<?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>IRCT201312073733N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-01-03</date_registration>
      <primary_sponsor>Isfahan Cardiovascular Research Institute</primary_sponsor>
      <public_title>Investigation the effect of hull-less barley bread on lipid profile, fasting blood sugar and effective factors on vascular endothelial function in hypercholestrolemic patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigation the effect of hull-less barley bread on lipid profile, fasting blood sugar and effective factors on vascular endothelial function in hypercholestrolemic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3844</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypercholesterolemic.</hc_freetext>
      <i_freetext>Intervention 1: All subjects were provided with a hypo caloric diet in the calorie range of 1500- 2000 for 4 weeks. the intervention group received the hypocaloric diet containing an experimental bread rich in beta-glucan from oat bran (at least five servings (150 g) per day based on their needs, each serving of which had 6 gram beta-glucan). Their adherence to diet was checked weekly by a dietitian through a diary log in which the daily amounts of all consumed foods including bread were recorded. They were asked to continue their routine levels of physical activity and not to consume fiber supplements, weight loss drugs, herbals medicines, or laxatives. During the course of the intervention, the participants attended weekly visits with the mentioned resident and nutritionist (who evaluated their daily intake of food items. Intervention 2: All subjects were provided with a hypo caloric diet in the calorie range of 1500- 2000 for 4 weeks. The control group consumed the hypocaloric diet with control bread rich in wheat fiber (at least five servings (150 g) per day based on their needs, with no beta-glucan). Their adherence to diet was checked weekly by a dietitian through a diary log in which the daily amounts of all consumed foods including bread were recorded. They were asked to continue their routine levels of physical activity and not to consume fiber supplements, weight loss drugs, herbals medicines, or laxatives. During the course of the intervention, the participants attended weekly visits with the mentioned resident and nutritionist (who evaluated their daily intake of food items.</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 Hamidreza Roohafza</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan Cardiovascular Research Institute,Sedighe Tahereh Research Center, khorram Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1335 9090</telephone>
        <email>hroohafza@gmail.com</email>
        <affiliation>Isfahan Cardiovascular Research Institute</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Masoumeh Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan Cardiovascular Research Institute, Sedigheh Tahereh Research Center, khorram Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1335 9090</telephone>
        <email>sadeghimasoumeh@gmail.com</email>
        <affiliation>Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Age 25-65 years old; hypercholesterolemia patients who receiving statins for hypercholesterolemia. &#13;
 Exclusion criteria: Diabetes type one or two; hypothyroidism; renal failure; anemia; cholestasis; pancreatic cancer or malignancy; secondary dyslipidemia; used antihypertensive drugs; alcohol; smoked; did regular exercise; had a history of eating disorder; had weight changes (losing or gaining more than three kilogram weight during the three months prior to the study)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E78.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low-density-lipoprotein-type [LDL] hyperlipoproteinaemia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>All subjects were provided with a hypo caloric diet in the calorie range of 1500- 2000 for 4 weeks. the intervention group received the hypocaloric diet containing an experimental bread rich in beta-glucan from oat bran (at least five servings (150 g) per day based on their needs, each serving of which had 6 gram beta-glucan). Their adherence to diet was checked weekly by a dietitian through a diary log in which the daily amounts of all consumed foods including bread were recorded. They were asked to continue their routine levels of physical activity and not to consume fiber supplements, weight loss drugs, herbals medicines, or laxatives. During the course of the intervention, the participants attended weekly visits with the mentioned resident and nutritionist (who evaluated their daily intake of food items.</i_keyword>
      <i_keyword>All subjects were provided with a hypo caloric diet in the calorie range of 1500- 2000 for 4 weeks. The control group consumed the hypocaloric diet with control bread rich in wheat fiber (at least five servings (150 g) per day based on their needs, with no beta-glucan). Their adherence to diet was checked weekly by a dietitian through a diary log in which the daily amounts of all consumed foods including bread were recorded. They were asked to continue their routine levels of physical activity and not to consume fiber supplements, weight loss drugs, herbals medicines, or laxatives. During the course of the intervention, the participants attended weekly visits with the mentioned resident and nutritionist (who evaluated their daily intake of food items.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lipid Profile. Timepoint: Before and after intervention. Method of measurement: Autoanalyzer.</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: Before and after intervention. Method of measurement: Autoanalyzer.</prim_outcome>
      <prim_outcome>Flow-mediated dilation (FMD). Timepoint: Before and after intervention. Method of measurement: FMD is a noninvasive technique where forearm ischemia is induced by inflating a sphygmomanometer cuff to 50-100 mmHg for five minutes.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body mass index. Timepoint: before and after intervention. Method of measurement: Body mass index (BMI) was calculated as weight divided by height squared.</sec_outcome>
      <sec_outcome>Hip circumference. Timepoint: before and after intervention. Method of measurement: measured based on standard protocols.</sec_outcome>
      <sec_outcome>Waist circumference. Timepoint: before and after intervention. Method of measurement: measured based on standard protocols.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: before and after intervention. Method of measurement: after 20-minuterest, in sitting position.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Isfahan University of Medical Sciences</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 Cardiovascular Research Institute</source_name>
      <source_name>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-10-27</approval_date>
        <contact_name>Isfahan Cardiovascular Research Institute Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan Cardiovascular Research Institute, Khorram, Ave Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
