyunsaturate fatty acids containing 2400 mg of EPA and 1200 mg DHA for 4 weeks. Moreover, They will experience the increasing intensive exercise during the same time.Blood samples will be collected 48hr before and after study period. Intervention 2: Placebo group: Subjects in placebo group will receive 6gr/day placebo capsules containing mineral oil purchased from Zahravi Pharmaceutical Inc. (Iran) for 4 weeks. Moreover, all subjects will experience the increasing intensive exercise. Blood samples will be collected 48hr before and after study period.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>http://www.sciencedirect.com/science/article/pii/S0952327815001052</results_url_link>
      <results_summary>           Background&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Physical exercise can induce imbalance of different cytokines by leading them towards an inflammatory and immunosuppressive milieu. Fish-oil (FO) supplementation may modulate the mentioned skewed balance following intense exercise. Therefore, we decided to investigate the effect of intense physical exercise and FO supplementation on cytokine production and helper T (Th) cell phenotype in male elite paddlers.&lt;br /&gt;&#13;
Subjects and methods&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Male elite paddlers consumed 6 g/day of either FO capsules (n=11) containing 3.6 g long chain n-3 polyunsaturated fatty acids (1.2 g docosahexaenoic acid and 2.4 g eicosapentaenoic acid) or placebo capsules (n=11) for 4 weeks. The paddlers simultaneously undertook a program of increasing exercise. Blood samples were taken from all the subjects 48 h before and after the 4 weeks of supplementation.&lt;br /&gt;&#13;
Results&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Our results show that while FO supplementation decreases the production of tumor necrosis factor (TNF)-α and interleukin (IL)-1β in the elite paddlers, it increases the production of IL-6. On the other hand, while there was no change in IL-4 secretion, the production of interferon (IFN)-γ was significantly decreased after 4 weeks FO consumption. We also showed that the production of IL-10 was significantly higher in the FO group compared to the placebo. Finally, we found that fish-oil consumption shifts the balance between Th cells towards Th2 phenotype during intensive exercise.&lt;br /&gt;&#13;
Conclusion&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Our results suggest that the consumption of n-3 polyunsaturated fatty acids during intense exercise can induce the anti-inflammatory and immunosuppressive cytokine networks that are associated with a reduced Th1/Th2 ratio in elite paddlers.</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>Farhad Jadidi-Niaragh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Keshavarz boulevard, Tehran, PO Box 6446-14155, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8895 4913</telephone>
        <email>f-jadidin@razi.tums.ac.ir; farhad_jadidi1986@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farhad Jadidi-Niaragh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Keshavarz boulevard, Tehran, PO Box 6446-14155, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8895 4913</telephone>
        <email>f-jadidin@razi.tums.ac.ir; farhad_jadidi1986@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The main inclusion criteria: 18 to 30 years of age, non-smoking, agree to avoid sea foods throughout the study,sign informed consent.&#13;
The main exclusion criteria: History of cardiovascular disease or diabetes, allergy to fish oil,  appearance of intestinal side effects such as chronic and acute abdominal pains, diarrhea, and vomiting, acute fever and headache, consumption of anti-coagulation drugs such as aspirin or warfarin.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></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>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Test group: subjects in test group will recievel 6.0 g/day fish-oil supplementation in capsules (American,Vita Cost) containing 3.6 g of n-3 polyunsaturate fatty acids containing 2400 mg of EPA and 1200 mg DHA for 4 weeks. Moreover, They will experience the increasing intensive exercise during the same time.Blood samples will be collected 48hr before and after study period.</i_keyword>
      <i_keyword>Placebo group: Subjects in placebo group will receive 6gr/day placebo capsules containing mineral oil purchased from Zahravi Pharmaceutical Inc. (Iran) for 4 weeks. Moreover, all subjects will experience the increasing intensive exercise. Blood samples will be collected 48hr before and after study period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Age. Timepoint: prior to study. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Height. Timepoint: prior to study. Method of measurement: meter.</prim_outcome>
      <prim_outcome>Weight. Timepoint: prior to study. Method of measurement: balance.</prim_outcome>
      <prim_outcome>Lean body mass. Timepoint: prior to study. Method of measurement: InBody-520 instrument.</prim_outcome>
      <prim_outcome>Blood fat. Timepoint: prior to study. Method of measurement: laboratory.</prim_outcome>
      <prim_outcome>Maximal oxygen uptake. Timepoint: prior to study. Method of measurement: CASMED instrument.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>TNF-alpha level. Timepoint: 48 hr before and after study period. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>IL-1beta. Timepoint: 48 hr before and after study period. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>IL-6 level. Timepoint: 48 hr before and after study period. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>IFN-gamma level. Timepoint: 48 hr before and after study period. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>IL-4 level. Timepoint: 48 hr before and after study period. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>IL-10 level. Timepoint: 48 hr before and after study period. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Th1 frequency. Timepoint: 48 hr before and after study period. Method of measurement: Flow cytometry.</sec_outcome>
      <sec_outcome>Th2 frequency. Timepoint: 48 hr before and after study period. Method of measurement: Flow cytometry.</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>Vice chancellor for research, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-10-28</approval_date>
        <contact_name>Ethical Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Ethical Committee of Tehran University of Medical Sciences, Keshavarz boulevard, Tehran, PO Box 6446-14155, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
