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/NCT05993715</url>
    </required_header>
    <id_info>
      <org_study_id>5951</org_study_id>
      <nct_id>NCT05993715</nct_id>
    </id_info>
    <brief_title>Nitrate Supplementation on Motor Unit Activity</brief_title>
    <official_title>Influence of Nitrate Supplementation on Motor Unit Activity During Recovery Following a Sustained Ischemic Contraction.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Northumbria University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Manchester Metropolitan University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Northumbria University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aimed to assess if nitrate supplementation influence motor unit (MU) activity&#xD;
        following a sustained ischemic contraction and whether this is affected by blood flow&#xD;
        restriction (BFR) during the recovery period. Fourteen male participants (mean ± SD, 25 ± 6&#xD;
        years) completed two experimental trials following 5-days of supplementation with either&#xD;
        nitrate-rich (NIT) or nitrate-depleted (PLA) beetroot juice in a randomized, double-blinded,&#xD;
        cross-over design. Intramuscular electromyography was used to assess MU potential (MUP) size&#xD;
        and firing rates (MUFR) during a submaximal (25% MVC) sustained isometric contraction with&#xD;
        BFR. These variables were also assessed during a 90 s recovery period with the first half&#xD;
        completed with, and the second half completed without, BFR. Nitrate supplementation can&#xD;
        expedite the recovery of MUP duration following a sustained ischemic contraction in healthy&#xD;
        adults. These novel observations improve understanding of the effects of nitrate on the&#xD;
        recovery of neuromuscular function post-exercise and might have implications for recovery of&#xD;
        muscle contractile function.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 4, 2019</start_date>
    <completion_date type="Actual">March 1, 2020</completion_date>
    <primary_completion_date type="Actual">February 3, 2020</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>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Supplements were allocated in a randomised order and double-blind design by an independent technician who had no further involvement in this study. The randomization and blinding were held until the end of the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Plasma Nitrite Level</measure>
      <time_frame>Pre-exercise</time_frame>
      <description>concentration [nmol]</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Motor Unit Activity</measure>
      <time_frame>Pre-exercise, post-exercise, recovery (45 s)</time_frame>
      <description>Duration (ms), area (uV.ms), firing rate (Hz)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">14</enrollment>
    <condition>Dietary Supplements</condition>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Nitrate supplementation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>2 × 70 mL/day shots of concentrate nitrae-rich (~12.8 mmol/day NO3-) beetroot juice. Two shots were supplemented for 5 days; one each morning (~9 am) and one each evening (~9 pm) except for the day of the experimental trial when both shots were taken together 2.5 h before the experimental trial.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo supplementation</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>2 × 70 mL/day shots of concentrate nitrate-depleted (~0.08 mmol/day NO3-) beetroot juice. Two shots were supplemented for 5 days; one each morning (~9 am) and one each evening (~9 pm) except for the day of the experimental trial when both shots were taken together 2.5 h before the experimental trial.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Nitrate supplementation</intervention_name>
      <description>Participants ingested 2 × 70 mL/day shots of concentrate nitrate-rich (~12.8 mmol/day nitrate) or nitrate-depleted (~0.08 mmol/day nitrite) beetroot juice (Beet It, James White Drinks Ltd., Ipswich, UK). Two shots were supplemented for 5 days; one each morning (~9 am) and one each evening (~9 pm) except for the day of the experimental trial when both shots were taken together 2.5 h before the experimental trial.</description>
      <arm_group_label>Nitrate supplementation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo supplementtaion</intervention_name>
      <description>2 × 70 mL/day shots of concentrate nitrate-depleted (~0.08 mmol/day NO3-) beetroot juice. Two shots were supplemented for 5 days; one each morning (~9 am) and one each evening (~9 pm) except for the day of the experimental trial when both shots were taken together 2.5 h before the experimental trial.</description>
