<?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>IRCT20100209003320N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-02</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of prebiotic supplementation and calorie restriction in major depressive disorder</public_title>
      <acronym></acronym>
      <scientific_title>The effects of a weight loss diet with or without prebiotic supplementation on anthropometric measures, metabolic and inflammatory status, gut permeability, endotoxemia and depression status in obese women with major depression disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32972</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: From among the patients who volunteer to participate in the study, 48 individuals will be selected by simple randomization. Then by using the Random Allocation Software, the subjects will be allocated into either prebiotic or placebo group, stratified by depression severity and BMI, Blinding description: In this study, the main investigators (including the student, and her supervisor and adviser professors) as well as the patients will be blinded to the type of the supplement (prebiotic or placebo) received by each group. The person responsible for preparing the supplement sachets (who is completely unrelated to the study) will be asked to assign a three digit code to each of the two powders (prebiotic and placebo), and keep the codes for himself until the end of the study and data analyses.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Major depressive disorder, mild. Condition 2: Major depressive disorder, moderate.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in this group will receive weight loss diet and prebiotic supplements for 8 weeks. Prebiotic supplement is a sachet containing 10 grams of inulin (a product by Sensus Co.and made in The Netherlands) which will be dissolved in a glass of water and used once a day with lunch. Intervention 2: Control group: Patients in this group will receive weight loss diet and placebo for 8 weeks.Placebo is a sachet containing 10 grams of maltodextrin (a product by FIC Co. and made in China)which will be dissolved in a glass of water and used once a day with lunch.</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>Elnaz Vaghef-Mehrabany</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nutrition and Food Sciences, Attar Neyshabouri Av., Golgasht St.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 7582</telephone>
        <email>elnaz.vaghef@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mehrangiz Ebrahimi Mamagani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nutrition and Food Sciences, Attar Neyshabouri Av., Golgasht St.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 7582</telephone>
        <email>ebrahimimamagani@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Non-menopausal women aged 20-50 years
Body Mass Index (BMI) range: 30-40 Kg/m2
Suffering from mild to moderate depression based on DSM-V (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) criteria, as diagnosed by a psychiatrist
willingness to participate in the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy or lactation
Co-morbidity with other major psychological or neurological diseases including psychosis, multiple sclerosis (MS), bipolar disorder
Suffering from thyroid dysfunctions
Drug abuse
Smoking
A history of following particular diets
Using synthetic or herbal drugs for weight loss
Changes in type or dosage of any other medications or nutritional supplements, during the study
Using fiber supplements or taking more than 25 grams of dietary fiber per day
Regular use of prebiotic or probiotic products or supplements, or antibiotic drugs during 2 months prior to the study or during the study
Any significant events during the study, which might affect the patient's psychological health</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F33.0</hc_code>
      <hc_code>F33.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, recurrent, mild</hc_keyword>
      <hc_keyword>Major depressive disorder, recurrent, moderate</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: Patients in this group will receive weight loss diet and prebiotic supplements for 8 weeks. Prebiotic supplement is a sachet containing 10 grams of inulin (a product by Sensus Co.and made in The Netherlands) which will be dissolved in a glass of water and used once a day with lunch.</i_keyword>
      <i_keyword>Control group: Patients in this group will receive weight loss diet and placebo for 8 weeks.Placebo is a sachet containing 10 grams of maltodextrin (a product by FIC Co. and made in China)which will be dissolved in a glass of water and used once a day with lunch.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anthropometric measures. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of height and weight without shoes and with minimum clothes on, by Seca stadiometer and scale, respectively. Measurement of waist and hip circumferences by a tape measure. Calculation of waist to hip ratio (WHR) by dividing waist circumference by hip circumference, and body mass index (BMI) by dividing weight (Kg) by height squared (m2).</prim_outcome>
      <prim_outcome>Body composition. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Bioelectrical Impedance Analysis (BIA) to determine Fat mass (FM), Fat free mass (FFM), and Body water (BW).</prim_outcome>
      <prim_outcome>Resting metabolic rate. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Indirect calorimetry.</prim_outcome>
      <prim_outcome>Gut permeability. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of Serum Zonulin by ELISA method.</prim_outcome>
      <prim_outcome>Endotoxemia. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of serum lipopolysaccharide (LPS) by ELISA.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: stethoscope.</prim_outcome>
      <prim_outcome>Blood glucose. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic method.</prim_outcome>
      <prim_outcome>Lipid profile. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of total cholesterol, HDL-cholesterol and triglyceride through enzymatic methods and calculation of LDL-cholesterol by Friedewald equation.</prim_outcome>
      <prim_outcome>Inflammatory indices. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of serum hs-CRP by immunoturbidimetry, and serum TNF-a and IL-10 by ELISA.</prim_outcome>
      <prim_outcome>State-trait anxiety. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Spielberger State-Trait Anxiety Inventory (STAI-Y).</prim_outcome>
      <prim_outcome>Depression severity. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Beck Depression Inventory (BDI-II).</prim_outcome>
      <prim_outcome>Depression remission. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Hamilton Depression Rating Scale (HDRS).</prim_outcome>
      <prim_outcome>Psychological well-being. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: WHO-5 questionnaire.</prim_outcome>
      <prim_outcome>Serum brain-derived neurotrophic factor (BDNF). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Serum Monocyte Chemoattractant Protein-1 (MCP-1). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Serum Toll-like receptor 4 (TLR_4). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Serum Tryptophan. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Serum kynurenine. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA.</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>2018-05-21</approval_date>
        <contact_name>The Research Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Attar Neyshabouri Av., Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-14</approval_date>
        <contact_name>The Research Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Attar Neyshabouri Av., Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-11</approval_date>
        <contact_name>The Research Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Attar Neyshabouri Av., 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>
