<?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>IRCT20141228020465N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-06-17</date_registration>
      <primary_sponsor>Ayatollah Boroujerdi University</primary_sponsor>
      <public_title>The effect of aerobic exercise and superfood supplementation on cell death</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks of aerobic training and NBS superfood supplement consumption on factors involved in cell death in men undergoing methadone treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-05-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83267</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Basic scienece, Blinding description: This study is designed as a double-blind study, so that both participants and researchers will be unaware of the group assignment (supplement/placebo). The supplement and placebo will be provided in identical packaging (in terms of appearance, labeling, and method of administration) and distributed by independent staff of the addiction treatment center who are not involved in other parts of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Addiction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Aerobic exercise with supplement intake for 8 weeks. Exercise protocol: First, the subjects will warm up for 10 minutes at an intensity of 50% of maximum heart rate. Aerobic exercise will be performed at an intensity of 75% to 85% of maximum heart rate for 40 minutes, three times a week. Finally, the subjects will cool down for 10 minutes at an intensity of 50% of maximum heart rate. The subjects will receive the NBS Superfood supplement at a rate of 4.5 grams per day orally, dissolved in water, and daily in three equal doses: 1.5 grams in the morning, 1.5 grams in the afternoon, and 1.5 grams in the evening. The supplements will be provided by NBS Superfood (NBS Organic Company, Turkey). Intervention 2: Intervention group 2: Aerobic exercise with placebo for 8 weeks. Subjects will first warm up for 10 minutes at an intensity of 50% HRmax. The aerobic exercise groups will perform high-intensity aerobic exercise (75% to 85% HRmax) for 40 minutes each time three times a week. Finally, subjects will cool down for 10 minutes at an intensity of 50% HRmax. The placebo will be 4.5 grams of potato starch orally per day, dissolved in water, in three equal doses: 1.5 grams in the morning, 1.5 grams in the afternoon, and 1.5 grams in the evening. Intervention 3: Subjects will receive 4.5 grams of NBS Superfood supplement orally, dissolved in water, daily in three equal doses for eight weeks: 1.5 grams in the morning (6 am to 12 pm), 1.5 grams in the afternoon (12 pm to 6 pm) and 1.5 grams in the evening. (from 6 pm to 12 am). The supplements will be provided by NBS Superfood (NBS Organic Company, Turkey). Intervention 4: Control group: The control group will receive only placebo for 8 weeks. They will receive 4.5 grams of potato starch orally, dissolved in water, in three equal doses: 1.5 grams in the morning, 1.5 grams in the afternoon, and 1.5 grams in the evening. They will not do any sports activities and will continue their lifestyle.</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 Its release schedule is not yet known.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Omidali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorramabad Road-3rd kilometer</address>
        <city>Bourojerd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>69199-69737</zip>
        <telephone>+98 66 4246 8320</telephone>
        <email>omidali.fatemeh@yahoo.com</email>
        <affiliation>Ayatollah Boroujerdi University (RA)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Negin Kordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorramabad Road-3rd kilometer</address>
        <city>Borujerd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>69199-69737</zip>
        <telephone>+98 66 4246 8320</telephone>
        <email>K_negin_69@yahoo.com</email>
        <affiliation>Ayatollah Boroujerdi University (RA)</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Negative urine test for morphine, cannabis, and methamphetamine.
The need to use methadone maintenance treatment for at least the past three months,
Absence of autoimmune diseases,
absence of cardiovascular and pulmonary diseases
absence of muscle and tendon injuries</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Unwillingness to participate in research
Being sick</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P04.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Newborn (suspected to be) affected by maternal use of drugs of addiction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Aerobic exercise with supplement intake for 8 weeks. Exercise protocol: First, the subjects will warm up for 10 minutes at an intensity of 50% of maximum heart rate. Aerobic exercise will be performed at an intensity of 75% to 85% of maximum heart rate for 40 minutes, three times a week. Finally, the subjects will cool down for 10 minutes at an intensity of 50% of maximum heart rate. The subjects will receive the NBS Superfood supplement at a rate of 4.5 grams per day orally, dissolved in water, and daily in three equal doses: 1.5 grams in the morning, 1.5 grams in the afternoon, and 1.5 grams in the evening. The supplements will be provided by NBS Superfood (NBS Organic Company, Turkey).</i_keyword>
      <i_keyword>Intervention group 2: Aerobic exercise with placebo for 8 weeks. Subjects will first warm up for 10 minutes at an intensity of 50% HRmax. The aerobic exercise groups will perform high-intensity aerobic exercise (75% to 85% HRmax) for 40 minutes each time three times a week. Finally, subjects will cool down for 10 minutes at an intensity of 50% HRmax. The placebo will be 4.5 grams of potato starch orally per day, dissolved in water, in three equal doses: 1.5 grams in the morning, 1.5 grams in the afternoon, and 1.5 grams in the evening.</i_keyword>
      <i_keyword>Subjects will receive 4.5 grams of NBS Superfood supplement orally, dissolved in water, daily in three equal doses for eight weeks: 1.5 grams in the morning (6 am to 12 pm), 1.5 grams in the afternoon (12 pm to 6 pm) and 1.5 grams in the evening. (from 6 pm to 12 am). The supplements will be provided by NBS Superfood (NBS Organic Company, Turkey).</i_keyword>
      <i_keyword>Control group: The control group will receive only placebo for 8 weeks. They will receive 4.5 grams of potato starch orally, dissolved in water, in three equal doses: 1.5 grams in the morning, 1.5 grams in the afternoon, and 1.5 grams in the evening. They will not do any sports activities and will continue their lifestyle.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ferroptosis. Timepoint: Before the intervention and 8 weeks after the end of the intervention. Method of measurement: Blood sample, serum separation, ELISA kit, use of ELISA reader.</prim_outcome>
      <prim_outcome>Oxidative stress. Timepoint: Before the intervention and 8 weeks after the end of the intervention. Method of measurement: Blood sample, serum separation, ELISA kit, use of ELISA reader.</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>Ayatollah Boroujerdi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-04-20</approval_date>
        <contact_name>Research Ethics Committee of the Sports Sciences Research Institute</contact_name>
        <contact_address>Number 3,Fifth Alley -Mir Emad St.-Ostad Motahari St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
