<?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>IRCT20180912041018N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-10</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Study the Effect of Exercise Training and  Supplementation of L-Arginine in elderly men</public_title>
      <acronym></acronym>
      <scientific_title>Study the Effect of Concurrent Training and Supplementation of L-Arginine on SIRT6, FBS and  Body Composition in Elderly men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35844</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using NCSS PASS11 software, Procedure menu, DOE submenu, subjects were randomly will be divided into four equal-sized groups, Blinding description: Since Exercise training cannot be masked in a way as, for instance, pharmacological substances, so an important level of blinding in exercise science research remains with the data collectors. In this single-blind study, due to the nature of the method, blinding will be done in the information gathering stage by a person who is completely unaware of the presence of individuals in the groups.</study_design>
      <phase>3</phase>
      <hc_freetext>aging.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First group of concurrent training+ supplement of l-arginine that in addition to the concurrent training, performed three sessions per week (coupled days), daily each subject received 1,000 mg of L-Arg capsule contain of L-arginine Hydrochloride, Microcrystalline Cellulose, P.V.P, Magnesium, Stearate after breakfast with full stomach. Intervention 2: Intervention group: secound, group of concurrent training+placebo, which in addition to implementing the exercise protocol three sessions per week for eight weeks, will also use placebo capsules similar to capsules of supplementary groups filled with maltodextrin. It should be noted that the investigator and subjects will not be informed of the contents of the capsule until the end of the protocol. Intervention 3: Intervention group: Third, group of supplement that for eight weeks, daily received 1,000 mg of placebo capsules .The capsules will have identical shape and appearance and contained L-Arg Hydrochloride, Microcrystalline Cellulose, P.V.P, Magnesium, Stearate (Karen Pharma &amp; Food Supplement Co) Prepared from Karen Pharmaceutical Company PNC, code 6261405113328 approved by the Ministry of Health of Iran. Intervention 4: Control group: There was no intervention on them, only they were asked to continue their normal life.</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:
The SPSS data used to support the findings of this study are available from the corresponding author upon request.

When:
The SPSS data used to support the findings of this study are available from the corresponding author upon request.

To whom:
The SPSS data used to support the findings of this study are available from the corresponding author upon request.

Conditions:
By authorizing the corresponding author and maintaining all the material and spiritual rights

Where to obtain:
The SPSS data used to support the findings of this study are available from the corresponding author upon request.

How to obtain:
The SPSS data used to support the findings of this study are available from the corresponding author upon request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Neda Gilani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Niayesh, Tabriz University of Medical Sciences</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3334 0308</telephone>
        <email>neda.gilani@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rouhollah Haghshenas</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>standard square</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513119111</zip>
        <telephone>+98 23 3336 3494</telephone>
        <email>rhm@semnan.ac.ir</email>
        <affiliation>Semnan University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>males in range of 60≤age≤75 years
Being able to do exercise movements</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having systematic strength training last 6 months (At least more than one session per week)
having to cardiovascular disease and joint and bone problems
Bone fractures
Use of any kind of antioxidant supplements</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>
      <i_code>Placebo</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First group of concurrent training+ supplement of l-arginine that in addition to the concurrent training, performed three sessions per week (coupled days), daily each subject received 1,000 mg of L-Arg capsule contain of L-arginine Hydrochloride, Microcrystalline Cellulose, P.V.P, Magnesium, Stearate after breakfast with full stomach.</i_keyword>
      <i_keyword>Intervention group: secound, group of concurrent training+placebo, which in addition to implementing the exercise protocol three sessions per week for eight weeks, will also use placebo capsules similar to capsules of supplementary groups filled with maltodextrin. It should be noted that the investigator and subjects will not be informed of the contents of the capsule until the end of the protocol.</i_keyword>
      <i_keyword>Intervention group: Third, group of supplement that for eight weeks, daily received 1,000 mg of placebo capsules .The capsules will have identical shape and appearance and contained L-Arg Hydrochloride, Microcrystalline Cellulose, P.V.P, Magnesium, Stearate (Karen Pharma &amp; Food Supplement Co) Prepared from Karen Pharmaceutical Company PNC, code 6261405113328 approved by the Ministry of Health of Iran.</i_keyword>
      <i_keyword>Control group: There was no intervention on them, only they were asked to continue their normal life</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sirtuin-6. Timepoint: Measuring Sirtuin-6 in the start of the study and 48 hours after the last training session. Method of measurement: Sirtuin6 concentrations assaye in plasma according to the manufacturers’ instructions using ELISA kits speciﬁc for human.</prim_outcome>
      <prim_outcome>Glucose. Timepoint: Measuring Glucose in the start of the study and 48 hours after the last training session. Method of measurement: برای اندازه گیری گلوکز خون ازروش آنزیماتیک کالری متری و کیت شرکت پارس آزمون ایران  و به ترتیب با دقت و حساسیت 1.3 %  و 1 mg/dl استفاده خواهد شد.</prim_outcome>
      <prim_outcome>Body Composition. Timepoint: Measuring Body Composition in the start of the study and 48 hours after the last training session. Method of measurement: Body Composition will be calculated as weight (kg) divided by the square of the height (m2).</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>2018-03-05</approval_date>
        <contact_name>ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Niayesh tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
