<?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>IRCT2016121925267N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-26</date_registration>
      <primary_sponsor>Vice chancellor for Research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the efficacy of two types of low-carbohydrate diets on weight, metabolic and inflammatory factors in patients with metabolic syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the efficacy of low-carbohydrate (Paleo diet) and moderate-carbohydrate diet with two delivery mode; “fixed diet plan” vs “calorie counting” on body composition, serum levels of some hepatokines and adipocytokines and flowcytometric analysis of endothelial micro particles (EMPs) in adults with metabolic syndrome: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21157</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Other design features: Balanced Block Randomization.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Metabolic Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 4: Receiving moderate carbohydrate diet with “fixed diet plan” for 12 weeks.&#13;
Medium-carbohydrate diet is defined as a 40% carbohydrate, 30% protein and 30% fat diet. Intervention 2: Intervention group 3: Receiving moderate carbohydrate diet with calorie counting for 12 weeks.&#13;
Medium-carbohydrate diet is defined as a 40% carbohydrate, 30% protein and 30% fat diet. Intervention 3: Intervention group 1: Receiving paleo diet with calorie counting for 12 weeks.&#13;
Low-carbohydrate paleo diet is defined as a 20% carbohydrate, 35% protein and 45% fat diet. Intervention 4: Intervention group 2: Receiving paleo diet with “fixed diet plan” for 12 weeks.&#13;
Low-carbohydrate paleo diet is defined as a 20% carbohydrate, 35% protein and 45% fat diet.</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>Dr.Maryam Mahmoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 44, Hojatdoost Alley, Naderi St, Keshavarz blv, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8895 5569</telephone>
        <email>m-mahmoudi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Maryam Mahmoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 44, Hojatdoost Alley, Naderi St, Keshavarz blv, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8895 5569</telephone>
        <email>m-mahmoudi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria consists of: Age between 20 and 50 years old; Diagnosis of metabolic syndrome according to the NCEP-ATPIII criteria (If three or more of the following five criteria are met: Waist circumference over 40 inches (men) or 35 inches (women); Blood pressure over 130/85 mmHg; Fasting triglyceride (TG) level over 150 mg/dl; Fasting high-density lipoprotein (HDL) cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women) and fasting blood sugar over 100 mg/dl). Exclusion criteria are: Alcohol and tobacco consumption; Pregnancy; Lactation;  Menopause; History of acute or chronic liver failure; Acute or chronic gastrointestinal diseases, Cholestasis; Diabetes, Kidney disease, Seizure, Autoimmune diseases, Thyroid disorders; Using hormonal drugs such as estrogen, Hormone replacement therapy, Routine consumption of oral contraceptives, Insulin therapy; Malignancy or neoplasia; Routine consumption of antioxidants and vitamin/mineral supplements; Following vegetarian diet or any other special diet in the last 3 months.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</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>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 4: Receiving moderate carbohydrate diet with “fixed diet plan” for 12 weeks.&#13;
Medium-carbohydrate diet is defined as a 40% carbohydrate, 30% protein and 30% fat diet.</i_keyword>
      <i_keyword>Intervention group 3: Receiving moderate carbohydrate diet with calorie counting for 12 weeks.&#13;
Medium-carbohydrate diet is defined as a 40% carbohydrate, 30% protein and 30% fat diet.</i_keyword>
      <i_keyword>Intervention group 1: Receiving paleo diet with calorie counting for 12 weeks.&#13;
Low-carbohydrate paleo diet is defined as a 20% carbohydrate, 35% protein and 45% fat diet.</i_keyword>
      <i_keyword>Intervention group 2: Receiving paleo diet with “fixed diet plan” for 12 weeks.&#13;
Low-carbohydrate paleo diet is defined as a 20% carbohydrate, 35% protein and 45% fat diet.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Scale.</prim_outcome>
      <prim_outcome>Body Composition. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Body Impedence Analysis.</prim_outcome>
      <prim_outcome>Serum Asprosin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.</prim_outcome>
      <prim_outcome>Serum Chemerin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.</prim_outcome>
      <prim_outcome>FGF-21. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.</prim_outcome>
      <prim_outcome>Serum CTRP1. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.</prim_outcome>
      <prim_outcome>Plasma level of Endothelial Microparticles (CD 31,105, 146). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Flowcytometry.</prim_outcome>
      <prim_outcome>Appetite regulatory hormones (Peptide YY and ghrelin). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lipid profiles (TC, TG, LDL-C, HDL-C). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Enzymatic methods for TC,TG and HDL-C For LDL-C : Freidwald’s formula: LDL-C = TC- HDL-C - (TG/5).</sec_outcome>
      <sec_outcome>Fasting blood glucose. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Enzymatic colorimetric.</sec_outcome>
      <sec_outcome>Fasting insulin serum. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.</sec_outcome>
      <sec_outcome>Insulin resistance. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: HOMA-IR calculation.</sec_outcome>
      <sec_outcome>Insulin sensitivity. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: QUICKI calculation.</sec_outcome>
      <sec_outcome>Urine Sodium. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Electrolyte Analyzer.</sec_outcome>
      <sec_outcome>Urine Potassium. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Electrolyte Analyzer.</sec_outcome>
      <sec_outcome>HS-CRP. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.</sec_outcome>
      <sec_outcome>Appetite changes. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: VAS questionnaire.</sec_outcome>
      <sec_outcome>Leptin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.</sec_outcome>
      <sec_outcome>Creatinine. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Spectrophotometer.</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 for Research, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-04-08</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Qods St, Keshavarz blv, Tehran, Iran. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
