<?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>IRCT20250517065774N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-13</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Arginine supplementation along with spirulina and HIIT training affects athletic performance, inflammatory indices, and oxidative stress in female water polo players.</public_title>
      <acronym></acronym>
      <scientific_title>Effects of arginine supplementation along with spirulina and HIIT training on athletic performance, inflammatory indices, and oxidative stress in female water polo players.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>27</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/92397</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: In order to use the random number table, the researcher will first determine the reading direction of the table numbers. Then the numbers will be considered for different groups. For example: numbers 14-00 for group A, numbers 15-29 for intervention B, numbers 30-44 for group C. Then we will place our hand on one of the numbers and move in one of the predetermined directions. The numbers will be recorded and assigned to three groups: L-arginine + spirulina supplement consumption, HIIT training, and L-arginine + spirulina supplement consumption + HIIT training. In order to conceal the random assignment, the coded box method with a random sequence will be used. In this method, a number of boxes that are numbered based on a random sequence are used. It will be ensured that the boxes are adequately sealed and waxed, that they are similar in appearance, and that they are of the same weight, Blinding description: In this study, the analyst, statistician, assistant professor, trainer, and exercise physiologist were blinded to the entire study process. The blinding process included concealment of allocation through sealed envelopes and supplement intake, standardized exercise protocols, and outcome assessment by an independent, blinded team with automated digital devices, along with a controlled disclosure mechanism designed for emergencies. To blind the intake of supplements, all participants were given dark bottles during the interventions so that the color of the drink was not visible.</study_design>
      <phase>1</phase>
      <hc_freetext>Sports performance, inflammatory markers, and oxidative stress in female water polo players..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Supplement (L-arginine + Spirulina): L-arginine, as a precursor of nitric oxide (NO) synthesis, plays a key role in vasodilation (widening of blood vessels) and oxygen transport. Based on standard protocols of similar studies on athletes and to achieve optimal physiological effects, the daily dose of L-arginine is considered to be 6 grams per day. This amount is usually divided into two doses of 3 grams to avoid possible digestive problems. Participants should dissolve L-arginine powder or capsules with 300 ml of water and consume. The first dose (3 grams) is consumed 60 minutes before the training session (to increase blood flow and nutrient transport during training) and the second dose (3 grams) is consumed at breakfast or before bedtime (to improve tissue repair and recovery). On non-training days, both doses are consumed with the morning and evening meals. Spirulina, a red algae rich in protein, phycocyanin, and potent antioxidants, is prescribed to modulate oxidative stress and inflammatory responses induced by high-intensity exercise. The daily dose of spirulina is considered to be 3 grams per day. This dose has been shown to be effective in several studies for its protective effects against muscle damage. Spirulina powder or standardized tablets should be taken with a full glass of water. Due to its absorption nature and antioxidant effects, it is recommended to take spirulina 30 minutes before breakfast. This timing allows for better absorption of phytonutrients and provides systemic antioxidants throughout the training day. To reduce bias, this study will be double-blinded, meaning that neither the participants nor the researchers responsible for conducting the tests will be aware of the contents of the capsules or powders (the main supplement or the placebo, which is usually maltodextrin). To ensure adherence to the protocol, participants receive a logbook to record when supplements are taken and any potential gastrointestinal side effects. Regular (weekly) meetings are held to retrieve used supplement packages and count the number of capsules remaining to assess athlete compliance with the treatment protocol. Intervention 2: Intervention group: HIIT training: Participants will perform HIIT training in water three times a week for 8 weeks. The intensity of the training is adjusted based on maximum heart rate (HRmax) and monitored with a monitoring device. The training program is designed based on the physiological principles of water polo. The intervention training groups will perform HIIT training for 8 weeks, 6 days a week. Each training session will consist of two parts: land-based training and water-based training. The first part will consist of strength training (about 4 times a week) and the second part, which will be performed about 30 minutes later, will consist of swimming training (about 5 times a week) and specialized water polo training. The intensity of swimming training will be determined based on the Maglischo classification into four zones: below the anaerobic threshold (End-1), above the anaerobic threshold (End-2), above the anaerobic threshold (End-3), and maximum speed effort (Sprint). Internal training load is monitored in all sessions using the rated perceived exertion (sRPE) method. Intervention 3: Intervention group: Combination group (L-arginine supplementation + spirulina + HIIT training).</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 En Undecided - It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Navid Abedpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>اصفهان، خیابان جی شرقی، ارغوانیه، بلوار دانشگاه</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>39998-81551</zip>
        <telephone>+98 31 3535 2900</telephone>
        <email>abedpoor.navid@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Navid Abedpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad Univesity Of Isfahan (Khorasgan) Branch -Daneshgah blvd, Arghavanieh, East Jey St, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>39998-81551</zip>
        <telephone>+98 31 3535 2900</telephone>
        <email>abedpoor.navid@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants must be selected from among female athletes in the youth age group (16 to 18 years old).
Having at least 2 years of professional and competitive experience in water polo and membership in teams in the country's first division league.
Participants must be members of the national championship team in the under-20 age group in the year of the study.
Not having any musculoskeletal injuries (such as muscle tears or shoulder or knee injuries) that would prevent you from performing strenuous exercise or physical tests.
Absence of chronic metabolic (such as diabetes), cardiovascular, respiratory, or inflammatory diseases that would affect physiological responses to training and supplementation.
No use of specific medications and supplements: No use of any anti-inflammatory drugs (steroidal or non-steroidal), antibiotics, orthogenic supplements (such as creatine or beta-alanine), or synthetic antioxidants during the past 3 months until the end of the study period.
Commitment to attend training sessions according to the team schedule, such that the percentage of training attendance during the study period is at least 85% (based on the average attendance of 87 ± 11% mentioned in the main text).
