<?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>IRCT20200929048876N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-08</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Diet and intestinal microbiota alterations</public_title>
      <acronym></acronym>
      <scientific_title>Assessment and comparison of the effects of two types of low calorie low carbohydrate and low fat diets on intestinal microbiota changes and its association with some of metabolic factors alterations in obese women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53223</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: Blocked randomization will be used as two groups with 4-number blocks including 5 participant in each group. randomization unit is person and we will use random allocation software for this purpose. random coded boxes will be used for concealment. At this method, cans with similar weight, shape and color which are numbered according to the random sequence will be used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention and control group: From the total daily calorie needs, 500 kcal per day will be reduce for 0.5 kg weight reduction in each patient. In low fat diet 20% of total daily calorie will receive from fat (with emphasis on mono and poly- unsaturated plant fatty acids), 15% from protein and 65% from carbohydrates. Intervention 2: Control and intervention group: From the total daily calorie needs, 500 kcal per day will be reduce for 0.5 kg weight reduction in each patient. In low carbohydrate diet 20% of total daily calorie will receive from carbohydrate, 25% from protein and 55% from fats (with emphasis on mono and poly- unsaturated plant fatty acids).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
without participant name

When:
After study final

To whom:
All person

Conditions:
All person

Where to obtain:
Zanjan University of Medical Sciences, Deputy of Research and Thechnology

How to obtain:
straight referee to Deputy of Research and Technology of Zanjan University of Medical Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mahnaz Karbalaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valie-Asr Hospital, Shariati St</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956184</zip>
        <telephone>+98 24 3315 6300</telephone>
        <email>karbalaei.mahnaz@yahoo.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Seyedeh Neda Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mahdavi Blv., 13th St.</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956184</zip>
        <telephone>+98 24 3315 6300</telephone>
        <email>neda.mousavi@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Body mass index equal or higher than 30
female
ages of 18 to 50 year</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention and control group: From the total daily calorie needs, 500 kcal per day will be reduce for 0.5 kg weight reduction in each patient. In low fat diet 20% of total daily calorie will receive from fat (with emphasis on mono and poly- unsaturated plant fatty acids), 15% from protein and 65% from carbohydrates.</i_keyword>
      <i_keyword>Control and intervention group: From the total daily calorie needs, 500 kcal per day will be reduce for 0.5 kg weight reduction in each patient. In low carbohydrate diet 20% of total daily calorie will receive from carbohydrate, 25% from protein and 55% from fats (with emphasis on mono and poly- unsaturated plant fatty acids).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight alterations. Timepoint: baseline and after 6 weeks. Method of measurement: scale.</prim_outcome>
      <prim_outcome>Fasting blood sugar alterations. Timepoint: baseline and after 6 weeks. Method of measurement: autoanalyzer setting.</prim_outcome>
      <prim_outcome>Fasting triglyceride alterations. Timepoint: baseline and after 6 weeks. Method of measurement: autoanalyzer setting.</prim_outcome>
      <prim_outcome>Total cholesterol alterations. Timepoint: baseline and after 6 weeks. Method of measurement: autoanalyzer setting.</prim_outcome>
      <prim_outcome>LDL.C cholesterol alterations. Timepoint: baseline and after 6 weeks. Method of measurement: autoanalyzer setting.</prim_outcome>
      <prim_outcome>HDL.C cholesterol alterations. Timepoint: baseline and after 6 weeks. Method of measurement: autoanalyzer setting.</prim_outcome>
      <prim_outcome>Waist circumference alterarions. Timepoint: baseline and after 6 weeks. Method of measurement: centimeter.</prim_outcome>
      <prim_outcome>Intestinal microbiota alterations. Timepoint: baseline and after 6 weeks. Method of measurement: autoanalyzer setting.</prim_outcome>
      <prim_outcome>Blood pressure alterations. Timepoint: baseline and after 6 weeks. Method of measurement: autoanalyzer setting.</prim_outcome>
      <prim_outcome>C-reactive protein alterations. Timepoint: baseline and after 6 weeks. Method of measurement: ELIZA kit.</prim_outcome>
      <prim_outcome>Serum insulin alterations. Timepoint: baseline and after 6 weeks. Method of measurement: ELIZA kit.</prim_outcome>
      <prim_outcome>Hip circumference alterations. Timepoint: baseline and after 6 weeks. Method of measurement: centimeter.</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-06</approval_date>
        <contact_name>Ethic committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Azadi Blv, Zanjan University of Medical Sciences Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
