<?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>IRCT20230131057292N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-20</date_registration>
      <primary_sponsor>University of Tehran</primary_sponsor>
      <public_title>Comparison of the effect of combined exercise and consumption of three types of tea on overweight men</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of combined training and consumption of three types of tea on the serum levels of FGF21 and PGC1α in overweight and obese men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77470</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, patients will be selected by the method of random allocation law and using the principles of random sampling. So that after determining the sample size, people will be divided into four equal groups by lottery. The names of the candidates are written on separate sheets and placed in a container. Then, randomly, the sheets are removed from the container without replacement and the created sequence is recorded, and people are randomly placed in the intervention or control group, Blinding description: Both patients and health care workers and exercise professionals will be unaware of the patient's exposure. Each patient will be assigned an ID, based on which the desired intervention (helping with various types of tea) will be carried out during the research.</study_design>
      <phase>3</phase>
      <hc_freetext>Overweight and obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: combined exercises + green tea for 8 weeks and will perform 3 times of combined exercises every week. The combined exercises of each session include 10 minutes of warm-up (gentle running and stretching), the aerobic training program includes 20 minutes of running on the treadmill with an intensity of 60 to 80% of the maximum heart rate, and strength training includes 4 stationary movements with an intensity of 55 to 75 per repetition. The maximum is 3 sets with 8 to 12 repetitions and a rest interval of 60 seconds between each set and 2 minutes between each station. In addition, 2 servings of green tea in the amount of 2 grams dissolved in 240 ml of water are consumed every day. Intervention 2: Intervention group: combined exercises + white tea for 8 weeks and will do 3 times of combined exercises every week. The combined exercises of each session include 10 minutes of warm-up (gentle running and stretching), the aerobic training program includes 20 minutes of running on the treadmill with an intensity of 60 to 80% of the maximum heart rate, and strength training includes 4 stationary movements with an intensity of 55 to 75 per repetition. The maximum is 3 sets with 8 to 12 repetitions and a rest interval of 60 seconds between each set and 2 minutes between each station. In addition, 2 servings of white tea in the amount of 2 grams dissolved in 240 ml of water are consumed every day. Intervention 3: Intervention group: combined exercises + sour tea for 8 weeks and will do 3 times of combined exercises every week. The combined exercises of each session include 10 minutes of warm-up (gentle running and stretching), the aerobic training program includes 20 minutes of running on the treadmill with an intensity of 60 to 80% of the maximum heart rate, and strength training includes 4 stationary movements with an intensity of 55 to 75 per repetition. The maximum is 3 sets with 8 to 12 repetitions and a rest interval of 60 seconds between each set and 2 minutes between each station. In addition, 2 servings of sour tea in the amount of 2 grams dissolved in 240 ml of water are consumed every day. Intervention 4: Control group: They will do combined exercises 3 times a week for 8 weeks. The combined exercises of each session include 10 minutes of warm-up (gentle running and stretching), the aerobic training program includes 20 minutes of running on the treadmill with an intensity of 60 to 80% of the maximum heart rate, and strength training includes 4 stationary movements with an intensity of 55 to 75 per repetition. The maximum is 3 sets with 8 to 12 repetitions and a rest interval of 60 seconds between each set and 2 minutes between each station.</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>zahra Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehran, Islamic Republic</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439813117</zip>
        <telephone>+98 21 6111 8872</telephone>
        <email>zarahosseini@ut.ac.ir</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shima Mojtahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehran, Islamic Republic</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439813117</zip>
        <telephone>+98 21 6111 8872</telephone>
        <email>shmojtahedi@ut.ac.ir</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men aged between 30 and 50 years
Body mass index between 25 and 35 kg/m2
Inactivity (less than 30 minutes of sports activity per week)</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Taking any kind of medicine and food supplement
Performing surgery to reduce obesity
Consumption of alcoholic beverages and cigarettes
Subjects' unwillingness to continue the research protocols
Allergy to tea
Participating in sports activities other than the sports program of the present study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: combined exercises + green tea for 8 weeks and will perform 3 times of combined exercises every week. The combined exercises of each session include 10 minutes of warm-up (gentle running and stretching), the aerobic training program includes 20 minutes of running on the treadmill with an intensity of 60 to 80% of the maximum heart rate, and strength training includes 4 stationary movements with an intensity of 55 to 75 per repetition. The maximum is 3 sets with 8 to 12 repetitions and a rest interval of 60 seconds between each set and 2 minutes between each station. In addition, 2 servings of green tea in the amount of 2 grams dissolved in 240 ml of water are consumed every day.</i_keyword>
      <i_keyword>Intervention group: combined exercises + white tea for 8 weeks and will do 3 times of combined exercises every week. The combined exercises of each session include 10 minutes of warm-up (gentle running and stretching), the aerobic training program includes 20 minutes of running on the treadmill with an intensity of 60 to 80% of the maximum heart rate, and strength training includes 4 stationary movements with an intensity of 55 to 75 per repetition. The maximum is 3 sets with 8 to 12 repetitions and a rest interval of 60 seconds between each set and 2 minutes between each station. In addition, 2 servings of white tea in the amount of 2 grams dissolved in 240 ml of water are consumed every day.</i_keyword>
      <i_keyword>Intervention group: combined exercises + sour tea for 8 weeks and will do 3 times of combined exercises every week. The combined exercises of each session include 10 minutes of warm-up (gentle running and stretching), the aerobic training program includes 20 minutes of running on the treadmill with an intensity of 60 to 80% of the maximum heart rate, and strength training includes 4 stationary movements with an intensity of 55 to 75 per repetition. The maximum is 3 sets with 8 to 12 repetitions and a rest interval of 60 seconds between each set and 2 minutes between each station. In addition, 2 servings of sour tea in the amount of 2 grams dissolved in 240 ml of water are consumed every day.</i_keyword>
      <i_keyword>Control group: They will do combined exercises 3 times a week for 8 weeks. The combined exercises of each session include 10 minutes of warm-up (gentle running and stretching), the aerobic training program includes 20 minutes of running on the treadmill with an intensity of 60 to 80% of the maximum heart rate, and strength training includes 4 stationary movements with an intensity of 55 to 75 per repetition. The maximum is 3 sets with 8 to 12 repetitions and a rest interval of 60 seconds between each set and 2 minutes between each station.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum levels of PGC1α. Timepoint: 48 hours before and after the last training session after 12 hours of fasting. Method of measurement: Using the human ELISA diagnostic kit related to the variable.</prim_outcome>
      <prim_outcome>Serum levels of FGF21. Timepoint: 48 hours before and after the last training session after 12 hours of fasting. Method of measurement: 48 hours before and after the last training session after 12 hours of fasting.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight changes. Timepoint: At the beginning of the study (before the start of the intervention) and 8 weeks after the start of the research. Method of measurement: scale.</sec_outcome>
      <sec_outcome>Waist to hip ratio. Timepoint: At the beginning of the study (before the start of the intervention) and 8 weeks after the start of the research. Method of measurement: Waist to hip ratio.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: At the beginning of the study (before the start of the intervention) and 8 weeks after the start of the research. Method of measurement: Bioelectrical impedance device.</sec_outcome>
      <sec_outcome>Fat index. Timepoint: At the beginning of the study (before the start of the intervention) and 8 weeks after the start of the research. Method of measurement: Bioelectrical impedance device.</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>University of Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-28</approval_date>
        <contact_name>Ethics Committee in Research, Faculty of Physical Education and Sports Sciences, University of Tehra</contact_name>
        <contact_address>Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar St., Tehran, Islamic Republic Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
