<?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>IRCT20130227012628N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-21</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of probiotic-enriched kefir drinks on elderly overweight and obese participants</public_title>
      <acronym></acronym>
      <scientific_title>The effect of probiotic-enriched kefir compared to regular kefir drinks on stress oxidative and inflammatory markers in elderly overweight and obese participants: a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68630</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: Before beginning the study, an outsider who is familiar with the randomization method prepares 4 blocks of random blocks, then randomly identifies the sequences and groups them in a closed envelope, named A, B, C, and D. After the individuals enter the study, the sealed envelopes containing the assigned group of participants will be opened for each participant based on the sequence determined by the person outside the study, Blinding description: The appearance of the kefir drinks in which they are packaged are quite similar. The drinks will be named with the Latin letters A and B. In the clinical phase of the study, the random allocation sequence is done with the same letters. Therefore, the researcher and all participants will be blinded to the intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>Elderly.</hc_freetext>
      <i_freetext>Intervention group: Group 1 receives the probiotic-enriched kefir drinks. Group 2 receives the kefir drink..</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>Mehran Nouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi street, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۱۵۳۶۷۵۵۰۰</zip>
        <telephone>+98 71 3725 1001</telephone>
        <email>mehran_nouri71@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Samadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah Al-Azam Hospital, after Sheikh Bahai, Mulla Sadra Street, Vanak Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915371</zip>
        <telephone>+98 21 81261</telephone>
        <email>samadi.mohammad@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Male gender
Age over 65 years
Body mass index above 25
Absence of chronic liver, kidney, diabetes, cardiovascular diseases, digestive disorders, chronic infectious diseases, severe neurological and psychological disorders and not taking antidepressants medicine
Not taking probiotic supplements within 2 months and antibiotics within the last 3 months
Not taking antioxidant supplements
Not regularly consuming alcohol (more than three units per week) and smoking</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Any changes in diet or medications
Unwillingness to continue studying
Unwanted side effects that improve by stopping the intervention, which will cause participants to withdraw from the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group 1 receives the probiotic-enriched kefir drinks. Group 2 receives the kefir drink.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: Before the study and 8 weeks after the start of the study. Method of measurement: Calorimetric method with Zelbio (Germany) kit with microplate reader device.</prim_outcome>
      <prim_outcome>Superoxide dismutase. Timepoint: Before the study and 8 weeks after the start of the study. Method of measurement: Calorimetric method with Zelbio (Germany) kit with microplate reader device.</prim_outcome>
      <prim_outcome>Catalase. Timepoint: Before the study and 8 weeks after the start of the study. Method of measurement: Calorimetric method with Zelbio (Germany) kit with microplate reader device.</prim_outcome>
      <prim_outcome>Glutathione peroxidase. Timepoint: Before the study and 8 weeks after the start of the study. Method of measurement: Calorimetric method with Zelbio (Germany) kit with microplate reader device.</prim_outcome>
      <prim_outcome>C-reactive protein. Timepoint: Before the study and 8 weeks after the start of the study. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) method with LDN (Germany) kit.</prim_outcome>
      <prim_outcome>Malondialdehyde. Timepoint: Before the study and 8 weeks after the start of the study. Method of measurement: Spectrophotometry method with Zelbio (Germany) kit.</prim_outcome>
      <prim_outcome>Interleukin-6. Timepoint: Before the study and 8 weeks after the start of the study. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) method with LDN (Germany) kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: Before the study and 8 weeks after the start of the study. Method of measurement: Scales.</sec_outcome>
      <sec_outcome>Height. Timepoint: Before the study and 8 weeks after the start of the study. Method of measurement: Non stretchable meter.</sec_outcome>
      <sec_outcome>Waist Circumference. Timepoint: Before the study and 8 weeks after the start of the study. Method of measurement: Non stretchable meter.</sec_outcome>
      <sec_outcome>Hip Circumference. Timepoint: Before the study and 8 weeks after the start of the study. Method of measurement: Non stretchable meter.</sec_outcome>
      <sec_outcome>Lipid profiles. Timepoint: Before the study and 8 weeks after the start of the study. Method of measurement: Commercial kits using an automatic autoanalyzer.</sec_outcome>
      <sec_outcome>Appetite score. Timepoint: Before the study and 8 weeks after the start of the study. Method of measurement: Visual appetite scale.</sec_outcome>
      <sec_outcome>Depression score. Timepoint: Before the study and 8 weeks after the start of the study. Method of measurement: Geriatric depression scale-15.</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>2023-02-06</approval_date>
        <contact_name>Research Ethic Committee of Bagiyatallah hospital</contact_name>
        <contact_address>Baqiyatallah Al-Azam Hospital, after Sheikh Bahai, Mulla Sadra Street, Vanak Square Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
