<?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>IRCT20231218060454N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-21</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of beetroot extract on physical performance</public_title>
      <acronym></acronym>
      <scientific_title>Production of sports drink powder based on beet extract and investigating its effect on cardio-respiratory fitness and</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>31</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74478</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization into 2 groups A (intervention) and B (control) will be performed by the method of random blocks of four. In this method, using one of the randomization software, blocks of 4 including two A and two B will be produced in random order, and by repeating this process, a string of A and B will be obtained. People will be assigned to one of 2 groups A and B according to the order of entering the study according to the string produced. to hide the randomization, the closed envelope method will be used, Blinding description: Produced bars (with and without beetroot extract) are prepared in the same packaging type; only the producer knows their content. Bars will be randomly allocated between the two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>No applicable.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group consumes the designed functional bars 3 hours before the test. Three hours after eating the bar, people will not do any physical activity. The nutritional bars of the present study without surface coating and topping will be prepared by Zarcom Company (Tehran, Iran). The weight of the resulting bar will be determined depending on the amount of nitrate in the beetroot powder (approximately 1.4 mmol/70 grams). The first step in the process of making the nutritional bar involves mixing the liquid ingredients, which include high fructose corn syrup (or honey) and peanut butter. These components are mixed in a regular mixer. The next step in the process is adding the partially dry ingredients to the liquid mixture and stirring to achieve substantial uniformity. Partial dry ingredients are sesame seeds and salt. The third step of the process in the formation of the nutritional bar is the addition of the main dry ingredients to the mixture of the second step of the process. The main dry ingredients are sugar, wheat or barley grains. These components are mixed to obtain a completely homogeneous mixture that does not require drying to form. Then the mixture is compressed in a container covered with oil paper and allowed to form a mold. Bars are cut and packed in desired shapes and sizes. Intervention 2: Control group: This group will take a bar with no amounts of beetroot powder. All conditions of work are similar to the intervention group, only here the formulation of the produced bar does not contain beetroot extract.</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 sdff</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Mohammad Nejatian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vanak Square, MollaSadra st, Sheykh Bahayi st</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915371</zip>
        <telephone>+98 21 8755 5516</telephone>
        <email>m.nejatian@bmsu.ac.ir</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Mohammad Nejatian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vanak Square, MollaSadra st, Sheykh Bahayi st</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915371</zip>
        <telephone>+98 21 8755 5516</telephone>
        <email>m.nejatian@bmsu.ac.ir</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Studying student
Not having a history of cardiovascular diseases
No history of bone fractures and joint diseases
No smoking and drinking alcohol</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>All students who cannot do exercise tests at the time of study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This group consumes the designed functional bars 3 hours before the test. Three hours after eating the bar, people will not do any physical activity. The nutritional bars of the present study without surface coating and topping will be prepared by Zarcom Company (Tehran, Iran). The weight of the resulting bar will be determined depending on the amount of nitrate in the beetroot powder (approximately 1.4 mmol/70 grams). The first step in the process of making the nutritional bar involves mixing the liquid ingredients, which include high fructose corn syrup (or honey) and peanut butter. These components are mixed in a regular mixer. The next step in the process is adding the partially dry ingredients to the liquid mixture and stirring to achieve substantial uniformity. Partial dry ingredients are sesame seeds and salt. The third step of the process in the formation of the nutritional bar is the addition of the main dry ingredients to the mixture of the second step of the process. The main dry ingredients are sugar, wheat or barley grains. These components are mixed to obtain a completely homogeneous mixture that does not require drying to form. Then the mixture is compressed in a container covered with oil paper and allowed to form a mold. Bars are cut and packed in desired shapes and sizes.</i_keyword>
      <i_keyword>Control group: This group will take a bar with no amounts of beetroot powder. All conditions of work are similar to the intervention group, only here the formulation of the produced bar does not contain beetroot extract.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cardiorespiratory fitness. Timepoint: Before and three hours after the intervention. Method of measurement: Two mile or 3200 meter running test.</prim_outcome>
      <prim_outcome>Endurance of back arm and chest muscles. Timepoint: Before and three hours after the intervention. Method of measurement: With the swimming test on the hand for two minutes.</prim_outcome>
      <prim_outcome>Abdominal muscle endurance. Timepoint: Before and three hours after the intervention. Method of measurement: With the test of sitting for two minutes.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-20</approval_date>
        <contact_name>Ethical Committee of Baqiyatullah Al-Azam Educational and Medical Center</contact_name>
        <contact_address>Vanak Square, MollaSadra st, Sheykh Bahayi st Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