      <arm_group_label>Placebo supplementation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male between 18 - 30 years&#xD;
  &#xD;
            -  free from known respiratory insufficiency, cardiovascular disease and&#xD;
               neuro-musculo-skeletal problems at present or in the preceding 6 months.&#xD;
  &#xD;
            -  having at least 5 years competitively (team) sport experience.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  having cardiovascular disease, neuromuscular disease and any lower limb injury and&#xD;
               treatment for chronic respiratory complaints.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Northumbria University</name>
        <address>
          <city>Newcastle Upon Tyne</city>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Northumbria University</investigator_affiliation>
      <investigator_full_name>Dr Ozcan Esen</investigator_full_name>
      <investigator_title>Assistant 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/NCT05993715
  org study id: 5951
  nct id: NCT05993715
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This study aimed to assess if nitrate supplementation influence motor unit (MU) activity
        following a sustained ischemic contraction and whether this is affected by blood flow
        restriction (BFR) during the recovery period. Fourteen male participants (mean ± SD, 25 ± 6
        years) completed two experimental trials following 5-days of supplementation with either
        nitrate-rich (NIT) or nitrate-depleted (PLA) beetroot juice in a randomized, double-blinded,
        cross-over design. Intramuscular electromyography was used to assess MU potential (MUP) size
        and firing rates (MUFR) during a submaximal (25% MVC) sustained isometric contraction with
        BFR. These variables were also assessed during a 90 s recovery period with the first half
        completed with, and the second half completed without, BFR. Nitrate supplementation can
        expedite the recovery of MUP duration following a sustained ischemic contraction in healthy
        adults. These novel observations improve understanding of the effects of nitrate on the
        recovery of neuromuscular function post-exercise and might have implications for recovery of
        muscle contractile function.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: Double (Participant, Investigator)
  masking description: Supplements were allocated in a randomised order and double-blind design by an independent technician who had no further involvement in this study. The randomization and blinding were held until the end of the study.
  measure: Plasma Nitrite Level
  time frame: Pre-exercise
  description: concentration [nmol]
  measure: Motor Unit Activity
  time frame: Pre-exercise, post-exercise, recovery (45 s)
  description: Duration (ms), area (uV.ms), firing rate (Hz)
  arm group label: Nitrate supplementation
  arm group type: Experimental
  description: 2 × 70 mL/day shots of concentrate nitrae-rich (~12.8 mmol/day NO3-) beetroot juice. Two shots were supplemented for 5 days; one each morning (~9 am) and one each evening (~9 pm) except for the day of the experimental trial when both shots were taken together 2.5 h before the experimental trial.
  arm group label: Placebo supplementation
  arm group type: Placebo Comparator
  description: 2 × 70 mL/day shots of concentrate nitrate-depleted (~0.08 mmol/day NO3-) beetroot juice. Two shots were supplemented for 5 days; one each morning (~9 am) and one each evening (~9 pm) except for the day of the experimental trial when both shots were taken together 2.5 h before the experimental trial.
  intervention type: Dietary Supplement
  intervention name: Nitrate supplementation
  description: Participants ingested 2 × 70 mL/day shots of concentrate nitrate-rich (~12.8 mmol/day nitrate) or nitrate-depleted (~0.08 mmol/day nitrite) beetroot juice (Beet It, James White Drinks Ltd., Ipswich, UK). Two shots were supplemented for 5 days; one each morning (~9 am) and one each evening (~9 pm) except for the day of the experimental trial when both shots were taken together 2.5 h before the experimental trial.
  arm group label: Nitrate supplementation
  intervention type: Dietary Supplement
  intervention name: Placebo supplementtaion
  description: 2 × 70 mL/day shots of concentrate nitrate-depleted (~0.08 mmol/day NO3-) beetroot juice. Two shots were supplemented for 5 days; one each morning (~9 am) and one each evening (~9 pm) except for the day of the experimental trial when both shots were taken together 2.5 h before the experimental trial.
  arm group label: Placebo supplementation
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: Northumbria University
  investigator full name: Dr Ozcan Esen
  investigator title: Assistant Professor
  sharing ipd: No