<?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>IRCT20211023052854N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-27</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of continuous training and rice bran on oxidative stress and hemodynamic indices of overweight men</public_title>
      <acronym></acronym>
      <scientific_title>The effect of continuous training with rice bran supplementation on selected physical fitness factors, some oxidative stress and hemodynamic indicators of overweight policemen</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59598</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 80 policemen with overweight will be selected by available sampling method. Through a lottery (participants' names were written on paper and will be divided into 4 groups (3 intervention and 1 control groups) through random lottery), Blinding description: In this research, responsible for collecting and processing the data, the type of intervention, and the participants in the research groups are unaware.</study_design>
      <phase>N/A</phase>
      <hc_freetext>fat.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Medium intensity continuous exercises for 12 weeks, 3 sessions per week will be used. Each session of continuous training for 60 minutes of walking or running on a treadmill includes 10 minutes of warm-up with an intensity of 50 to 60% of maximum heart rate, 45 minutes with 60 to 70% of maximum heart rate and 5 minutes of cooling. Participants will be trained to maintain the intensity of the workout by adjusting the speed or incline of the treadmill. For each session, heart rate, speed and incline will be recorded. Intervention 2: Intervention group 2: Rice bran group will receive 10 gram packages of rice bran supplement of Bijar Quatterm Company 80% extraction for 6 weeks consumption (twice daily). They are asked to consume one packet before breakfast and one packet before dinner, and if desired, pour 10 grams of each packet into their usual yogurt and consume it. Intervention 3: Intervention group 3: Combining continuous exercise with rice bran supplementation. Intervention 4: Control group: placebo They will receive a placebo for 12 weeks.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mojtaba Moazami Goodarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lakan Blv</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41476-54919</zip>
        <telephone>+98 13 3342 4086</telephone>
        <email>moazami1400@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojtaba Moazami Goodarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lakan Blv</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41476-54919</zip>
        <telephone>+98 13 3342 4086</telephone>
        <email>moazami1400@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>having a body mass index between 25 and 29.9
Not participating in regular sports activities for 2 years
Not having Chronic diseases
No respiratory, metabolic, cardiovascular, renal and hepatic diseases</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 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>Rehabilitation</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: Medium intensity continuous exercises for 12 weeks, 3 sessions per week will be used. Each session of continuous training for 60 minutes of walking or running on a treadmill includes 10 minutes of warm-up with an intensity of 50 to 60% of maximum heart rate, 45 minutes with 60 to 70% of maximum heart rate and 5 minutes of cooling. Participants will be trained to maintain the intensity of the workout by adjusting the speed or incline of the treadmill. For each session, heart rate, speed and incline will be recorded</i_keyword>
      <i_keyword>Intervention group 2: Rice bran group will receive 10 gram packages of rice bran supplement of Bijar Quatterm Company 80% extraction for 6 weeks consumption (twice daily). They are asked to consume one packet before breakfast and one packet before dinner, and if desired, pour 10 grams of each packet into their usual yogurt and consume it.</i_keyword>
      <i_keyword>Intervention group 3: Combining continuous exercise with rice bran supplementation</i_keyword>
      <i_keyword>Control group: placebo They will receive a placebo for 12 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Aerobic power. Timepoint: 48 hours before intervention and 48 hours after 12 weeks of intervention. Method of measurement: Aerobic power in this study will be measured by a shuttle run test.</prim_outcome>
      <prim_outcome>Anaerobic power. Timepoint: 48 hours before intervention and 48 hours after 12 weeks of intervention. Method of measurement: Anaerobic power in this study will be measured by Rast test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Oxidative stress indices. Timepoint: 48 hours before intervention and 48 hours after 12 weeks of intervention. Method of measurement: Measurements will be taken between 7 and 8 in the morning as a 12-hour fast and in the form of a venous blood sample with the help of a syringe while sitting on a chair.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: 48 hours before intervention and 48 hours after 12 weeks of intervention. Method of measurement: Subjects' systolic and diastolic blood pressure will be measured using a Beaur digital sphygmomanometer.</sec_outcome>
      <sec_outcome>Lipid profile. Timepoint: 48 hours before intervention and 48 hours after 12 weeks of intervention. Method of measurement: Lipid profiles including LDL, HDL, TG, VLDL and cholesterol are measured enzymatically with the kit of Pars-Azmon Company (made in Iran-Karaj).</sec_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: 48 hours before intervention and 48 hours after 12 weeks of intervention. Method of measurement: It will be tested by laboratory measurements in the blood serum.</sec_outcome>
      <sec_outcome>Inflammatory cytokines. Timepoint: 48 hours before intervention and 48 hours after 12 weeks of intervention. Method of measurement: Measurement of cytokines using special IL-6 and IL-1β Diaclone kits made in France will be used according to the manufacturer's instructions and ELISA method.</sec_outcome>
      <sec_outcome>Hs-CRP. Timepoint: 48 hours before intervention and 48 hours after 12 weeks of intervention. Method of measurement: It is measured with the kit of Pars-Azmon Company (made in Iran-Karaj) and by enzymatic method.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-19</approval_date>
        <contact_name>Research Ethics Committees of Islamic Azad University -Rasht Branch</contact_name>
        <contact_address>Lakan Blv Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
