<?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>IRCT2016102830538N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-12-20</date_registration>
      <primary_sponsor>Vice chancellor of research, International Campus, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of very low carbohydrate and high fat diet on gastric cancer</public_title>
      <acronym></acronym>
      <scientific_title>A clinical trial comparing a very low carbohydrate MCT oil supplemented diet with standard diet on prognostic biomarkers and indicators related to cachexia in gastric adenocarcinoma patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24231</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gastric cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group receives an Isocaloric diet with low carbohydrate content. Dietary components will change weekly in order to increase MCT oil consumption. The carbohydrates are limited to 10 to 15% of  daily energy intake. Proteins are 20 to 30% of energy, fats are 45 to 55% of daily energy, and remaining energy will be supplied by MCT oil 15 to 30% with a gradually increasing method. Intervention 2: Patients in the control group are recipients of an Isocaloric standard diet with the normal dietary components based on their dietary requirements.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Dadfarma</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.44, Hojjat-dost Alley, Naderi St, Keshavarz Blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8895 5975</telephone>
        <email>adadfar@razi.tums.ac.ir; alireza.da89@gmail.com</email>
        <affiliation>School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeed Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 44, 5th floor, Clinical nutrition department, Hojjat-dost Alley, Naderi St, Keshavarz Blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8895 5975</telephone>
        <email>saeedhmdphd@hotmail.com</email>
        <affiliation>School of Nutritional Sciences and Dietetics,Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>(Inclusion criteria: diagnosis of gastric adenocarcinoma; patients with ECOG performance status of 0 to 4; patients who have not been gastrectomized; blood, liver, and kidney should be functional; patients aged 18 years and older; both genders will be recruited; leucocytes count be over 3000 cell in each mm3 of blood; neutrophil count be over 1500 cubic millimeter of blood; platelets be over 1500 per each cubic millimeter of blood; total bilirubin lower than 3mg/dL; serum creatinine lower than 2mg/dL; serum potassium less than 5 mmol/L). (Exclusion criteria: Patients which live alone during the intervention without others attendance; Diabetes; patients receiving Insulin or other anabolic drugs along with intervention; pyruvate dehydrogenase complex deficiency; and inherited porphyria ; MCT oil consumption until 5 weeks before recruitment in study; Having congestive heart failure; Uncontrolled hypertension. Severe steatorrhea and diarrhea; Gastrointestinal obstruction; Patients which could not resist the intervention for any reason; Frequent incidence of hypoglycemia during first week of intervention).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>c16</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of stomach</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group receives an Isocaloric diet with low carbohydrate content. Dietary components will change weekly in order to increase MCT oil consumption. The carbohydrates are limited to 10 to 15% of  daily energy intake. Proteins are 20 to 30% of energy, fats are 45 to 55% of daily energy, and remaining energy will be supplied by MCT oil 15 to 30% with a gradually increasing method.</i_keyword>
      <i_keyword>Patients in the control group are recipients of an Isocaloric standard diet with the normal dietary components based on their dietary requirements.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Carcinoembryonic antigen (CEA). Timepoint: Before and after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Ca19-9. Timepoint: Before and after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Serum ketone bodies. Timepoint: Before and after intervention. Method of measurement: Spectrophotometer.</prim_outcome>
      <prim_outcome>FBS. Timepoint: Before and after intervention. Method of measurement: Spectrophotometer.</prim_outcome>
      <prim_outcome>Body Mass Index (BMI). Timepoint: Before and after intervention. Method of measurement: Formula.</prim_outcome>
      <prim_outcome>Hs-CRP. Timepoint: Before and after intervention. Method of measurement: Auto analyzer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Insulin. Timepoint: Before and after intervention. Method of measurement: Auto analyzer.</sec_outcome>
      <sec_outcome>Resting energy expenditure (REE). Timepoint: Before and after intervention. Method of measurement: Gathering the produced CO2 by indirect calorimetry.</sec_outcome>
      <sec_outcome>HOMA-IR. Timepoint: Before and after intervention. Method of measurement: Is calculated by the formula.</sec_outcome>
      <sec_outcome>Serum Lactate. Timepoint: Before and after intervention. Method of measurement: Auto analyzer.</sec_outcome>
      <sec_outcome>CBC-diff. Timepoint: Before and after intervention. Method of measurement: Complete blood count and differential.</sec_outcome>
      <sec_outcome>Serum Albumin. Timepoint: Before and after intervention. Method of measurement: Auto analyzer.</sec_outcome>
      <sec_outcome>Karnofsky score. Timepoint: Before and after intervention. Method of measurement: Observation.</sec_outcome>
      <sec_outcome>Eastern Cooperative Oncology Group (ECOG). Timepoint: Before and after intervention. Method of measurement: Observation.</sec_outcome>
      <sec_outcome>Bioelectric Impedance Analysis (BIA). Timepoint: Before and after intervention. Method of measurement: Weight.</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>Vice chancellor of research, International Campus, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-25</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Room 605, 6th floor, Central building of Tehran University of Medical Sciences, Quds St, Keshavarz Blvd. Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
