<?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>IRCT20180218038785N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-15</date_registration>
      <primary_sponsor>Deputy of Research and Technology Development of Tabriz University</primary_sponsor>
      <public_title>Effects of  pilates training and turmeric supplementation on SIRT1, Klotho gene and Quality of life</public_title>
      <acronym></acronym>
      <scientific_title>Effects of 12 weeks of pilates training and turmeric supplementation on SIRT1, Klotho gene and Quality of life in middle-aged Overweight females</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29701</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Prevention, Randomization description: Using random numbers table, individuals were grouped into four groups, Blinding description: Blinding is carried out in the distribution of turmeric and placebo capsules so that the third person (researcher assistant) will distribute the capsules and and the participants and researchers do not know if they are receiving capsules of turmeric or placebo.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Aging.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (training) : Participate in 12 weeks of Pilates training (3 sessions per week with intensity of 40 -70 % maximum heart rate). Intervention 2: Intervention group (supplement): Daily consumption of three tablets of 700 mg turmeric, 20 min after meal. Intervention 3: Intervention group ( training-supplement): Participate in 12 weeks of Pilates training (3 sessions per week with intensity of 40 -70 % maximum heart rate) and daily consumption of three tablets of 700 mg turmeric, 20 min after meal. Intervention 4: Control group: daily consumption of three placebo tablets of 700 mg starch, 20 min after meal.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Abuse is possible</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rahele Dolgari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 36, Aliabadi Ave., Ansarifard St., Khayam St.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5184836546</zip>
        <telephone>+98 41 3289 4793</telephone>
        <email>R_Dolgari@yahoo.com</email>
        <affiliation>The University of Tabriz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ramin Amirsasan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Khomeini St.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166616471</zip>
        <telephone>+98 41 3339 3255</telephone>
        <email>amirsasan@tabrizu.ac.ir</email>
        <affiliation>The University of Tabriz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range of 35 to 55 years
Being Overweight( BMI: 25-30 kg/m²)
Without regular physical activity
No drug and supplementation
Having menstrual period</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>illness
allergy to spices
Unwillingness or person's cooperation</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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (training) : Participate in 12 weeks of Pilates training (3 sessions per week with intensity of 40 -70 % maximum heart rate)</i_keyword>
      <i_keyword>Intervention group (supplement): Daily consumption of three tablets of 700 mg turmeric, 20 min after meal.</i_keyword>
      <i_keyword>Intervention group ( training-supplement): Participate in 12 weeks of Pilates training (3 sessions per week with intensity of 40 -70 % maximum heart rate) and daily consumption of three tablets of 700 mg turmeric, 20 min after meal.</i_keyword>
      <i_keyword>Control group: daily consumption of three placebo tablets of 700 mg starch, 20 min after meal.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sirtuin1. Timepoint: Before and after the intervention (3 month later). Method of measurement: Sirtuin 1 content will be measured by using Human Sirtuin1 ELISA kit, made by Shanghay Crystal D company.</prim_outcome>
      <prim_outcome>Serum Klotho gene. Timepoint: Before and after the intervention (3 month later). Method of measurement: Human Klotho ELISA kit, made by Shanghay Crystal D company.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before and after the intervention (3 month later). Method of measurement: Quality of life questionare.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: Before and after intervention (3 month later). Method of measurement: With Omron Digital Scale.</sec_outcome>
      <sec_outcome>Body fat percent. Timepoint: Before and after intervention (3 month later). Method of measurement: Using body composition analyzer.</sec_outcome>
      <sec_outcome>Fat-free mass. Timepoint: Before and after intervention (3 month later). Method of measurement: Using body composition analyzer.</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>Deputy of Research and Technology Development of Tabriz University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-05</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>No 2 building, Tabriz University of Medical Sciences,Golgasht St, Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
