<?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>IRCT20120525009856N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-13</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the synergist effect of probiotic and vitamin D in obesity</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of probiotic and 25OHD3  with  low-calorie diet on satiety and hunger hormones and vitamin D in obese people</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29748</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individual randomization with out layering, Four blocks randomized
Blocks will determined daily and write on paper
Selecting randomized blocks will done by somebody except researcher, Blinding description: The appearance of yogurts are the same
The main investigator will  not be aware of yogurt's content and the group which subjects are in.
The person who analyze date will be unaware of the group which  each subject belong.</study_design>
      <phase>3</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: low calorie diet and 100 g/day yogurt enriched with 1000 IU 25OHD3. Intervention 2: The second intervention group: low calorie diet and 100 g/day probiotic yogurt enriched with 1000 IU 25OHD3. Intervention 3: The third intervention group: low calorie diet and 100 g/day probiotic yogurt. Intervention 4: The control group: low calorie diet and 100 g/day traditional yogurt.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shima Hajipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Public Health faculty, Next to the Farabi Hospital, Dolat Ababd blvd, Isar Square, Imam Hosein Exp</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 83 1826 2005</telephone>
        <email>shima.hajipour.1t@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Yahya Pasdar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Public Health faculty, Next to the Farabi Hospital, Dolat Ababd blvd, Isar Square, Imam Hosein Exp</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 83 1826 2005</telephone>
        <email>yahya.pasdar@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to lose weight
Age between 18 and 60
Body mass index (BMI) between 29 and 51
Filling the consent form of the present project
Absence of associated co-morbidities (insulin dependent diabetes, chronic kidney disease, cancer and anemia)
Absence of breast-feeding, pregnancy or menopause
No history of hormone disorders including: hypothyroid, hyperthyroid, polycystic ovary syndrome (PCOS), breast and ovary cyst
No intake of vitamin D for 1 months before the study initiation
No antibiotic treatment for the last 1 month
No intake of probiotic, prebiotic and synbiotic supplement and/ or probiotic, prebiotic and synbiotic enriched products 1 month before the study initiation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Individuals who had allergy to yogurt
Individuals who use certain regimens or weight loss regimens
Individuals who use any kind of vitamin supplements
Individuals who use any kind of weight loss drug or supplement
women who use contraceptive drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: low calorie diet and 100 g/day yogurt enriched with 1000 IU 25OHD3</i_keyword>
      <i_keyword>The second intervention group: low calorie diet and 100 g/day probiotic yogurt enriched with 1000 IU 25OHD3</i_keyword>
      <i_keyword>The third intervention group: low calorie diet and 100 g/day probiotic yogurt</i_keyword>
      <i_keyword>The control group: low calorie diet and 100 g/day traditional yogurt.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>25(OH)D3. Timepoint: In base line (before intervention) and 10 months after the beginning of intervention. Method of measurement: By using ELISA Kit.</prim_outcome>
      <prim_outcome>Ghrelin hormone. Timepoint: In base line (before intervention) and 10 months after the beginning of intervention. Method of measurement: By using ELISA Kit.</prim_outcome>
      <prim_outcome>Peptid YY hormone. Timepoint: In base line (before intervention) and 10 months after the beginning of intervention. Method of measurement: By using ELISA Kit.</prim_outcome>
      <prim_outcome>GLP-1 hormone. Timepoint: In base line (before intervention) and 10 months after the beginning of intervention. Method of measurement: By using ELISA Kit.</prim_outcome>
      <prim_outcome>Waist Circumference. Timepoint: In base line (before intervention) and 10 months after the beginning of intervention. Method of measurement: In term of centimeter by Tape measure.</prim_outcome>
      <prim_outcome>Body Fat Mass. Timepoint: In base line (before intervention) and 10 months after the beginning of intervention. Method of measurement: in term of kg, by using body analyzer instrument.</prim_outcome>
      <prim_outcome>Hip Circumference. Timepoint: In base line (before intervention) and 10 months after the beginning of intervention. Method of measurement: In term of centimeter by Tape measure.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum LDL. Timepoint: before and after 10 weeks. Method of measurement: by using  Friedewald equation.</sec_outcome>
      <sec_outcome>Serum HDL. Timepoint: before and after 10 weeks. Method of measurement: by using biochemical kits (mono bind ELISA kit).</sec_outcome>
      <sec_outcome>Serum fasting blood sugar. Timepoint: before and after 10 weeks. Method of measurement: by using biochemical kits (mono bind ELISA kit).</sec_outcome>
      <sec_outcome>Serum total cholostrol. Timepoint: before and after 10 weeks. Method of measurement: by using biochemical kits (mono bind ELISA kit).</sec_outcome>
      <sec_outcome>Serum Total triglycerides. Timepoint: before and after 10 weeks. Method of measurement: by using biochemical kits (Monobind ELISA kit).</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>Medical univercity of kermanshah</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-28</approval_date>
        <contact_name>Kermanshah University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Deputy of Research and Technology, Building No. 2 of Kermanshah University of Medical Sciences, Naft Square, Shahid Beheshti blvd Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
