<?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>IRCT20220105053631N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-29</date_registration>
      <primary_sponsor>Islamic Azad The university of Research Sciences Branch</primary_sponsor>
      <public_title>The effect of aerobic exercise with different intensities and spirulina supplementation on ACE2 expression</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of high and moderate intensity aerobic exercise with spirulina supplementation on ACE2 receptor sensitivity in obese people during SARS-COVID-2 epidemic</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61202</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Prevention, Other design features: This study is designed based on the researcher's idea and its molecular cell pathway is invented by the researcher. Increased exercise-induced irisin increases the expression of the TRIB3 gene, and increased expression of this gene causes changes in the expression of ACE2 (the main receptor of Covid 19). Therefore, reducing the expression of ACE2 as the main receptor of Covid 19 can be effective in preventing Covid 19, especially in obese people. Because obese people naturally have an increase in ACE2 expression, Randomization description: The sampling method in this study will be randomly classified. The number of samples is 72 (36 men and 36 women). Since the expression of the effect of Intervenors may be significantly different according to the sex of individuals, so in sampling we study an equal number of each sex. Also, considering that the age range of the samples in the study is between 40 and 50 years, in order to be able to make comparisons in age ranges, the categories include people aged 40 to 43 years, 44 to 47 years and 48 to 50 years in We do both groups of men and women. Based on this, we divide the sample space into 6 blocks of 12 people. Since in this study, one category belongs to the control group and five categories belong to the intervention group, so each block includes 2 members from each of these categories, which is placed in that category based on gender and age. The sealed envelop online software at https://www.sealedenvelope.com is used to randomize the sampling, Blinding description: In order to eliminate the error caused by the knowledge of the participants and the researcher about the type of 
treatment received and its possible effect on the research result, the study was conducted in two ways.
We do blind. The placebo and the spirulina supplement are placed inside the capsule in exactly the same way, which is no different, so the participants and the researcher are not aware of the type of supplement received.</study_design>
      <phase>3</phase>
      <hc_freetext>obesity.</hc_freetext>
      <i_freetext>Intervention group: Intervention group 1: high intensity aerobic exercise; Second intervention group: moderate intensity aerobic exercise; Third intervention group; Spirulina supplementation; Fourth intervention group; High-intensity aerobic exercise with spirulina supplementation; Fifth intervention group; Moderate-intensity aerobic exercise with spirulina supplementation; Sixth intervention group; control 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>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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fariba Armannia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Above Keshavarz Boulevard, Kabkanian Alley, Qazvini Alley, No. 9, Unit 8</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1415733868</zip>
        <telephone>+98 21 8145 4502</telephone>
        <email>phd.armannia@gmail.com</email>
        <affiliation>The  university of Islamic Azad University, Research Sciences Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Armannia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Above Keshavarz Boulevard, Kabkanian Alley, Qazvini Alley, No. 9 Unit</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1415733868</zip>
        <telephone>0098 21 814502</telephone>
        <email>phd.armannia@gmail.com</email>
        <affiliation>The univercity of Islamic Azad University of Research Sciences, Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy obese people 40 to 50 years without mobility restrictions</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any type of disease including cardiovascular, diabetes, hypertension, thyroid and in general any type of acute and chronic diseases
Movement restrictions</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>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group 1: high intensity aerobic exercise; Second intervention group: moderate intensity aerobic exercise; Third intervention group; Spirulina supplementation; Fourth intervention group; High-intensity aerobic exercise with spirulina supplementation; Fifth intervention group; Moderate-intensity aerobic exercise with spirulina supplementation; Sixth intervention group; control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Angiotensin converting enzyme 2 expression level. Timepoint: At the beginning of the study; And 8 weeks after starting spirulina supplementation and aerobic exercise. Method of measurement: reverse transcription–polymerase chain reaction.</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>Islamic Azad The university of Research Sciences Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-10</approval_date>
        <contact_name>Islamic Azad University, North Tehran Branch</contact_name>
        <contact_address>Vafadar Blvd., Shahid Sadoughi St., Hakimiyeh Exit, Shahid Babaee Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
