<?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>IRCT20100408003664N20</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-20</date_registration>
      <primary_sponsor>Nutritional Reseach Center of Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Ginger supplementation and high intensity Interval Training on metabolic status, serum irisin and anthropometric indices in obese men</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Ginger supplementation and high intensity Interval Training on metabolic status, serum irisin and anthropometric indices in obese men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29125</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples were selected using available methods and randomly assigned random blocks of 4 volumes to the study groups.A random sequence is generated using the STATA14 software.During the random assignment, individuals in the groups will be classified according to age and BMI variables, Blinding description: Samples were selected using available methods and randomly assigned random blocks of 4 volumes to the study groups. A random sequence is generated using the STATA14 software. During the random assignment, individuals in the groups will be classified according to age and BMI variables.</study_design>
      <phase>3</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Recipe daily 3 g ginger (three capsules of 1 g). Intervention 2: Intervention group: Ginger plus to HIIT Exercise (daily g3 ginger is as three capsules of 1 gram and HIIT exercise for 10 weeks a week, 3 sessions and a total of 30 sessions). Intervention 3: Intervention group: Practice HIIT plus to Placebo (3 g starch daily in the form of three capsules of 1 g  and a HIIT exercise for 3 weeks each week and a total of 30 sessions per week). Intervention 4: Control group: Placebo (3 g starch per day, 3 capsules per gram).</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 The final decision will be taken after the end of the study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad bakhshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Health and Nutrition school, Attare Neishabouri Avenue, Golgasht street, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 13 3332 4573</telephone>
        <email>Bakhshi.msh@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Bakhshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition Faculty, Tabriz University of Medical Sciences, Golgasht street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 13 3332 4573</telephone>
        <email>bakhshi.msh@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male gender
Desire to cooperate and sign a informed consent form after full knowledge of the goals and method of carrying out the study
Age group 20 to 35 years old
BMI  30-40   kg/m2</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Follow certain diets in the last 6 months
use of drugs glucose lowering agent, statins, glucocorticoids ... or food supplements
Participate in any regular sports activities
Smoking
Food allergies
People with diabetes, cardiovascular disease, respiratory disease, hyperthyroidism or hypothyroidism, kidney liver disease, digestive disease or other illnesses</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>Treatment - Other</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 group: Recipe daily 3 g ginger (three capsules of 1 g)</i_keyword>
      <i_keyword>Intervention group: Ginger plus to HIIT Exercise (daily g3 ginger is as three capsules of 1 gram and HIIT exercise for 10 weeks a week, 3 sessions and a total of 30 sessions)</i_keyword>
      <i_keyword>Intervention group: Practice HIIT plus to Placebo (3 g starch daily in the form of three capsules of 1 g  and a HIIT exercise for 3 weeks each week and a total of 30 sessions per week)</i_keyword>
      <i_keyword>Control group: Placebo (3 g starch per day, 3 capsules per gram)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total Cholesterol. Timepoint: Before the intervention and 10 weeks after starting. Method of measurement: Enzymatic method.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Before the intervention and 10 weeks after starting. Method of measurement: Enzymatic method.</prim_outcome>
      <prim_outcome>HDL-C. Timepoint: Before the intervention and 10 weeks after starting. Method of measurement: Enzymatic method.</prim_outcome>
      <prim_outcome>LDL-C. Timepoint: Before the intervention and 10 weeks after starting. Method of measurement: Formula.</prim_outcome>
      <prim_outcome>Glucose. Timepoint: Before the intervention and 10 weeks after starting. Method of measurement: Enzymatic method.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: Before the intervention and 10 weeks after starting. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>HOMA-IR. Timepoint: Before the intervention and 10 weeks after starting. Method of measurement: Formula.</prim_outcome>
      <prim_outcome>Irisin. Timepoint: Before the intervention and 10 weeks after starting. Method of measurement: ELYSA.</prim_outcome>
      <prim_outcome>Anthropometric Indicators. Timepoint: Before the intervention and 10 weeks after starting. Method of measurement: Metre.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Diet. Timepoint: Before the intervention, 5 weeks after it and 10 weeks after its start. Method of measurement: 3-day food record.</sec_outcome>
      <sec_outcome>Physical activity. Timepoint: Before the intervention and 10 weeks after starting. Method of measurement: Before the intervention and 10 weeks after it begins.</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>Nutritional Reseach Center of Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-03</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Science</contact_name>
        <contact_address>Tabriz University of Medical Science, Attar Neishabouri Avenue, Golgasht street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
