<?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>IRCT201205079662N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-06-10</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effects of natural and commercial orange juice consumption in inflammatory factors ( hs-CRP; ICAM; VCAM; IL-6; E-Selectin )and endothelial function evaluation (FMD ) in healthy volunteers</public_title>
      <acronym></acronym>
      <scientific_title>Effects of natural and commercial orange juice consumption in blood pressure and inflammatory factors in healthy volunteers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10223</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Blood pressure. Condition 2: flow-mediated dilatation (FMD).</hc_freetext>
      <i_freetext>Intervention 1: 500 ml of  fresh orange juice consumption in group 1 for 4wk. Intervention 2: 500 ml of Commercial  orange juice consumption in group 1, for 4wk.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>http://www.ncbi.nlm.nih.gov/pubmed/23696766</results_url_link>
      <results_summary>           Abstract &lt;br /&gt;&#13;
BACKGROUND:  Citrus  sinensis  juice  (CSJ)  is  a  rich  source  of  dietary flavonoids  which  reduce &lt;br /&gt;&#13;
the risk of adverse cardiovascular events. This study aimed to examine the effects of four-week &lt;br /&gt;&#13;
intake  of  natural  and  commercial  orange  (Citrus  sinensis)  juice  on  blood  pressure  in  healthy &lt;br /&gt;&#13;
volunteers. &lt;br /&gt;&#13;
METHODS:  In  this  single-blind  randomized  crossover  study,  22  healthy  subjects  (age:  18-59 &lt;br /&gt;&#13;
years  old)  were  included  and  randomly  divided  into  two  groups  of  11.  Group  A  consumed &lt;br /&gt;&#13;
commercial  CSJ  during  the  first  four-week  period.  After  a  two-week  washout  period,  they &lt;br /&gt;&#13;
consumed  natural  CSJ  for  another  four  weeks.  The  procedure  was  reversed  in  group  B.  The &lt;br /&gt;&#13;
participants were asked to drink 500 ml/day of either natural or commercial  CSJ twice a day &lt;br /&gt;&#13;
with breakfast and dinner. The effects of orange juice on blood pressure were evaluated. &lt;br /&gt;&#13;
RESULTS:  After  drinking  commercial  CSJ,  diastolic  and  systolic  blood  pressure  were &lt;br /&gt;&#13;
significantly  decreased  (5.13%;  P  =  0.03  and  -5.91%;  P  =  0.003,  respectively).  However, &lt;br /&gt;&#13;
consumption of natural CSJ did not have significant effects on either diastolic or systolic blood &lt;br /&gt;&#13;
pressure. &lt;br /&gt;&#13;
CONCLUSION: Commercial  CSJ  significantly  decreased  blood  pressure.  Higher  flavonoid, &lt;br /&gt;&#13;
pectin, and essential oils content of concentrated products compared to natural juice might have &lt;br /&gt;&#13;
been responsible for this finding. Nevertheless, further studies to focus on dose-response effects &lt;br /&gt;&#13;
are recommended. &lt;br /&gt;&#13;
Keywords:Citrus sinensis Juice, Hypertension, Blood Pressure </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></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sedigheh Asgary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorram Street,  Jomhoori Square</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31133595959</telephone>
        <email>sasgary@yahoo.com</email>
        <affiliation>Isfahan Cardiovascular Research Center, Applied Physiology Research Center,  Isfahan University of M</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Healthy individuals 19-59 years.&#13;
Exclusion criteria: Individuals with a history of diseases; diabetes; cardiovascular disease; liver and kidney as well as those with thyroid disease; pregnant and breastfeeding; individuals with dyslipidemia, metabolic and endocrine diseases and those with a vegetarian diet.</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>59 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10-I15</hc_code>
      <hc_code>I70-I79</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypertensive diseases</hc_keyword>
      <hc_keyword>Diseases of arteries, arterioles and capillaries</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>500 ml of  fresh orange juice consumption in group 1 for 4wk</i_keyword>
      <i_keyword>500 ml of Commercial  orange juice consumption in group 1, for 4wk.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Positive changes in inflammatory markers. Timepoint: Baseline and   after 4 weeks. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Positive changes in endothelial function. Timepoint: Baseline and after 4 weeks. Method of measurement: Doppler ultrasonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Decrease in blood pressure. Timepoint: Baseline and after 4 weeks. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>Positive changes in lipid profiles. Timepoint: Baseline and after 4 weeks. Method of measurement: kit.</sec_outcome>
      <sec_outcome>Cholesterol Level. Timepoint: Before and after 4 weeks. Method of measurement: KIT.</sec_outcome>
      <sec_outcome>HDL Level. Timepoint: Before and after 4 weeks. Method of measurement: KIT.</sec_outcome>
      <sec_outcome>LDL level. Timepoint: Before and after 4 weeks. Method of measurement: KIT.</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 Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar jirib st. Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
