<?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>IRCT20191127045525N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-07</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Probiotic applications in obesity and related mood disorders</public_title>
      <acronym></acronym>
      <scientific_title>Effects of co-supplementation with probiotic and magnesium on components of microbiota-gut-brain axis including mood, intestinal barrier function and stool microbial populations in obese subjects with metabolic mood syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43823</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: By implementing block randomization method using blocks of four, eligible subjects will be randomly allocated to either intervention or control group. Allocation concealment will be conducted by application of sealed envelopes containing active or placebo, created by a colleague that is not involved with data gathering and participant evaluation, Blinding description: All active capsules and placebo will be the same in size, color, odor, taste and other related characteristics. Furthermore, the packaging will be the same  so neither data collectors and outcome assessors (that are the same in the present study) nor participants will be aware of the intervention type.</study_design>
      <phase>3</phase>
      <hc_freetext>Obesity with mood disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group will recieve 1 gram Capsule containing lactobacillus and bifidobacteria at dose of 3*10 9 CFU + one capsule containing 1 gram magnesium chloride providing 250 milligrams of elemental magnesium on a daily basis after one of main meals (preferably dinner). Intervention 2: Control group will receive two 1-gram capsules containing maldodextrin similar to those with active components based on color, shape, odor, weight, and packaging, on a daily basis after a main meal (preferably dinner).</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sepideh Mahboobi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>+98 71 3832 3281</telephone>
        <email>sepidmahboobi@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sepideh Mahboobi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>+98 71 3832 3281</telephone>
        <email>sepidmahboobi@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>ٌWilling to participate in the study
Age range of 18 to 50 years
Body Mass Index (BMI) ≥30 and waist circumference (WC) more than 85cm in women and 102 cm in men
Beck Depression Inventory (BDI) scores ranging between 17 to 40
Not taking probiotic supplements in the last 2 months and antibiotics in the last 3 months
Absence of chronic liver, kidney, cardiovascular, GI and infectious diseases as well as diabetes, and severe neurological and psychiatric disorders.
Not using anti-depressants
Not using antioxidants, omega-3 and magnesium supplements less than one month prior to study commencement
Not regular use of steroid and non-steroid anti-inflammatory drugs
No regular alcohol drinking or smoking, No opioid addiction
No history of heart attack, not being pregnant or intending pregnancy, not being in breastfeeding or menopausal states.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>pregnancy, any significant change in diet or physical activity, starting new drugs or antibiotics, and not intending to continue study protocols.</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>Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group will recieve 1 gram Capsule containing lactobacillus and bifidobacteria at dose of 3*10 9 CFU + one capsule containing 1 gram magnesium chloride providing 250 milligrams of elemental magnesium on a daily basis after one of main meals (preferably dinner)</i_keyword>
      <i_keyword>Control group will receive two 1-gram capsules containing maldodextrin similar to those with active components based on color, shape, odor, weight, and packaging, on a daily basis after a main meal (preferably dinner).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Beck Depression Inventory (BDI) score. Timepoint: Before commencement and after 12 weeks of intervention. Method of measurement: Beck Depression Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Beck Anxiety Inventory (BAI) score. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: Beck anxiety questionnaire.</sec_outcome>
      <sec_outcome>Plasma Zonulin Levels. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: ELIZA.</sec_outcome>
      <sec_outcome>Plasma Endotoxin. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: ELIZA.</sec_outcome>
      <sec_outcome>Some Stool Bacterial populations. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: Real time PCR.</sec_outcome>
      <sec_outcome>Waist. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: Tape meter.</sec_outcome>
      <sec_outcome>Weight. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: Body analyzer (Inbody).</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: Body analyzer (Inbody).</sec_outcome>
      <sec_outcome>Fat mass. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: Body analyzer (Inbody).</sec_outcome>
      <sec_outcome>Fat free mass. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: Body analyzer (Inbody).</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: qol-12 questionnaire.</sec_outcome>
      <sec_outcome>Depression . stress and anxiety scores. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: DASS anxiety, stress &amp; depression questionnaire.</sec_outcome>
      <sec_outcome>Fasting serum cortisol. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: ELIZA.</sec_outcome>
      <sec_outcome>Fasting blood glucose. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: Autoanalyzer.</sec_outcome>
      <sec_outcome>Fasting serum insulin. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: ELIZA.</sec_outcome>
      <sec_outcome>Homeostatic Model Assessment for Insulin Resistance (HOMAIR). Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: FORMULA.</sec_outcome>
      <sec_outcome>Quantitative insulin-sensitivity check index (QUICKI). Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: FORMULA.</sec_outcome>
      <sec_outcome>C-reactive protein. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: ELIZA.</sec_outcome>
      <sec_outcome>Serum magnesium. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: Autoanalyzer.</sec_outcome>
      <sec_outcome>Montreal Cognitive Assessment score (MoCA). Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-03</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand street Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-30</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand street Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
