<?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>IRCT20200707048041N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-23</date_registration>
      <primary_sponsor>National Olympic Academy</primary_sponsor>
      <public_title>Evaluation of vasodilatory changes and exercise performance to caffeine-beet juice supplementation in runners</public_title>
      <acronym></acronym>
      <scientific_title>The effect of short-term supplementation of caffeine and beet juice with high, low dose and placebo on vasodilator indices and athletic performance in elite runners</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49502</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Other design features: Design the use of combination supplements with simultaneous random, cross-sectional, and Three-way blind intervention, Randomization description: First, the total sample size of 30 people consisting of members of the national endurance athletics team of the country who met the conditions in the descriptive questionnaire and had physical, health and sports conditions were determined. Then they were divided into 3 random groups so that their names were written in the same way on the same sheets and 10 of them were selected by an unrelated person for each group and divided into three groups. The names were randomly determined without replacement from the container and the order of supplementation was determined, Blinding description: Subjects participating in the project, as well as the researcher who did not know the type of supplement offered to the subjects, and the collection was done only based on the number of each group and the analytical laboratory not knew the names of the individuals in each intervention group and the type of supplement they consumed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Changes in nitrite, collagen 18, nitrous oxide, endothelin-1, systolic blood pressure, diastolic blood pressure and heart rate in professional runners due to caffeine-beet juice supplementation.</hc_freetext>
      <i_freetext>Intervention 1: IIntervention and control group 1: High dose of combined supplement (9.6 mmol nitrate in beet juice made by Sensei Pharmaceutical Company and 400 mg of caffeine made by Karen Pharmaceutical Company) which is combined with 250 cc of water. The group received all three complementary doses crossover and randomly, so each intervention group is considered as its control group. Intervention 2: Intervention and control group 2: Low dose of combined supplement (4.8 mmol nitrate in beet juice made by Sensai Pharmaceutical Company and 200 mg of caffeine made by Karen Pharmaceutical Company) combined with 250 cc of water. Due to the fact that all three groups received all three complementary doses crossover and randomly, each intervention group is considered as its control group. Intervention 3: Intervention and control group 3: placebo group Natural beet juice with 1 mmol nitrate and decaffeinated. Due to the fact that all three groups received all three complementary doses crossover and randomly, each intervention group is considered as its 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There are no plans to publish. If a researcher needs the information of the participants, he / she can contact the person in charge of the article or the editor of the publication where the article is published, so that the participants can provide details if they wish.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hadi Atarod</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Science and Research Branch, Islamic Azad University, University Square, Hesarak Boulevard, pounak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 2621 6193</telephone>
        <email>atarodsportnutrition@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Farshad Ghazalian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Science and Research Branch، Islamic Azad University، University Square، Hesarak Boulevard، pounak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>0098 21 44865179-82</telephone>
        <email>phdghazalian@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No history of metabolic disease
No history of smoking
Intolerance to beet juice, caffeine or other natural stimulants
Do not use the drug during the research period
Young elite male runners
Ability to perform aerobic activity</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having metabolic diseases such as heart disease and hypertension
History of drug use
History of tobacco use
Having an intolerance to caffeine
Having an intolerance to beet-root juice
Non-runner
Female gender</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>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>IIntervention and control group 1: High dose of combined supplement (9.6 mmol nitrate in beet juice made by Sensei Pharmaceutical Company and 400 mg of caffeine made by Karen Pharmaceutical Company) which is combined with 250 cc of water. The group received all three complementary doses crossover and randomly, so each intervention group is considered as its control group.</i_keyword>
      <i_keyword>Intervention and control group 2: Low dose of combined supplement (4.8 mmol nitrate in beet juice made by Sensai Pharmaceutical Company and 200 mg of caffeine made by Karen Pharmaceutical Company) combined with 250 cc of water. Due to the fact that all three groups received all three complementary doses crossover and randomly, each intervention group is considered as its control group.</i_keyword>
      <i_keyword>Intervention and control group 3: placebo group Natural beet juice with 1 mmol nitrate and decaffeinated. Due to the fact that all three groups received all three complementary doses crossover and randomly, each intervention group is considered as its control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rate. Timepoint: The first and seventh days before and after two 5 km, which lasts a total of 14 days for each stage of the intervention. This protocol is repeated in three stages and the consumption of supplements and subjects is changed. Method of measurement: Holter.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: The first and seventh days before and after two 5 km, which lasts a total of 14 days for each stage of the intervention. This protocol is repeated in three stages and the consumption of supplements and subjects is changed. Method of measurement: Mercury barometer.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: The first and seventh days before and after two 5 km, which lasts a total of 14 days for each stage of the intervention. This protocol is repeated in three stages and the consumption of supplements and subjects is changed. Method of measurement: Mercury barometer.</prim_outcome>
      <prim_outcome>Nitrate. Timepoint: The first, second, seventh and eighth days of the intervention in the first phase of the intervention, which lasts a total of 14 days. This protocol is repeated in three stages and the consumption of supplements and subjects is changed. Method of measurement: Blood sampling.</prim_outcome>
      <prim_outcome>Nitric oxide. Timepoint: The first, second, seventh and eighth days of the intervention in the first phase of the intervention, which lasts a total of 14 days. This protocol is repeated in three stages and the consumption of supplements and subjects is changed. Method of measurement: Blood sampling.</prim_outcome>
      <prim_outcome>Collagen 18. Timepoint: The first, second, seventh and eighth days of the intervention in the first phase of the intervention, which lasts a total of 14 days. This protocol is repeated in three stages and the consumption of supplements and subjects is changed. Method of measurement: Blood sampling.</prim_outcome>
      <prim_outcome>Endothelin 1. Timepoint: The first, second, seventh and eighth days of the intervention in the first phase of the intervention, which lasts a total of 14 days. This protocol is repeated in three stages and the consumption of supplements and subjects is changed. Method of measurement: Blood sampling.</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>National Olympic Academy</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-21</approval_date>
        <contact_name>Ethics Committee in Research، Islamic Azad University, Science and Research Branch</contact_name>
        <contact_address>Research Sciences Branch، Islamic Azad University، Hesarak St، Punak Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
