<?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>IRCT20141004019397N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-10</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of curcumin supplementation with High-intensity interval training on serum Irisin levels and lipid profile in non-active obese women "</public_title>
      <acronym></acronym>
      <scientific_title>The effect of curcumin supplementation with High-intensity interval training on serum Irisin levels and lipid profile in non-active obese women: a randomized clinical trial "</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57415</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Factorial, Purpose: Health service research, Randomization description: After selecting the number of subjects, We assign a number from 1 to 40 to each of them, then we enter the site https://www.random.org/sequences, and by entering the smallest and largest number as well as the number of groups, the site itself automatically divides people into 4 groups.</study_design>
      <phase>3</phase>
      <hc_freetext>obesity women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The curcumin supplement group will take one 80 mg nanomicillin curcumin capsule daily for eight weeks before lunch with a glass of water. Intervention 2: Intervention group: Exercise and curcumin supplementation group for eight weeks of intense interval training in the form of running and walking at 80 to 100% heart rate reserve and will take one 80 mg nanomicillin curcumin capsule daily before lunch with a glass of water. Intervention 3: Intervention group: Exercise and placebo group  in addition to daily exercise training protocol dextrose 80 mg capsules before lunch and a glass of water will be consumed. Intervention 4: Control group: Dextrose 80 mg capsules once daily before lunch and a glass of water will be consumed.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The results of the research will be shared after publication

When:
After printing the results

To whom:
Academic and scientific researchers

Conditions:
research centers

Where to obtain:
Via email and contact number

How to obtain:
Immediately after printing

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bahram Jamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dept. of Basic Sciences, Paramedical School, Tabriz University of Medical Sciences, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5165938634</zip>
        <telephone>+98 41 3336 1900</telephone>
        <email>jamalib@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bahram Jamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dept. of Basic Sciences, Paramedical School, Tabriz University of Medical Sciences, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5165938634</zip>
        <telephone>+98 41 3336 1900</telephone>
        <email>jamalib@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged 30 to 35 years,
obese (BMI greater or equal to 30),
lack of regular exercise during the last two years,
an impaired lipid profile,
not taking drugs and supplements</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having thyroid, cardiovascular, respiratory, hypertension, diabetes, metabolic syndrome,
pregnancy and lactation
as well as allergies to spices
unwillingness to cooperate</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight and obesity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The curcumin supplement group will take one 80 mg nanomicillin curcumin capsule daily for eight weeks before lunch with a glass of water.</i_keyword>
      <i_keyword>Intervention group: Exercise and curcumin supplementation group for eight weeks of intense interval training in the form of running and walking at 80 to 100% heart rate reserve and will take one 80 mg nanomicillin curcumin capsule daily before lunch with a glass of water.</i_keyword>
      <i_keyword>Intervention group: Exercise and placebo group  in addition to daily exercise training protocol dextrose 80 mg capsules before lunch and a glass of water will be consumed.</i_keyword>
      <i_keyword>Control group: Dextrose 80 mg capsules once daily before lunch and a glass of water will be consumed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The rate of change in plasma aerosin. Timepoint: At baseline and two days after the last training session. Method of measurement: Sunlong Biotech kits will be used to measure aerosin.</prim_outcome>
      <prim_outcome>Lipid profile changes. Timepoint: At baseline and two days after the last training session. Method of measurement: To measure lipid profile, it will be measured from Pars-Azmoon kits by ELISA method.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-05</approval_date>
        <contact_name>Research Ethics Committees of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Golgasht St., Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
