<?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>IRCT20121110011421N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-12</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Spirulina supplementation on plasma markers of exercise-induced muscle damage</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Spirulina supplementation on plasma markers of exercise-induced muscle damage, IL-6 and antioxidant capacity in Tekwando athletes: a cross-over trail.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>18</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11692</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Other design features: The study is designed as a crossover. The study has two periods with a duration of 21 days. In the first period, group 1 receives spirulina and in the second period receives a placebo. Group 2 receives placebo in the first period and spirulina in the second period. The two study periods are separated by a 14-day washout period, Randomization description: To create random sequences in this study which has two groups, the coin toss method was used. The first group includes people who first receive spirulina and then placebo, and the second group receives first placebo and then spirulina. Coin toss was performed according to the sample size and individuals were randomly assigned to one of the two groups, Blinding description: Supplement and placebo delivered to the two groups are completely similar in appearance and the researcher will be aware of its coding at the end of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Exercise-induced muscle damage.</hc_freetext>
      <i_freetext>This study has two groups. Group 1 receives spirulina in the first period of study and placebo in the second period of study. Group 2 receive placebo in the first period and spirulina in the second period. The two study periods are separated by a 14-day washout period. The duration of receiving spirulina or placebo in the first and second period is 21 days.The spirulina sachet contained 8 g of Spirulina flavored with lemon and mint (Qeshm Island Science and Technology Park by  Drotat Setareh Qeshm). The placebo sachet was 8 g starch flour with the same flavor and green food coloring..</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:
According to the field of study and information received from people, all parts of it have the ability to share data

When:
Access from the second half of 1400

To whom:
All researchers in the field of sport nutrition

Conditions:
All data obtained can be used for various analyzes

Where to obtain:
The request should be sent to the e-mail of Dr. Kurosh Djafarian or Arvin Kashani.
kdjafarian@tums.ac.ir
kashani.arvin@gmail.com

How to obtain:
After receiving the application and reviewing it by email, it will be sent to the people within 2 working weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arvin kashani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vesk Ave., 14 street number 31</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4545656456</zip>
        <telephone>+98 21 4436 6496</telephone>
        <email>kashani.arvin@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kurosh djafarian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vesal shirazi Ave., SNSD</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 8898 4837</telephone>
        <email>kdjafarian@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male Taekwondo Athletes
Taekwondo athletes with experience of at least 3 years
Age from 18 to 35 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Tobacco and drug use in the last year
Use of anti-inflammatory drugs in the last three months
Follow special and unusual diets in the last three months
Consumers of sports supplements in the last three months
Having chronic diseases that require a person to take medicine
People weighing less than 40 kg
Blood donors during the month before the test
People with illness or surgery in the last 3 months</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>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This study has two groups. Group 1 receives spirulina in the first period of study and placebo in the second period of study. Group 2 receive placebo in the first period and spirulina in the second period. The two study periods are separated by a 14-day washout period. The duration of receiving spirulina or placebo in the first and second period is 21 days.The spirulina sachet contained 8 g of Spirulina flavored with lemon and mint (Qeshm Island Science and Technology Park by  Drotat Setareh Qeshm). The placebo sachet was 8 g starch flour with the same flavor and green food coloring.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Plasma levels of the  lactate dehydrogenase enzyme (muscle damage Index). Timepoint: Day 1 after exercise and day 22 after exercise, after a 14-day washout period, again day 1 after exercise and day 22 after exercise (4 time in total). Method of measurement: Elaisa test.</prim_outcome>
      <prim_outcome>Plasma levels of the creatine kinase enzyme (muscle damage Index). Timepoint: Day 1 after exercise and day 22 after exercise, after a 14-day washout period, again day 1 after exercise and day 22 after exercise (4 time in total). Method of measurement: Elaisa test.</prim_outcome>
      <prim_outcome>Plasma levels of Interleukin 6. Timepoint: Day 1 after exercise and day 22 after exercise, after a 14-day washout period, again day 1 after exercise and day 22 after exercise (4 time in total). Method of measurement: IL 6 kit.</prim_outcome>
      <prim_outcome>Total antioxidant capacity (TAC). Timepoint: Day 1 after exercise and day 22 after exercise, after a 14-day washout period, again day 1 after exercise and day 22 after exercise (4 time in total). Method of measurement: Total antioxidant assay kit.</prim_outcome>
      <prim_outcome>Activity of Super oxide dismutase enzyme (SOD). Timepoint: Day 1 after exercise and day 22 after exercise, after a 14-day washout period, again day 1 after exercise and day 22 after exercise (4 time in total). Method of measurement: Super oxide dismutase assay kit.</prim_outcome>
      <prim_outcome>Glutathione peroxidase enzyme activity. Timepoint: Day 1 after exercise and day 22 after exercise, after a 14-day washout period, again day 1 after exercise and day 22 after exercise (4 time in total). Method of measurement: Glutathione peroxidase assay kit.</prim_outcome>
      <prim_outcome>Plasma level of malondialdehyde. Timepoint: Day 1 after exercise and day 22 after exercise, after a 14-day washout period, again day 1 after exercise and day 22 after exercise (4 time in total). Method of measurement: Malondialdeyde assay kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: Day 1 after exercise and day 22 after exercise, after a 14-day washout period, again day 1 after exercise and day 22 after exercise (4 time in total). Method of measurement: Seca Scale.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-13</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Ghods street., Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
