<?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>IRCT2013073114237N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-09-05</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of soy flour enriched bread on cardiovascular diseases</public_title>
      <acronym></acronym>
      <scientific_title>Effect of soy flour enriched bread consumption or regular weight loss diet on anthropometric indices, blood pressure and  serum  lipid profile and its association with apoE genotype in over weight/ obese women: a randomized controlled trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-09-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13875</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: Soy bread group: energy requirement will be calculated according to equations suggested by the Institute of Medicine, Food and Nutrition Board. for weight loss 300-500 calorie of calculated energy will be reduced . person in this intervention were asked to replace 120gr  of soy bread with usual  bread intake or other cereal. macronutrient composition for all participants will be 50-60% as carbohydrate, 15-20% as protein and &lt;30% as fat. Intervention 2: Usual diet:  energy requirement for each participant will calculated based on equations suggested by the Institute of Medicine, Food and Nutrition Board. 300-500 calorie will reduced for weight loss. subject in this diet will asked to continue their usual bread intake and other cereal products and not to consume soy product. macronutrient composition in this group is similar to the soy bread group.</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>Elham Sharifi Zahabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, Hezar Jerib Avenue</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 1792 2752</telephone>
        <email>Elham_sharifi@nutr.mui.ac.ir</email>
        <affiliation>Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medica</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Sharifi Zahabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, Hezar Jerib Avenue</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 1792 2752</telephone>
        <email>Elham_sharifi@nutr.mui.ac.ir</email>
        <affiliation>Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medica</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria were; female at age range of 19-35 years old; body mass index (BMI) between 25 and 35; no history of any chronic or acute diseases including; diabetes, CVD, hepatic diseases, renal diseases, cancer; not adherence to a specific diet or other medically prescribed diet no lactation and no pregnancy; no consumption of drugs and dietary supplements. Exclusion criteria: not adherence to the study protocol; use of specific drugs or supplementation; smoking; incidence of chronic diseases such as cardiovascular diseases and allergy to soya.</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Soy bread group: energy requirement will be calculated according to equations suggested by the Institute of Medicine, Food and Nutrition Board. for weight loss 300-500 calorie of calculated energy will be reduced . person in this intervention were asked to replace 120gr  of soy bread with usual  bread intake or other cereal. macronutrient composition for all participants will be 50-60% as carbohydrate, 15-20% as protein and &lt;30% as fat.</i_keyword>
      <i_keyword>Usual diet:  energy requirement for each participant will calculated based on equations suggested by the Institute of Medicine, Food and Nutrition Board. 300-500 calorie will reduced for weight loss. subject in this diet will asked to continue their usual bread intake and other cereal products and not to consume soy product. macronutrient composition in this group is similar to the soy bread group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>High Density Lipoprotein. Timepoint: Week2, Week8, Week11, Week17. Method of measurement: mg/dl, Direct enzymatic method.</prim_outcome>
      <prim_outcome>Low Density Lipoprotein. Timepoint: Week2, Week8, Week11, Week17. Method of measurement: mg/dl, Friedewald equation.</prim_outcome>
      <prim_outcome>Serum total choolestrol levels. Timepoint: Week2, Week8, Week11, Week17. Method of measurement: mg/dl, Enzymatic method.</prim_outcome>
      <prim_outcome>Serum triglyceride levels. Timepoint: Week2, Week8, Week11, Week17. Method of measurement: mg/dl, Enzymatic method.</prim_outcome>
      <prim_outcome>ApoE genotype. Timepoint: Week2. Method of measurement: PCR method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: baseline, Week2, Week8, Week11, Week17. Method of measurement: Kilogram, Scale.</sec_outcome>
      <sec_outcome>Body Mass Index. Timepoint: Baseline, Week2, Week8, Week11, Week17. Method of measurement: kg/m2, Weight/Height square.</sec_outcome>
      <sec_outcome>Waist circumference. Timepoint: Week 2, Week 8, Week 11,Week17. Method of measurement: meter, centimeter.</sec_outcome>
      <sec_outcome>Hip circumference. Timepoint: Week 2, Week 8, Week 11, Week 17. Method of measurement: meter, centimeter.</sec_outcome>
      <sec_outcome>Body composition. Timepoint: Week2, Week8, Week11, Week17. Method of measurement: Body Analyser systeme.</sec_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: Week 2, Week 8, Week 11, Week 17. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: Week 2, Week 8, Week 11, Week 17. Method of measurement: Sphygmomanometer.</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, Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-11-14</approval_date>
        <contact_name>Ethical Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezar Jerib Avenue Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
