<?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>IRCT20230228057569N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-24</date_registration>
      <primary_sponsor>Iranian academic center for education culture and research</primary_sponsor>
      <public_title>The effect of eight weeks intense interval training (HIIT) with white tea on inflammatory indices, oxidative stress and muscle damage in overweight and obesity men</public_title>
      <acronym>Tabriz HIIT &amp; White Tea Study</acronym>
      <scientific_title>The effect of eight weeks intense interval training (HIIT) with white tea on inflammatory indices, oxidative stress and muscle damage in overweight and obesity men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68913</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After being informed and invited to participate in the sports plan and among the covered volunteers, after matching in terms of anthropometric characteristics (including fat percentage, body mass index, height and weight), not having any chronic diseases such as metabolic syndrome, disease 36 healthy inactive men with confirmed heart disease and a history of hospitalization or congenital, no history of food allergy, use of drugs affecting inflammatory indicators, oxidative stress and muscle damage, according to the objectives and nature of the research and taking into account previous studies and existing conditions and non-athletes are voluntarily selected from among the men covered by the health center and with the mentioned BMI and randomly assigned to the groups.
For random allocation, between 00 and 36 will be our identification numbers. The first number in this domain is placed in group 1, the second number in group 2, the third number in group 3, and so on.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Changes in inflammatory indices, oxidative stress and muscle damage in overweight and obese men.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: intense interval training group, the whole protocol includes 10 weeks of running training. The first 2 weeks are intended to prepare the participants and the other 8 weeks cover the main course of treatment. The first two weeks start for initial preparation, which is to prepare for heavy training, intense interval training, with an intensity of 50 to 80% of the reserve heart rate.An intense periodic exercise program in the form of running (work) and walking (rest) with 45-second bursts of activity with an intensity of 80 to 90% of the reserve heart rate in the third and fourth weeks and 30-second bursts with an intensity of 90 to 100 The reserve heart rate percentage in the fifth to tenth weeks is considered for three sessions per week. Intervention 2: The second intervention group: white tea group, the groups including white tea should consume bulk Chinese white tea for 10 weeks, three times a day (morning, noon and night) at the same time and one hour before meals.Each serving should include one cup (two grams) of dry white tea in 200 ml of 80 degree water. Intervention 3: The third intervention group: intense interval training group with white tea. the whole protocol includes 10 weeks of running training. The first 2 weeks are intended to prepare the participants and the other 8 weeks cover the main course of treatment. The first two weeks start for initial preparation, which is to prepare for heavy training, intense interval training, with an intensity of 50 to 80% of the reserve heart rate.An intense periodic exercise program in the form of running (work) and walking (rest) with 45-second bursts of activity with an intensity of 80 to 90% of the reserve heart rate in the third and fourth weeks and 30-second bursts with an intensity of 90 to 100 The reserve heart rate percentage in the fifth to tenth weeks is considered for three sessions per week. the groups including white tea should consume bulk Chinese white tea for 10 weeks, three times a day (morning, noon and night) at the same time and one hour before meals.Each serving should include one cup (two grams) of dry white tea in 200 ml of 80 degree water.</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>Morteza Bairami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 7, 4th floor, Omid Apartment 7, Jannet Alley 5, Jannet St., Metin St., end of Rodaki St.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715653578</zip>
        <telephone>+98 914 711 6938</telephone>
        <email>mortaza.beirami@gmail.com</email>
        <affiliation>Iranian academic center for education culture and research</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Morteza Bairami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 7, 4th floor, Omid Apartment 7, Jannet Alley 5, Jannet St., Metin St., end of Rodaki St.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715653578</zip>
        <telephone>+98 914 711 6938</telephone>
        <email>mortaza.beirami@gmail.com</email>
        <affiliation>Iranian academic center for education culture and research</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Subjects will be selected from people who plan to participate in a sports program for the first time, or those who have been inactive, inactive, or inactive for more than a year.
According to the questionnaire, they are medically healthy and do not have any metabolic or other diseases.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>55 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>They have not used cigarettes, food supplements and therapeutic drugs in the last 3 months.</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: intense interval training group, the whole protocol includes 10 weeks of running training. The first 2 weeks are intended to prepare the participants and the other 8 weeks cover the main course of treatment. The first two weeks start for initial preparation, which is to prepare for heavy training, intense interval training, with an intensity of 50 to 80% of the reserve heart rate.An intense periodic exercise program in the form of running (work) and walking (rest) with 45-second bursts of activity with an intensity of 80 to 90% of the reserve heart rate in the third and fourth weeks and 30-second bursts with an intensity of 90 to 100 The reserve heart rate percentage in the fifth to tenth weeks is considered for three sessions per week.</i_keyword>
      <i_keyword>The second intervention group: white tea group, the groups including white tea should consume bulk Chinese white tea for 10 weeks, three times a day (morning, noon and night) at the same time and one hour before meals.Each serving should include one cup (two grams) of dry white tea in 200 ml of 80 degree water.</i_keyword>
      <i_keyword>The third intervention group: intense interval training group with white tea. the whole protocol includes 10 weeks of running training. The first 2 weeks are intended to prepare the participants and the other 8 weeks cover the main course of treatment. The first two weeks start for initial preparation, which is to prepare for heavy training, intense interval training, with an intensity of 50 to 80% of the reserve heart rate.An intense periodic exercise program in the form of running (work) and walking (rest) with 45-second bursts of activity with an intensity of 80 to 90% of the reserve heart rate in the third and fourth weeks and 30-second bursts with an intensity of 90 to 100 The reserve heart rate percentage in the fifth to tenth weeks is considered for three sessions per week. the groups including white tea should consume bulk Chinese white tea for 10 weeks, three times a day (morning, noon and night) at the same time and one hour before meals.Each serving should include one cup (two grams) of dry white tea in 200 ml of 80 degree water.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes in inflammatory indices, oxidative stress and muscle damage. Timepoint: Measurement of inflammatory indices, oxidative stress and muscle damage before and after the intervention. Method of measurement: The activity of creatine kinase (CK) and lactate dehydrogenase (LDH) is estimated from the serum sample that was analyzed by ELISA and analyzer.  The activity of creatine kinase (CK) and lactate dehydrogenase (LDH) is estimated from the serum sample that was analyzed by ELISA and analyzer.Oxidative stress marker malondialdehyde (MDA) is expressed by reaction with thiobarbituric acid (TBA).</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>Iranian academic center for education culture and research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-11</approval_date>
        <contact_name>Research Ethics Committee of Tabriz University</contact_name>
        <contact_address>Unit 7, Omid Apartment 7, 5 Jannatt Alley, Janet St., Matin St., Rodaki St Orumieh West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
