<?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>IRCT20170506033836N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-15</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effects of functional cake</public_title>
      <acronym></acronym>
      <scientific_title>The effects of functional cake in patients with metabolic syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48320</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization  between the two groups will be done by block randomization. In this way, the size of the blocks is considered 4 and all possible scenarios are written for two groups A and B and this process is repeated until the number reaches 80 people. Then a number is given to each of the block components using a random number table. The numbers given to each of the block components represent the number assigned to each person in advance. This identifies the group assigned to each individual, Blinding description: Participants, Investigators, and associated research and laboratory personnel will remain blinded to patient allocation until after study completion.The designed placebo is completely similar to the intervention group in terms of color, size and model. For blinding the packs of cakes is coded in A and B sounds by the third party  who is not involved in the research process.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Metabolic Syndrome. Condition 2: Obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Functional cake group containing oak powder.The caloric content of both oak and wheat cakes will be equal, so due to the higher calorie content of oak flour, 10 grams of oak flour is sweetened in the preparation of cakes containing oak flour and about 13.8 grams of wheat flour will be used in the preparation of cakes containing wheat flour.In this way, a cake with a weight of approximately 30 grams will be produced and standardized packaging. Intervention 2: Control group: Ordinary cake group containing wheat powder.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Laboratory data file can be published

When:
After the intervention

To whom:
For researchers and industry professionals

Conditions:
The use of data is allowed in the industry

Where to obtain:
Mohsen Mohammadi Sartang
mohamadism@sums.ac.ir

How to obtain:
The possibility of requesting is checked via email and will be answered within a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Mohamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khalili street</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>11111111</zip>
        <telephone>+98 71 3612 2206</telephone>
        <email>mohsen.nut@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Mohamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khalili street</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1111111</zip>
        <telephone>+98 71 3612 2206</telephone>
        <email>mohamadism@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 20 to 60 years
Body mass index (BMI) of 25–35 kg/m2
According to the ATP III definition, metabolic syndrome is present if three or more of the following five criteria are met: waist circumference over 102 cm (men) or 88 cm (women), blood pressure over 130/85 mmHg, fasting triglyceride (TG) level over 150 mg/dl, fasting high-density lipoprotein (HDL) cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women) and fasting blood sugar over 100 mg/dl
Stable body weight (weight change less than 3 kg in the last 3 months)
Not participating in weight loss programs for the past 6 months</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diabetic patients receiving blood sugar-lowering drugs and insulin
History of alcohol consumption
Smoking
Pregnant and lactating women
People with mental illness, cancer, thyroid, cardiovascular, pulmonary, renal, hepatic, eating disorders
Taking drugs that affect appetite, body weight and lipid metabolism or have anti-inflammatory effect</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E88.81</hc_code>
      <hc_code>E66.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Metabolic syndrome</hc_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: Functional cake group containing oak powder.The caloric content of both oak and wheat cakes will be equal, so due to the higher calorie content of oak flour, 10 grams of oak flour is sweetened in the preparation of cakes containing oak flour and about 13.8 grams of wheat flour will be used in the preparation of cakes containing wheat flour.In this way, a cake with a weight of approximately 30 grams will be produced and standardized packaging</i_keyword>
      <i_keyword>Control group: Ordinary cake group containing wheat powder</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anthropometric measures. Timepoint: Before and after the intervention. Method of measurement: Bioelectric impedance analysis.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Before and after the intervention. Method of measurement: digital sphygmomanometer.</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: Before and after the intervention. Method of measurement: Commercial kits.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: Before and after the intervention. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Insulin resistance index (HOMA-IR). Timepoint: Before and after the intervention. Method of measurement: Formula.</prim_outcome>
      <prim_outcome>Lipids profile. Timepoint: Before and after the intervention. Method of measurement: Commercial kits.</prim_outcome>
      <prim_outcome>Malon de aldehyde (MDA). Timepoint: Before and after the intervention. Method of measurement: Tubarbitoric acid method (TBARS).</prim_outcome>
      <prim_outcome>C-reactive protein. Timepoint: Before and after the intervention. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Adiponectin. Timepoint: Before and after the intervention. Method of measurement: ELISA kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>2020-03-14</approval_date>
        <contact_name>The ethics committee of Baqiyatallah University of Medical Sciences, Tehran, Iran</contact_name>
        <contact_address>Tehran, Vanak Square, Mulla Sadra Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
