<?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>IRCT20180509039596N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-25</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of whey protein and dietary fiber on appetite and weight management</public_title>
      <acronym></acronym>
      <scientific_title>The effect of biscuit fortified with whey protein and dietary fiber on biochemical and behavioral factors of appetite, anthropometric indices, and glycemic profile in overweight or obese adults</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31272</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balanced block randomization method will be used to random allocation, and randomization unit will be a subject. At first, we will design blocks with different sequences of A, B, C, and D. Then we will select a block, in a draw. Each block contain a sequence of A, B, C, and D which determine intervention groups. Participants and researchers will not be notified the packages content, Blinding description: Participants, clinical assessor, and researcher will be blind. Participants, clinical assessor, and researcher don't know subjects allocated to which group. Participants will be identified by A, B, C, and D letters.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Overweight and obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Whey protein and dietary fiber enriched biscuits. Biscuits will be consumed during 60 days of intervention duration. Participants will take 14 grams pre day whey protein. Dietary fiber will be added to biscuits as wheat bran, 15% of wheat flour. Intervention 2: Intervention group: Whey protein enriched biscuits. Biscuits will be consumed during 60 days of intervention duration. Participants will take 14 grams pre day whey protein. Intervention 3: Intervention group: Dietary fiber enriched biscuits. Biscuits will be consumed during 60 days of intervention duration. Dietary fiber will be added to biscuits as wheat bran, 15% of wheat flour. Intervention 4: Control group: Biscuit without whey protein or dietary fibe. Biscuits will be consumed during 60 days of intervention duration.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is The publication plan is still unknown</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Hassanzadeh-Rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition and Food Sciences School, Razi Street</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7153675541</zip>
        <telephone>+98 71 3725 1001</telephone>
        <email>Hassanzadeh_z8@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Shiva Faghih</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition and Food Sciences School, Razi Blvd.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7153675541</zip>
        <telephone>+98 71 3725 1001</telephone>
        <email>Shivafaghih@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male and female gender
Age 20 -50 years old
BMI higher than 25 kg/m2</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Follow weight loss diet during 6 months ago
Psychological disorders related to eating disorders
Use of multivitamin-mineral supplements and herbal medications
Chronic disease and use drugs, which affected the metabolism, body composition and appetite
Food allergy
Pregnancy and lactation
Alcohol and tobacco use</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight and obesity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Whey protein and dietary fiber enriched biscuits. Biscuits will be consumed during 60 days of intervention duration. Participants will take 14 grams pre day whey protein. Dietary fiber will be added to biscuits as wheat bran, 15% of wheat flour.</i_keyword>
      <i_keyword>Intervention group: Whey protein enriched biscuits. Biscuits will be consumed during 60 days of intervention duration. Participants will take 14 grams pre day whey protein.</i_keyword>
      <i_keyword>Intervention group: Dietary fiber enriched biscuits. Biscuits will be consumed during 60 days of intervention duration. Dietary fiber will be added to biscuits as wheat bran, 15% of wheat flour.</i_keyword>
      <i_keyword>Control group: Biscuit without whey protein or dietary fibe. Biscuits will be consumed during 60 days of intervention duration.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Energy intake and appetite. Timepoint: Baseline, 14, 28, 42, and 60 days after intervention. Method of measurement: Food record questionnaire, and appetite assessment questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ghrelin. Timepoint: Baseline  and end of intervention. Method of measurement: Elisa kit.</sec_outcome>
      <sec_outcome>Leptin. Timepoint: Baseline  and end of intervention. Method of measurement: Elisa kit.</sec_outcome>
      <sec_outcome>Serotonin. Timepoint: Baseline  and end of intervention. Method of measurement: Elisa kit.</sec_outcome>
      <sec_outcome>Glucagon-like peptide-1 (GLP-1). Timepoint: Baseline  and end of intervention. Method of measurement: Elisa kit.</sec_outcome>
      <sec_outcome>Fasting blood glucose. Timepoint: Baseline  and end of intervention. Method of measurement: Auto Analyzer Biochemistry.</sec_outcome>
      <sec_outcome>Insulin. Timepoint: Baseline  and end of intervention. Method of measurement: Elisa kit.</sec_outcome>
      <sec_outcome>Blood lipids including total cholesterol, low density lipoprotein, high density lipoprotein, and triglyceride. Timepoint: Baseline  and end of intervention. Method of measurement: Auto Analyzer Biochemistry.</sec_outcome>
      <sec_outcome>Body weight. Timepoint: Baseline  and end of intervention. Method of measurement: weight scale.</sec_outcome>
      <sec_outcome>Waist circumeference. Timepoint: Baseline  and end of intervention. Method of measurement: Strip meter.</sec_outcome>
      <sec_outcome>Waist to height ratio. Timepoint: Baseline  and end of intervention. Method of measurement: Strip meter.</sec_outcome>
      <sec_outcome>Fat mass percentage. Timepoint: Baseline  and end of intervention. Method of measurement: Bioelectrical impedance analysis (BIA).</sec_outcome>
      <sec_outcome>Mood indices. Timepoint: Baseline and end of intervention. Method of measurement: Emotionality Activity Sociability (EAS) questionnaire.</sec_outcome>
      <sec_outcome>Quality of Life. Timepoint: Baseline and end of intervention. Method of measurement: Quality of Life questionnaire.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: Baseline and end of intervention. Method of measurement: Weight scale and strip meter.</sec_outcome>
      <sec_outcome>Fat free mass. Timepoint: Baseline and end of intervention. Method of measurement: Bioelectrical impedance analysis (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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-26</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz University of Medical Sciences, Zand street, Shiraz Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
