<?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>IRCT20230304057606N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-16</date_registration>
      <primary_sponsor>The university of gilan</primary_sponsor>
      <public_title>Investigating the effect of hydrogen-rich water on active young men.</public_title>
      <acronym></acronym>
      <scientific_title>Effect of hydrogen rich water consumption and exhaustive exercise activity under induced hypoxia conditions with facial mask on serum malondialdehyde level and total antioxidant capacity, blood pressure and rate pressure product in active young men.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68979</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Health service research, Blinding description: The researcher is unaware of which people are in the intervention group and which are in the control group. The task of preparing hydrogen-rich water is the responsibility of the researcher, but he does not know which bottle will be given to which person. The participants know that he will consume hydrogen-rich water in the research, but he doesn't know that the water he consumes is normal mineral water or hydrogen rich water. (Alkaline sticks do not cause any color or taste changes in mineral water, so hydrogen-rich water and placebo look the same). The second person, as a research assistant, will control and implement this case based on a defined coding system.</study_design>
      <phase>N/A</phase>
      <hc_freetext>determination of serum malondialdehyde level; total antioxidant capacity; rate pressure product after consumption of hydrogen-rich water in active young men.</hc_freetext>
      <i_freetext>Intervention 1: We have two groups of 12 participants in the project, who are randomly divided into the intervention group and the control group. The first or intervention group consumes hydrogen-rich water. and 1.5 liters of water will be used in the form of half a liter before training, half a liter in the morning of the training day and half a liter 10 minutes before training. Intervention 2: The second group uses either placebo control or ordinary mineral water. The exercises and conditions of drinking mineral water will be the same as the intervention 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 further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soheila Khodadadikateshoori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.28, Shir Mohammadi Ave, Emam Blvd</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4188693139</zip>
        <telephone>+98 13 3332 6958</telephone>
        <email>S_khodadadi_0@yahoo.com</email>
        <affiliation>The university of Gillan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soheila Khodadadikateshoori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 28 ,shirmohammadi Ave. ,Emamkhomaini Blvd.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4188693139</zip>
        <telephone>+98 13 3332 6958</telephone>
        <email>S_khodadadi_0@yahoo.com</email>
        <affiliation>The University of guilan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People should be in perfect health.
People who participate in the study will have normal blood pressure.
Absence of any hormonal or inflammatory disease to affect blood pressure or antioxidant capacity.
Absence of respiratory diseases due to the effect of the mask on the severity of the disease and heart rate during physical activity.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>32 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Subjects were excluded from the study if their mean systolic and/or diastolic blood pressure was equal to or greater than 140- and 90-mm Hg, respectively.
Body mass index above 25
Hormonal diseases
Inflammatory diseases
respiratory diseases
catching a cold
Taking any medication, including steroidal and non-steroidal anti-inflammatory drugs (aspirin family), pharmaceutical and food supplements</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>We have two groups of 12 participants in the project, who are randomly divided into the intervention group and the control group. The first or intervention group consumes hydrogen-rich water. and 1.5 liters of water will be used in the form of half a liter before training, half a liter in the morning of the training day and half a liter 10 minutes before training.</i_keyword>
      <i_keyword>The second group uses either placebo control or ordinary mineral water. The exercises and conditions of drinking mineral water will be the same as the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Malondialdehyde serum level and total antioxidant capacity after residual exercise after consumption of 3 servings of hydrogen-rich water. Timepoint: Blood sampling will be done ten minutes before the start of the physical activity and immediately after the end of the physical activity. Method of measurement: Measurements will be done in the laboratory using the malondialdehyde and total antioxidant capacity assay kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Total antioxidant capacity serum level. Timepoint: Taking a blood sample ten minutes before starting physical activity and immediately after physical activity. Method of measurement: Using the measurement kit in the laboratory.</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>The university of gilan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-28</approval_date>
        <contact_name>Research Ethics Committee of Gillan University</contact_name>
        <contact_address>km 6 of Tehran road rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
