<?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>IRCT20180912041018N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-20</date_registration>
      <primary_sponsor>Semnan University</primary_sponsor>
      <public_title>Investigation of the effect of selenium and exercise on the elderly</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks of selenium supplementation and Concurrent training on SOD, CAT, CRP, GPX, GR and lipid profile in elderly men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73645</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: After finalizing the 48 subjects and assigning codes 1 to 48 to each subject individually and using the PASS 2023 software (NCSS, LLC, Kaysville, Utah, USA, ncss.com/software/pass), the subjects were will be randomly divided into 6 groups of 8 people, Blinding description: This research will be done in a double blind way. After explaining the conditions and how to conduct the research to the subjects, they will be divided into six groups. Supplemental group, placebo group, control group, concurrent training group, concurrent training+supplement group, concurrent training+placebo group. None of the participants, the executive staff of nurses, physiotherapists, etc., practitioners and students (researcher) will know about the contents of the capsules. Which group will use the supplement and which group will use the placebo, the subjects and the researcher will not know. And this work will be determined by a third party as a reference person. In this way, the capsules containing placebo and supplement will be coded and provided by the researcher to the specified groups. At the end of the research and after collecting the blood sample and measuring the dependent variables, the data will be collected and provided to the supervisor, and after the data analysis and the results are determined, the codes will be opened and the supplement and placebo groups will be determined.</study_design>
      <phase>4</phase>
      <hc_freetext>Aging.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Concurrent training, 3 sessions per week, 60 minutes in the morning, strength and endurance training protocol will be performed on every other day and on even days. Intervention 2: Intervention group 2: Supplement who will consume 200 micrograms of Selenium supplement with Nature med brand made in the USA. Intervention 3: Intervention group 3: Concurrent training and supplementation, in addition to implementing the weekly Concurrent training protocol, three sessions of 60 minutes per session will consume 200 micrograms of selenium supplement daily. Intervention 4: Intervention group 4: Placebo, who will consume a capsule containing roasted wheat flour and similar to the capsule containing selenium. Intervention 5: Intervention group 5: Exercise and placebo, in addition to implementing the Concurrent training protocol three sessions a week, each session will take 60 minutes a day, a capsule containing a placebo (roasted wheat flour) and completely similar to the selenium capsule. Intervention 6: Control group: The control will have the same conditions as the other groups and will not receive any of the interventions.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rouhollah Haghshenas</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5 km of Damghan road</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>35131-19111</zip>
        <telephone>0098 23 3342194</telephone>
        <email>rhm@semnan.ac.ir</email>
        <affiliation>Semnan University</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>35131-19111</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>The age range of the subjects should be between 65 and 75.
Subjects must be able to perform daily activities and physical activity.</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>75 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Use of antioxidant supplements up to 6 months before conducting the research
Having chronic diseases, such as cardiovascular diseases, diabetes, acute joint disease, osteoporosis, bone fractures</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Factors influencing health status and contact with health services, Routine general health check-up of defined subpopulation,</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Concurrent training, 3 sessions per week, 60 minutes in the morning, strength and endurance training protocol will be performed on every other day and on even days.</i_keyword>
      <i_keyword>Intervention group 2: Supplement who will consume 200 micrograms of Selenium supplement with Nature med brand made in the USA.</i_keyword>
      <i_keyword>Intervention group 3: Concurrent training and supplementation, in addition to implementing the weekly Concurrent training protocol, three sessions of 60 minutes per session will consume 200 micrograms of selenium supplement daily.</i_keyword>
      <i_keyword>Intervention group 4: Placebo, who will consume a capsule containing roasted wheat flour and similar to the capsule containing selenium.</i_keyword>
      <i_keyword>Intervention group 5: Exercise and placebo, in addition to implementing the Concurrent training protocol three sessions a week, each session will take 60 minutes a day, a capsule containing a placebo (roasted wheat flour) and completely similar to the selenium capsule.</i_keyword>
      <i_keyword>Control group: The control will have the same conditions as the other groups and will not receive any of the interventions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Glutathione peroxidase. Timepoint: Measurement of glutathione peroxidase at the beginning of the study (before the start of the intervention) and 48 hours after the last training session. Method of measurement: By ELISA method and using ELISA kit.</prim_outcome>
      <prim_outcome>Glutathione reductase. Timepoint: Measurement of Glutathione reductase at the beginning of the study (before the start of the intervention) and 48 hours after the last training session. Method of measurement: by ELISA method and using ELISA kit.</prim_outcome>
      <prim_outcome>C Reactive Protein. Timepoint: Measurement of C-reactive protein at the beginning of the study (before the start of the intervention) and 48 hours after the last training session and in the fasting state. Method of measurement: By ELISA method and using ELISA kit.</prim_outcome>
      <prim_outcome>Superoxide Dismutase. Timepoint: At the beginning of the study (before the start of the intervention) and 48 hours after the last training session and in the fasting state. Method of measurement: By ELISA method and using ELISA kit.</prim_outcome>
      <prim_outcome>Catalase. Timepoint: At the beginning of the study (before the start of the intervention) and 48 hours after the last training session and in the fasting state. Method of measurement: By ELISA method and using ELISA kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Low-density lipoproteins. Timepoint: At the beginning of the study (before the start of the intervention) and 48 hours after the last training session and fasting state. Method of measurement: ELISA method and use of ELISA kit.</sec_outcome>
      <sec_outcome>Very low density lipoprotein. Timepoint: At the beginning of the study (before the start of the intervention) and 48 hours after the last training session and fasting state. Method of measurement: ELISA method and use of ELISA kit.</sec_outcome>
      <sec_outcome>Cholesterol. Timepoint: At the beginning of the study (before the start of the intervention) and 48 hours after the last training session and fasting state. Method of measurement: ELISA method and use of ELISA kit.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: At the beginning of the study (before the start of the intervention) and 48 hours after the last training session and fasting state. Method of measurement: ELISA method and use of ELISA kit.</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>Semnan University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-31</approval_date>
        <contact_name>Semnan University of Medical Sciences and Health Services</contact_name>
        <contact_address>Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran. Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