Completion of an informed consent form by the participant (or legal guardian if under 18 years of age) after receiving full explanations about the research objectives and process.</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Absence of more than 15% of training sessions or failure to complete the 8-week training intervention period.
Failure to comply with the supplementation protocol: Failure to regularly take L-arginine and spirulina supplements according to the study instructions (such as forgetting more than 20% of the prescribed doses).
Any acute injury during the study that prevents the participant from continuing with training or testing, or acute illness (such as severe flu or viral infections) that requires rest or medication.
Dietary or medication changes: Sudden and significant changes in diet, initiation of specific diets (such as ketogenic or vegan diets), or initiation of new medications that may interfere with study variables (such as inflammatory or hormonal markers).
Unwillingness or inability to provide blood or saliva samples at designated times (pre-test, mid-test, or post-test).
The willingness of the participant to leave the study at any point in time without having to provide a reason.
Performing strenuous exercise outside of the team's training program or participating in informal competitions that affect training load and oxidative stress.</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Supplement (L-arginine + Spirulina): L-arginine, as a precursor of nitric oxide (NO) synthesis, plays a key role in vasodilation (widening of blood vessels) and oxygen transport. Based on standard protocols of similar studies on athletes and to achieve optimal physiological effects, the daily dose of L-arginine is considered to be 6 grams per day. This amount is usually divided into two doses of 3 grams to avoid possible digestive problems. Participants should dissolve L-arginine powder or capsules with 300 ml of water and consume. The first dose (3 grams) is consumed 60 minutes before the training session (to increase blood flow and nutrient transport during training) and the second dose (3 grams) is consumed at breakfast or before bedtime (to improve tissue repair and recovery). On non-training days, both doses are consumed with the morning and evening meals. Spirulina, a red algae rich in protein, phycocyanin, and potent antioxidants, is prescribed to modulate oxidative stress and inflammatory responses induced by high-intensity exercise. The daily dose of spirulina is considered to be 3 grams per day. This dose has been shown to be effective in several studies for its protective effects against muscle damage. Spirulina powder or standardized tablets should be taken with a full glass of water. Due to its absorption nature and antioxidant effects, it is recommended to take spirulina 30 minutes before breakfast. This timing allows for better absorption of phytonutrients and provides systemic antioxidants throughout the training day. To reduce bias, this study will be double-blinded, meaning that neither the participants nor the researchers responsible for conducting the tests will be aware of the contents of the capsules or powders (the main supplement or the placebo, which is usually maltodextrin). To ensure adherence to the protocol, participants receive a logbook to record when supplements are taken and any potential gastrointestinal side effects. Regular (weekly) meetings are held to retrieve used supplement packages and count the number of capsules remaining to assess athlete compliance with the treatment protocol.</i_keyword>
      <i_keyword>Intervention group: HIIT training: Participants will perform HIIT training in water three times a week for 8 weeks. The intensity of the training is adjusted based on maximum heart rate (HRmax) and monitored with a monitoring device. The training program is designed based on the physiological principles of water polo. The intervention training groups will perform HIIT training for 8 weeks, 6 days a week. Each training session will consist of two parts: land-based training and water-based training. The first part will consist of strength training (about 4 times a week) and the second part, which will be performed about 30 minutes later, will consist of swimming training (about 5 times a week) and specialized water polo training. The intensity of swimming training will be determined based on the Maglischo classification into four zones: below the anaerobic threshold (End-1), above the anaerobic threshold (End-2), above the anaerobic threshold (End-3), and maximum speed effort (Sprint). Internal training load is monitored in all sessions using the rated perceived exertion (sRPE) method.</i_keyword>
      <i_keyword>Intervention group: Combination group (L-arginine supplementation + spirulina + HIIT training)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Repeated sprint ability test. Timepoint: At the beginning and end of 8 weeks of study. Method of measurement: To assess specialized fitness, the protocol was performed according to Tan et al. (2010). This protocol consisted of 4 sets of 6 10-meter swim sprints with 17 seconds of rest between sprints and 4 minutes of rest between sets. The timing of the sprints was recorded and analyzed with high precision using a digital camera and Kinovea software to calculate the best time, average time, and absolute and percentage reduction.</prim_outcome>
      <prim_outcome>Expression levels of inflammatory genes and oxidative stress. Timepoint: At the beginning and end of 8 weeks of study. Method of measurement: Real-time qPCR.</prim_outcome>
      <prim_outcome>Functional and physiological assessments. Timepoint: At the beginning and end of 8 weeks of study. Method of measurement: Performance tests are conducted in a 50-meter indoor pool with controlled temperature (29.5 ± 1.3°C). Before the test, participants perform a standard warm-up (10 minutes of low-to-moderate intensity swimming and short high-intensity stimulations) under the supervision of technical staff.</prim_outcome>
      <prim_outcome>Plasma glutathione, plasma superoxide dismutase, and plasma catalase concentrations. Timepoint: At the beginning and end of 8 weeks of study. Method of measurement: Elisa Kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart Rate Variability - HRV. Timepoint: At the beginning and end of 8 weeks of study. Method of measurement: In order to monitor the state of the autonomic nervous system and assess the level of recovery and physiological fitness of the athletes, the heart rate variability (HRV) index was measured during the study period. According to the research protocol, HRV assessments were performed three times a week and before any physical activity during the assessment weeks (the time interval between measurements was set between 24 and 48 hours).</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 University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-07-28</approval_date>
        <contact_name>Ethics Committee on Research Islamic Azad University - Isfahan Branch (Khorasgan)</contact_name>
        <contact_address>اصفهان، خیابان جی شرقی، ارغوانیه، بلوار دانشگاه ، اصفهان Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
