<?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>IRCT2014090719072N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-02-11</date_registration>
      <primary_sponsor>Isfahan  University of  Medica Science ,Deputy Director of Research and Development</primary_sponsor>
      <public_title>The Effect of Dietary Approach to Stop Hypertension (DASH) on Insulin Resistance</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of  DASH (Dietary Approach to Stop Hypertension) on IRS1 and  PPARҮ2 Genes Expression in Obese Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-03-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17147</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece.</study_design>
      <phase>N/A</phase>
      <hc_freetext>healthy  obese volunteer.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group will prescribe DASH diet that is rich in fruits, vegetables, whole grains, and low fat dairy products,  and low in saturated fat, total fat, cholesterol, refined grains and sweets .The diets would be prescribed weekly, and an exchange list would be given to each patient for exchanging food items and counting the calories. A nutritionist will teach subjects how to apply the exchange list and write food diaries. Every participant will bring her 3-day diet records every month, and the dairies would be reviewed by N4 nutritional software and their compliance would be assessed by analyzing the three food record diaries monthly and the attendance at meetings and monthly visits. Intervention 2: The control group was recommended to “eat as usual” and received  healthy dietary advises which would be printed on a paper .Every participant will bring his 3-day diet records every month, and the dairies would be reviewed by NUTRITIONIST 4 software and their diet was assessed by analyzing the three food record diaries.</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 Mohammad Hasan  Entezari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>iNutrition School, Isfahan  University of Medical Science,  Hezarjerib Street, Azadi Squre, Isfahan.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 2776</telephone>
        <email>entezari@hlth.mui.ac.ir</email>
        <affiliation>Isfahan  University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mohammad hasan Entezari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition School, Isfahan  University of Medical Science,  Hezarjerib Street, Azadi Squre, Isfahan.</address>
        <city>ISFAHAN</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 2767</telephone>
        <email>entezari@hlth.mui.ac.ir</email>
        <affiliation>Isfahan  University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: female; Body Mass Index above 30; age 20-50; absence of cardiovascular; hepatic; renal; thyroid; diabetes; rheumatoid arthritis; lupus; severe infection; trauma; allergy disease; don't use of multivitamin and mineral or omega-3 fatty acids supplements; don't regular use of antacid drugs containing magnesium and calcium ; consumption Aspirin and Non Steroid Anti Inflammation; and anti-depressant and hormone drugs; lack of pregnancy and breastfeeding; don't get weight loss in 6 months (more than 1 kg; don't use of tobacco and alcohol.&#13;
 Exclusion criteria: Failure to follow the prescribed diet( energy intake is different more than 300 calorie from prescribed as regard to food record analysis&#13;
), if  weight change is more than 5%, diagnosis one of mentioned disease in inclusion criteria and using of chemical or herbal medicines during the study.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Simple obesity NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group will prescribe DASH diet that is rich in fruits, vegetables, whole grains, and low fat dairy products,  and low in saturated fat, total fat, cholesterol, refined grains and sweets .The diets would be prescribed weekly, and an exchange list would be given to each patient for exchanging food items and counting the calories. A nutritionist will teach subjects how to apply the exchange list and write food diaries. Every participant will bring her 3-day diet records every month, and the dairies would be reviewed by N4 nutritional software and their compliance would be assessed by analyzing the three food record diaries monthly and the attendance at meetings and monthly visits.</i_keyword>
      <i_keyword>The control group was recommended to “eat as usual” and received  healthy dietary advises which would be printed on a paper .Every participant will bring his 3-day diet records every month, and the dairies would be reviewed by NUTRITIONIST 4 software and their diet was assessed by analyzing the three food record diaries.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>PPAR gamma Gene Expression. Timepoint: Before Intervention and After 3 Months. Method of measurement: Real Time Polymerase Chain Reaction.</prim_outcome>
      <prim_outcome>IRS1  Gene Expression. Timepoint: Before Intervention and After 3 Months. Method of measurement: Real Time Polymerase Chain Reaction.</prim_outcome>
      <prim_outcome>Insulin resistance. Timepoint: Before Intervention and After 3 Months. Method of measurement: Hemostatic Model Assessment(HOMA).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: Before Study and After 3 Months. Method of measurement: Scale.</sec_outcome>
      <sec_outcome>Fasting Sugar. Timepoint: Before Study and After 3 Months. Method of measurement: Caloremetric.</sec_outcome>
      <sec_outcome>Fasting  Insulin. Timepoint: Before Study and  After 3 Month. Method of measurement: Elisa Method.</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>Isfahan  University of  Medica Science ,Deputy Director of Research and Development</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-07-06</approval_date>
        <contact_name>Isfahan University OF Medical Science</contact_name>
        <contact_address>Nutrition School, Isfahan  University of Medical Science,  Hezarjerib Street, Azadi Squre, Isfahan. Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
