xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05974813</url>
    </required_header>
    <id_info>
      <org_study_id>EUC_cit</org_study_id>
      <nct_id>NCT05974813</nct_id>
    </id_info>
    <brief_title>The Effect of Short-term L-citrulline Supplementation on Blood Pressure and Arterial Stiffness</brief_title>
    <official_title>The Effect of Short-term L-citrulline Supplementation on Blood Pressure and Arterial Stiffness</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>European University Cyprus</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>European University Cyprus</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to examine the effect of short-term L-Citrulline on&#xD;
        central and peripheral blood pressure in healthy older adults. The main questions it aims to&#xD;
        answer are:&#xD;
  &#xD;
          -  Does L-citrulline favorably affect blood pressure at rest and during exercise?&#xD;
  &#xD;
          -  Does L-citrulline favorably affect arterial stiffness?&#xD;
  &#xD;
          -  Does L-citrulline favorably affect muscle oxygenation at rest and during exercise?&#xD;
  &#xD;
        Participants will be asked to consume L-citrulline and a placebo for six days and participate&#xD;
        in the evaluation of their blood pressure, arterial stiffness, and muscle oxygenation before&#xD;
        and after each intervention.&#xD;
  &#xD;
        Researchers will compare L-citrulline and placebo groups to examine whether L-citrulline&#xD;
        supplementation affects the above health parameters.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Actual">March 1, 2023</completion_date>
    <primary_completion_date type="Actual">March 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in aortic and brachial systolic blood pressure (rest)</measure>
      <time_frame>Change from baseline aortic and brachial systolic blood pressure at 7 days.</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in aortic and brachial systolic blood pressure</measure>
      <time_frame>Change from baseline aortic and brachial systolic blood pressure at the second minute of exercise.</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in carotid-femoral pulse wave velocity (cfPWV) (rest)</measure>
      <time_frame>Change from baseline aortic and brachial systolic blood pressure at 7 days.</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in pulse pressure (rest)</measure>
      <time_frame>Change from baseline pulse pressure at 7 days.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in heart rate (rest)</measure>
      <time_frame>Change from baseline heart rate at 7 days.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in augmented pressure (rest)</measure>
      <time_frame>Change from baseline augmented pressure at 7 days.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in augmentation index (rest)</measure>
      <time_frame>Change from baseline augmentation index at 7 days.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in forward and backward wave pressure (rest)</measure>
      <time_frame>Change from baseline forward and backward wave pressure at 7 days.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in muscle oxyhemoglobin (rest)</measure>
      <time_frame>Change from baseline oxyhemoglobin at 7 days.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in pulse pressure (exercise)</measure>
      <time_frame>Change from baseline pulse pressure at the second minute of exercise.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in heart rate (exercise)</measure>
      <time_frame>Change from baseline heart rate at the second minute of exercise.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in augmented pressure (exercise)</measure>
      <time_frame>Change from baseline augmented pressure at the second minute of exercise.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in augmentation index (exercise)</measure>
      <time_frame>Change from baseline augmentation index at the second minute of exercise.</time_frame>
      <description>The ideal augmentation index is between 20 and 80. Values above 80 are considered high, and above 121 indicate high arterial stiffness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in forward and backward wave pressure (exercise)</measure>
      <time_frame>Change from baseline forward and backward wave pressure at the second minute of exercise.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in muscle deoxyhemoglobin (exercise)</measure>
      <time_frame>Change from baseline muscle deoxyhemoglobin at the second minute of exercise.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in muscle deoxyhemoglobin (rest)</measure>
      <time_frame>Change from baseline muscle deoxyhemoglobin at 7 days.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in muscle oxyhemoglobin (exercise)</measure>
      <time_frame>Change from baseline muscle oxyhemoglobin at the second minute of exercise.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in muscle oxyhemoglobin (rest)</measure>
      <time_frame>Change from baseline muscle oxyhemoglobin at 7 days.</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">12</enrollment>
    <condition>Blood Pressure</condition>
    <arm_group>
      <arm_group_label>L-Citrulline</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 6 g (3 g every 12 h) of L-citrulline (Now, L-citrulline Pure Powder) for six-days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will receive 6 g (3 g every 12 h) of maltodextrin (Now, Maltodextrin) for six-days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>L-Citrulline</intervention_name>
      <description>6 g (3 g every 12 h) of L-citrulline for six days</description>
      <arm_group_label>L-Citrulline</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>6 g (3 g every 12 h) of maltodextrin for six days</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  subject provides written informed consent.&#xD;
  &#xD;
            -  normal health profile.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  history of musculoskeletal injury in the legs during the previous six months.&#xD;
  &#xD;
            -  smoker.&#xD;
  &#xD;
            -  consumption of any medication the last three months.&#xD;
  &#xD;
            -  consumption of any nutritional supplement the last three months.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marios Vryonides, Dr.</last_name>
      <role>Study Director</role>
      <affiliation>European University Cyprus</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>European University Cyprus</name>
        <address>
          <city>Nicosia</city>
          <zip>1516</zip>
          <country>Cyprus</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Cyprus</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>European University Cyprus</investigator_affiliation>
      <investigator_full_name>Dr. Anastasios Theodorou</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05974813
  org study id: EUC_cit
  nct id: NCT05974813
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to examine the effect of short-term L-Citrulline on
        central and peripheral blood pressure in healthy older adults. The main questions it aims to
        answer are:
  
