<?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>IRCT20190819044563N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-21</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Low-Calorie diet rich in whole grains and legumes on Obese Women with Hedonic Eating Behaviors</public_title>
      <acronym></acronym>
      <scientific_title>The effects of low-calorie diet rich in whole grains and legumes on appetite control, improvement of hedonic eating behavior, lipid and glycemic profile, Serum levels of serotonin and insulin and  hs-CRP in Obese women with hedonic eating behavior</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43551</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using stratified block randomization And according to BMI, people are divided into two groups, Blinding description: The intervention and control groups each go to the clinic on separate days and receive their diet, and the control group, like the intervention group, assumes that the weight loss diet is the same for everyone, but this is the case. That the control and intervention groups did not know each other's diet because they received their diet separately.</study_design>
      <phase>3</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Low-calorie diet (500kg reduction per person daily requirement) plus at least 4 whole grains and 3 legumes per day for three months. Intervention 2: Control group: Low-calorie diet (500kg reduction per person daily requirement) for three months.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Asma Zamanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kosar Dormitory,Urmia University of Medical Sciences,Nazlou, Serow Road</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3223 4897</telephone>
        <email>asma_wzm@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Manafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutrition, Faculty of Medicine, Urmia University of Medical Sciences, Sero Highway, Urmia, Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0098 44 5714783734</zip>
        <telephone>+98 44 3223 4897</telephone>
        <email>majidmanafi@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Individuals with BMI ≥25
Hedonic eating behavior</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Chronic diseases such as diabetes and coronary heart disease
Cancer
smoking
Uncontrolled High Blood Pressure (above 100/160 mmHg)
Pregnancy and lactation
Use of antibiotic drugs for 3 months
Digestive tract diseases
Autoimmune disease
Use of immunosuppressants
Taking medication for dyslipidemia
Use of medications that affect metabolism, blood sugar, appetite and food intake
Taking non-steroidal anti-inflammatory drugs
Observe a specific diet
Take a diet to lose weight</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>Intervention group: Low-calorie diet (500kg reduction per person daily requirement) plus at least 4 whole grains and 3 legumes per day for three months</i_keyword>
      <i_keyword>Control group: Low-calorie diet (500kg reduction per person daily requirement) for three months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Triglyceride. Timepoint: Blood triglyceride levels at baseline (before intervention) and at the end of the study at week 12. Method of measurement: Serum triglyceride concentration measurement by enzymatic method with BT1500.</prim_outcome>
      <prim_outcome>High-density lipoprotein. Timepoint: Blood High-density lipoprotein levels at baseline (before intervention) and at the end of the study at week 12. Method of measurement: Serum high-density lipoprotein concentration measurement by enzymatic method with BT1500.</prim_outcome>
      <prim_outcome>Low-density lipoprotein. Timepoint: Blood Low-density lipoprotein levels at baseline (before intervention) and at the end of the study at week 12. Method of measurement: Serum low-density lipoprotein concentration measurement by enzymatic method with BT1500.</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: Blood Fasting blood sugar levels at baseline (before intervention) and at the end of the study at week 12. Method of measurement: Serum fasting blood sugar concentration measurement by enzymatic method of glucose oxidase with BT1500.</prim_outcome>
      <prim_outcome>Total cholesterol. Timepoint: Blood Total cholesterol levels at baseline (before intervention) and at the end of the study at week 12. Method of measurement: Serum total cholesterol concentration measurement by enzymatic method with BT1500.</prim_outcome>
      <prim_outcome>C-reactive protein. Timepoint: Blood C-reactive protein levels at baseline (before intervention) and at the end of the study at week 12. Method of measurement: Serum total cholesterol concentration measurement by enzymatic method with BT1500.</prim_outcome>
      <prim_outcome>Appetite. Timepoint: In the first weeks, 6 and 12 study and each day for 3 days at noon meal (before eating the main meal and after eating for 3 hours will be filled as 1 hour, 2 hours and 3 hours after meal). Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Hedonic eating behavior. Timepoint: The first week and 12 studies were assessed using a questionnaire. Method of measurement: Using the  Power of Food Scale Questionnaire.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: Blood Insulin levels at baseline (before intervention) and at the end of the study at week 12. Method of measurement: Measurement of serum insulin concentration by immuno-radiometric method with BT1500.</prim_outcome>
      <prim_outcome>Serotonin. Timepoint: Blood Serotonin levels at baseline (before intervention) and at the end of the study at week 12. Method of measurement: Serum  Concentration Determination by ELISA.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: Body mass index measurement in the first week and 12 studies. Method of measurement: Using height and weight values.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: Weight measurement at baseline (before intervention) and at 1, 6 and 12 weeks. Method of measurement: The weight of a person with minimal clothing and no shoes is measured to the nearest with BIA.</sec_outcome>
      <sec_outcome>Physical activity. Timepoint: Physical activity measurement at baseline (before intervention) and at 1, 6 and 12 weeks. Method of measurement: Measurement of physical activity at three levels of light, moderate and vigorous using the International Physical Activity Questionnaire.</sec_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: Systolic blood pressure measurement at baseline (before intervention) and at 1 and 12 weeks. Method of measurement: Using a calibrated digital barometer.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: Diastolic blood pressure measurement at baseline (before intervention) and at 1 and 12 weeks. Method of measurement: Using a calibrated digital barometer.</sec_outcome>
      <sec_outcome>Height. Timepoint: Measurement of individuals height at baseline (before intervention). Method of measurement: Using BIA.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-02</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Department of Nutrition, Faculty of Medicine, Urmia University of Medical Sciences, Sero Highway, Urmia, Iran Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
