<?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>IRCT20131228015968N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-03</date_registration>
      <primary_sponsor>Vice chancellor for research, Shahid Beheshti University of Medical sciences- School of Nutrition</primary_sponsor>
      <public_title>The effect of probiotic supplementation on obesity</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Probiotic Supplementation on Anthropometric, Body composition, Appetite, Eating Behavior, plasma level of Leptin , Neuropeptide Y and Oxytocin in Obese Women with  Food addiction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38557</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, participants were classified into two groups with obesity grade A (30-34.9) and obesity grade 2 (34.9-39.9) by stratified blocked randomization method and based on BMI and randomly assigned to One of the groups receiving the supplement is a probiotic or placebo group. Separate randomization is done within each group. The size of the blocks is 4, with two assignments to the intervention group (A) and two allocations to the placebo group (B). There are 6 different permutations of AABB, ABAB, BBAA, BABA, ABBA, BAAB, Blinding description: Prior to the beginning of the study, the canisters containing the capsules are coded by individuals other than the research team, A and B, so that the knowledge of the type of capsules received by each group is not known to the researcher. Since this study is double blind, the subjects , the researchers have no information about the individuals located in the studied and control groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group received daily two probiotic capsules containing (Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium lactis, Bifidobacterium langum, Lactobacillus rhominosus and Lactobacillus rotiria (every 12 hours) with microbial load 2* 10^9 for 12 weeks manufactured in Tak Gene, Iran. Intervention 2: Control group: received daily two placebo capsules containing 300 mg of starch every 12 hours for 12 weeks. manufactured in Zahravi Pharmaceutical Company. The placebo is completely similar to the probiotic supplement in terms of its appearance.</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 Undecided - It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Narmaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO. 7, Hafezi (Arghavan) Ave., Farahzadi Blvd, Qods (Gharb) twon, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619573</zip>
        <telephone>+98 21 2235 7483</telephone>
        <email>E.narmaki65@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atoosa Saidpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, Hafezi (Arghavan) Ave., Farahzadi Blvd., Qods (Gharb) twon, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619573</zip>
        <telephone>+98 21 2235 7384</telephone>
        <email>Atoosa.saidpour@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Body Mass Index 30-39.99
The desire to participate in the study
Confirmation of food addiction after obtaining the necessary points from the relevant questionnaire
Being in the age range of 20-50 years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a Weight loss diet in the last two months
Pregnancy or lactation
Menopause
Continuous use (more than once a week) of vitamin and mineral supplements in the past month
Use of any type of antibiotic in the last three weeks
Use of weight loss and appetite suppressants
Sports activity that lasted more than three weeks from the start
Cancer, cardiovascular disease, diabetes
Acute gastrointestinal disease
Chronic kidney or liver disease, with the exception of non-alcoholic fatty liver
Infectious diseases up to 1 month before the start of the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity due to excess calories</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 received daily two probiotic capsules containing (Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium lactis, Bifidobacterium langum, Lactobacillus rhominosus and Lactobacillus rotiria (every 12 hours) with microbial load 2* 10^9 for 12 weeks manufactured in Tak Gene, Iran</i_keyword>
      <i_keyword>Control group: received daily two placebo capsules containing 300 mg of starch every 12 hours for 12 weeks. manufactured in Zahravi Pharmaceutical Company. The placebo is completely similar to the probiotic supplement in terms of its appearance</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: Before intervention, after 6 Weeks of intervention and after 12 Weeks of intervention. Method of measurement: Seca scale.</prim_outcome>
      <prim_outcome>Body Mass Index. Timepoint: Before intervention, after 6 Weeks of intervention and after 12 Weeks of intervention. Method of measurement: Calculation (kg/m2).</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: Before intervention, after 6 Weeks of intervention and after 12 Weeks of intervention. Method of measurement: Meter strip.</prim_outcome>
      <prim_outcome>Fat Mass. Timepoint: Before intervention, after 6 Weeks of intervention and after 12 Weeks of intervention. Method of measurement: Bio Impedance Analyzer.</prim_outcome>
      <prim_outcome>Fat Free Mass. Timepoint: Before intervention, after 6 Weeks of intervention and after 12 Weeks of intervention. Method of measurement: Bio Impedance Analyzer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum level of Leptin. Timepoint: Before intervention and after 12 weeks of intervention. Method of measurement: Elisa.</sec_outcome>
      <sec_outcome>Serum Neuropeptide Y. Timepoint: Before intervention and after 12 weeks of intervention. Method of measurement: Elisa.</sec_outcome>
      <sec_outcome>Appetite. Timepoint: Before intervention and after 12 weeks of intervention. Method of measurement: Simple appetite questionnaire.</sec_outcome>
      <sec_outcome>Serum level of Oxytocin. Timepoint: Before intervention and after 12 weeks of intervention. Method of measurement: Elisa.</sec_outcome>
      <sec_outcome>Eating behavior. Timepoint: Before intervention and after 12 weeks of intervention. Method of measurement: The Three-Factor Eating Questionnaire.</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>Vice chancellor for research, Shahid Beheshti University of Medical sciences- School of Nutrition</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-31</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical sciences</contact_name>
        <contact_address>No. 7, Hafezi (Arghavan) Ave., Farahzadi Ave., Shahrake Qods(Gharb) town, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-31</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical sciences</contact_name>
        <contact_address>No. 7, Hafezi (Arghavan) Ave., Farahzadi Ave., Shahrake Qods(Gharb) town, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
