<?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>IRCT20170326033146N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-26</date_registration>
      <primary_sponsor>Razi University</primary_sponsor>
      <public_title>The effect of Taurine on cognitive and physical function</public_title>
      <acronym></acronym>
      <scientific_title>Acute effects of low and high doses of Taurine on physical and cognitive functions in 60-69 years old men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61222</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Prevention, Randomization description: Someone other than the researchers will use the random allocation software for the allocation of the subjects by a randomized blocking method. During the process of allocation, each subject will be given a unique identification code that will be given to the main researchers together with the necessary treatment (Different doses of taurine or placebo).
The identification code will be used as a label to identify the group of each subject for data analysis after completion of the study. The random allocation software program can generate block randomization. The sample size and the name of the three groups (Different doses of taurine and placebo) will be defined in the randomization main menu of the software. Then, the block design will be entered as equal size. Also, the format of the unique identification code will be defined as alphanumeric with a fixed length. The last step is to generate the random list in which each entry in the list consists of a unique identification code and a group name, Blinding description: Because this study is double-blind, the subjects and researchers will not know who takes taurine or placebo, and someone else will assess the results. Also, in order not to detect different doses of taurine and placebo, they will be prepared in the same capsules and the placebo group will use maltodextrin powder.</study_design>
      <phase>3</phase>
      <hc_freetext>.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: First, the desired tests will be performed. Subjects will be supplemented one hour before the tests. One gram of taurine supplement will be dissolved in powder in 150 ml of water. Then the desired tests are repeated. In the first week, participants will be divided into three groups of five: one gram of taurine, six grams of taurine, and a placebo. A one-week removal period will be considered. Then in the second and third weeks, the groups will move. Intervention 2: Intervention group 2: First, the desired tests will be performed. Subjects will be supplemented one hour before the tests. Six grams of the taurine supplement will be dissolved in powder in 150 ml of water. Then the desired tests are repeated. In the first week, participants will be divided into three groups of five: one gram of taurine, six grams of taurine, and a placebo. A one-week removal period will be considered. Then in the second and third weeks, the groups will move. Intervention 3: Control group: First, the desired tests will be performed. Subjects will be supplemented one hour before the tests.1 g of maltodextrin will be dissolved in powder in 150 ml of water. Then the desired tests are repeated. In the first week, participants will be divided into three groups of five: one gram of taurine, six grams of taurine, and a placebo. A one-week removal period will be considered. Then in the second and third weeks, the groups will move.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vahid Tadibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Sports Sciences, Razi University, University Blvd., Taghe Bostan</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3427 9265</telephone>
        <email>vtadibi@yahoo.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vahid Tadibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Sports Sciences, Razi University, University Blvd., Taghe Bostan</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3427 9265</telephone>
        <email>vtadibi@yahoo.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gender
Living in SanandajAge
range 60 to 69 years
BMI 18 to 24 (kg / m2)
Provide valid evidence of complete vaccination of COVID19 and at least three weeks after the second dose
Having the desired level of physical fitness to perform tests based on the Physical Activity Readiness Questionnaire (Q-PAR) and physician approval</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>69 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having any chronic disease
Take any supplement in the two months before the start of the study
Smoking</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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: First, the desired tests will be performed. Subjects will be supplemented one hour before the tests. One gram of taurine supplement will be dissolved in powder in 150 ml of water. Then the desired tests are repeated. In the first week, participants will be divided into three groups of five: one gram of taurine, six grams of taurine, and a placebo. A one-week removal period will be considered. Then in the second and third weeks, the groups will move.</i_keyword>
      <i_keyword>Intervention group 2: First, the desired tests will be performed. Subjects will be supplemented one hour before the tests. Six grams of the taurine supplement will be dissolved in powder in 150 ml of water. Then the desired tests are repeated. In the first week, participants will be divided into three groups of five: one gram of taurine, six grams of taurine, and a placebo. A one-week removal period will be considered. Then in the second and third weeks, the groups will move.</i_keyword>
      <i_keyword>Control group: First, the desired tests will be performed. Subjects will be supplemented one hour before the tests.1 g of maltodextrin will be dissolved in powder in 150 ml of water. Then the desired tests are repeated. In the first week, participants will be divided into three groups of five: one gram of taurine, six grams of taurine, and a placebo. A one-week removal period will be considered. Then in the second and third weeks, the groups will move.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: At the beginning of the study and after consuming one and six grams of taurine and a placebo. Method of measurement: Balance is measured using Timed up and go test - TUG.</prim_outcome>
      <prim_outcome>Muscular endurance. Timepoint: At the beginning of the study and after consuming one and six grams of taurine and a placebo. Method of measurement: Muscular endurance is measured using the 30s chair stand test.</prim_outcome>
      <prim_outcome>Cardiorespiratory endurance. Timepoint: At the beginning of the study and after consuming one and six grams of taurine and a placebo. Method of measurement: Cardiorespiratory endurance is measured using a 6-min walk test.</prim_outcome>
      <prim_outcome>Cognitive function. Timepoint: At the beginning of the study and after consuming one and six grams of taurine and a placebo. Method of measurement: Cognitive function is measured using the MMSE test.</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>Razi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-12</approval_date>
        <contact_name>Ethics committee of Kermanshah Razi University</contact_name>
        <contact_address>Tagh-e-Bostan, University St.Razi University, Central Laboratory،Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
