<?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>IRCT20220518054903N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-05</date_registration>
      <primary_sponsor>Gilan Faculty of Physical Education and Sports Sciences</primary_sponsor>
      <public_title>Interactive effect of Pilates training and nano-curcumin on fatty liver disease</public_title>
      <acronym></acronym>
      <scientific_title>The interactive effect of Pilates training and nano-curcumin supplementation on body composition and selected indices of non-alcoholic fatty liver disease in obese and overweight females</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63622</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: The participants are divided into two groups, supplement and placebo, and they do not know which one will receive the supplement and which one will receive the placebo.
Nanocurcumin supplement is available in the form of orange jelly capsules. The placebo capsules will be prepared in the same colour. The capsules will be removed from the strips of the manufacturing company and will be given to the participants in the same package as the placebo capsules. In addition, the subjects take the supplements at home and do not see how other people use them.</study_design>
      <phase>3</phase>
      <hc_freetext>Non Alcoholic Fatty Liver.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Pilates-curcumin group for 8 weeks and 3 days a week for 1 hour participating in a selected activity from Pilates exercises and daily consumption of two 40 mg nanocurcumin capsules produced by Exsir-Nano Sina company. Intervention 2: Control group:  Pilates-placebo group for 8 weeks and 3 days a week for 1 hour participating in a selected activity from Pilates exercises and daily consumption of two 40 mg capsules of corn starch (placebo).</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>Ebrahimi Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Persian Gulf Highway (km 5 of the Rasht-Qazvin road), Gilan University Complex</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613776</zip>
        <telephone>+98 13 3369 0255</telephone>
        <email>maryam.ebrahimi@guilan.ac.ir</email>
        <affiliation>Gilan Faculty of Physical Education and Sports Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ebrahimi Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Persian Gulf Highway (km 5 of the Rasht-Qazvin road), Gilan University Complex</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613776</zip>
        <telephone>+98 13 3369 0255</telephone>
        <email>maryam.ebrahimi@guilan.ac.ir</email>
        <affiliation>Gilan Faculty of Physical Education and Sports Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Non-alcoholic fatty liver disease patients
being Overweight or obese (WHR&gt;0.85, BMI&gt;25)</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>participating in a regular exercise program for the past 6 months
Presence of musculoskeletal injury
sensitivity to turmeric and curcumin
Consumption of dietary supplements in the last 3 months
smoking and alcohol
Taking drugs that lower blood glucose, blood lipids and anti-inflammatory drugs and any drugs that affect liver function
Other liver diseases and diabetes, cancer, cardiovascular disease and thyroid disorders
pregnancy or breastfeeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>کبد چرب غیر الکلی</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Pilates-curcumin group for 8 weeks and 3 days a week for 1 hour participating in a selected activity from Pilates exercises and daily consumption of two 40 mg nanocurcumin capsules produced by Exsir-Nano Sina company.</i_keyword>
      <i_keyword>Control group:  Pilates-placebo group for 8 weeks and 3 days a week for 1 hour participating in a selected activity from Pilates exercises and daily consumption of two 40 mg capsules of corn starch (placebo)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The degree of hepatic steatosis. Timepoint: 48 hours before and after the intervention. Method of measurement: Fibroscan machine made in Germany using abdominal elastography method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body fat percentage. Timepoint: 48 hours before and after the intervention. Method of measurement: Lafayette caliper made in America with Jackson and Pollock three-point method.</sec_outcome>
      <sec_outcome>BODY MASS INDEX. Timepoint: 48 hours before and after the intervention. Method of measurement: Height and weight measurement from Seca model 220 scale made in Germany and put in BMI formula.</sec_outcome>
      <sec_outcome>Visceral fat. Timepoint: 48 hours before and after the intervention. Method of measurement: meter reading.</sec_outcome>
      <sec_outcome>Serum concentration of liver enzymes. Timepoint: 48 hours before and after the intervention. Method of measurement: using the Biorex Fars kit, made in Iran and with an auto-analyzer device.</sec_outcome>
      <sec_outcome>Lipid profile. Timepoint: 48 hours before and after the intervention. Method of measurement: using the Biorex Fars kit, made in Iran and with an auto-analyzer 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>Gilan Faculty of Physical Education and Sports Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-13</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Persian Gulf Highway, km 5 Qazvin Road, Guilan University Complex Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
