<?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>IRCT20200417047105N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-19</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Traditional Persian medicine based hot and cold foods and Metabolic Responses and Arterial Stiffness</public_title>
      <acronym>HCFMR</acronym>
      <scientific_title>Evaluation of the acute  effect of Traditional Persian medicine based hot and cold foods on Metabolic Responses and Arterial Stiffness in healthy men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47267</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Basic scienece.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Men with Traditional Persian Medicine  based hot and cold temperaments.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: men with hot temperament that will receive two test meals in 2 days including Traditional based medicine hot and cold food. they will evaluate during 4hours. Intervention 2: Intervention group: Intervention group: men with cold temperament that will receive two test meals in 2 days including Traditional based medicine hot and cold food. they will evaluate during 4hours.</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:
The non-identifiable individual participant data collected in this study will be shared. Also, The protocol, results, and statistical analysis of the current study will be published in the relevant articles.

When:
The non-identifiable individual participant data will become available after the publication of the relevant articles.

To whom:
they will be available for people working in academic institutions and people working in businesses can also apply to receive it.

Conditions:
The non-identifiable individual participant data can only be used for research.

Where to obtain:
The non-identifiable individual participant data will be obtainable by sending an e-mail to Mohsen Zakerian (Zakerianmohsen@gmail.com)

How to obtain:
Other researchers in academic institutions can send their request by e-mail to Mohsen Zakarian. The data will be sent to them after consulting and approving the research team.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Zakerian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad University of Medical Sciences (MUMS) Campus of University (Paradise Daneshgah), Azadi Square</address>
        <city>mashahd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91779-48564</zip>
        <telephone>+98 51 3800 2423</telephone>
        <email>zakerianmohsen@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Zakerian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad University of Medical Sciences (MUMS) Campus of University (Paradise Daneshgah), Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91779-48564</zip>
        <telephone>+98513002423</telephone>
        <email>zakerianmohsen@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>a BMI of 18.5-25 kg/m2, body fat percent between 12-22%, waist circumference &lt;90cm
aged 20-25 years
Men
Signing the Written informed consent
willing to undertake required fasting durations</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>25 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Use of supplement for weight loss and weight gain
Professional athlete
who cannot consume test meals due to intolerances/dietary preferences (i.e. vegan, gluten, milk proteins)
change in body weight greater than 10% in 6 months past
Current smoking
use of medications that might affect study outcomes such as hypo and hyper thyroid and caffein
history of cardiovascular events (acute myocardial infarction, stroke, etc.), hypertension, diabetes mellitus, dyslipidaemia, pharmacological treatment for any of these conditions, neurological and/or neuropsychological disease or the consumption of toxic substances</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E88.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Metabolic disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: men with hot temperament that will receive two test meals in 2 days including Traditional based medicine hot and cold food. they will evaluate during 4hours</i_keyword>
      <i_keyword>Intervention group: Intervention group: men with cold temperament that will receive two test meals in 2 days including Traditional based medicine hot and cold food. they will evaluate during 4hours</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Respiratory quotient. Timepoint: during 4 hours after test meal(half hours after meal and thus every 2 hours until 4 hours). Method of measurement: Indirect calorimetry.</prim_outcome>
      <prim_outcome>Resting energy expenditure. Timepoint: during 4 hours after test meal(half hours after meal and thus every 2 hours until 4 hours). Method of measurement: Indirect calorimetry.</prim_outcome>
      <prim_outcome>Total energy expenditure. Timepoint: during 4 hours after test meal(half hours after meal and thus every 2 hours until 4 hours). Method of measurement: Indirect calorimetry.</prim_outcome>
      <prim_outcome>Diet induced thermogenesis. Timepoint: during 4 hours after test meal(half hours after meal and thus every 2 hours until 4 hours). Method of measurement: Indirect calorimetry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pulse wave analysis. Timepoint: during 4 hours after test meal(half hours after meal and thus every 2hours until 4 hours). Method of measurement: Tonometry.</sec_outcome>
      <sec_outcome>Pulse wave velocity. Timepoint: during 4 hours after test meal(half hours after meal and thus every 2hours until 4 hours). Method of measurement: Tonometry.</sec_outcome>
      <sec_outcome>Blood sugar. Timepoint: during 4 hours after test meal(half hours after meal and thus every 2hours until 4 hours). Method of measurement: blood sample.</sec_outcome>
      <sec_outcome>Insulin. Timepoint: during 4 hours after test meal(half hours after meal and thus every 2hours until 4 hours). Method of measurement: blood sample.</sec_outcome>
      <sec_outcome>Lipid profile. Timepoint: during 4 hours after test meal(half hours after meal and thus every 2hours until 4 hours). Method of measurement: blood sample.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-04-13</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Campus of University (Paradise Daneshgah), Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