          -  Does L-citrulline favorably affect blood pressure at rest and during exercise?
  
          -  Does L-citrulline favorably affect arterial stiffness?
  
          -  Does L-citrulline favorably affect muscle oxygenation at rest and during exercise?
  
        Participants will be asked to consume L-citrulline and a placebo for six days and participate
        in the evaluation of their blood pressure, arterial stiffness, and muscle oxygenation before
        and after each intervention.
  
        Researchers will compare L-citrulline and placebo groups to examine whether L-citrulline
        supplementation affects the above health parameters.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Change in aortic and brachial systolic blood pressure (rest)
  time frame: Change from baseline aortic and brachial systolic blood pressure at 7 days.
  measure: Change in aortic and brachial systolic blood pressure
  time frame: Change from baseline aortic and brachial systolic blood pressure at the second minute of exercise.
  measure: Change in carotid-femoral pulse wave velocity (cfPWV) (rest)
  time frame: Change from baseline aortic and brachial systolic blood pressure at 7 days.
  measure: Change in pulse pressure (rest)
  time frame: Change from baseline pulse pressure at 7 days.
  measure: Change in heart rate (rest)
  time frame: Change from baseline heart rate at 7 days.
  measure: Change in augmented pressure (rest)
  time frame: Change from baseline augmented pressure at 7 days.
  measure: Change in augmentation index (rest)
  time frame: Change from baseline augmentation index at 7 days.
  measure: Change in forward and backward wave pressure (rest)
  time frame: Change from baseline forward and backward wave pressure at 7 days.
  measure: Change in muscle oxyhemoglobin (rest)
  time frame: Change from baseline oxyhemoglobin at 7 days.
  measure: Change in pulse pressure (exercise)
  time frame: Change from baseline pulse pressure at the second minute of exercise.
  measure: Change in heart rate (exercise)
  time frame: Change from baseline heart rate at the second minute of exercise.
  measure: Change in augmented pressure (exercise)
  time frame: Change from baseline augmented pressure at the second minute of exercise.
  measure: Change in augmentation index (exercise)
  time frame: Change from baseline augmentation index at the second minute of exercise.
  description: The ideal augmentation index is between 20 and 80. Values above 80 are considered high, and above 121 indicate high arterial stiffness.
  measure: Change in forward and backward wave pressure (exercise)
  time frame: Change from baseline forward and backward wave pressure at the second minute of exercise.
  measure: Change in muscle deoxyhemoglobin (exercise)
  time frame: Change from baseline muscle deoxyhemoglobin at the second minute of exercise.
  measure: Change in muscle deoxyhemoglobin (rest)
  time frame: Change from baseline muscle deoxyhemoglobin at 7 days.
  measure: Change in muscle oxyhemoglobin (exercise)
  time frame: Change from baseline muscle oxyhemoglobin at the second minute of exercise.
  measure: Change in muscle oxyhemoglobin (rest)
  time frame: Change from baseline muscle oxyhemoglobin at 7 days.
  arm group label: L-Citrulline
  arm group type: Experimental
  description: Participants will receive 6 g (3 g every 12 h) of L-citrulline (Now, L-citrulline Pure Powder) for six-days.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants will receive 6 g (3 g every 12 h) of maltodextrin (Now, Maltodextrin) for six-days.
  intervention type: Dietary Supplement
  intervention name: L-Citrulline
  description: 6 g (3 g every 12 h) of L-citrulline for six days
  arm group label: L-Citrulline
  intervention type: Dietary Supplement
  intervention name: Placebo
  description: 6 g (3 g every 12 h) of maltodextrin for six days
  arm group label: Placebo
  criteria: 
  gender: Male
  gender based: Yes
  minimum age: 55 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Marios Vryonides, Dr.
  role: Study Director
  affiliation: European University Cyprus
  facility: 
  country: Cyprus
  responsible party type: Principal Investigator
  investigator affiliation: European University Cyprus
  investigator full name: Dr. Anastasios Theodorou
  investigator title: Associate Professor
  sharing ipd: No