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/NCT05998603</url>
    </required_header>
    <id_info>
      <org_study_id>1076/MODREC/20B</org_study_id>
      <nct_id>NCT05998603</nct_id>
    </id_info>
    <brief_title>Pre-sleep Protein Supplementation and Load Carriage Recovery in British Army Recruits</brief_title>
    <official_title>Pre-sleep Protein Supplementation Does Not Improve Recovery From Load Carriage in British Army Recruits</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Anglia Ruskin University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Exeter</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Anglia Ruskin University</source>
    <oversight_info>
      <has_dmc>No</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>
        Load carriage is a common military activity and has been shown to induce acute&#xD;
        exercise-induced muscle damage (EIMD) and impair muscle function. Protein supplementation can&#xD;
        accelerate muscle recovery by attenuating EIMD and muscle function loss. This study&#xD;
        investigated the impact of an additional daily bolus of protein prior to sleep throughout&#xD;
        training on acute muscle recovery following a load carriage test in British Army recruits.&#xD;
        Muscle function (maximal jump height), perceived muscle soreness and urinary markers of&#xD;
        muscle damage were assessed before (PRE), immediately post (POST), 24-hours post (24h-POST)&#xD;
        and 40-hours post (40h-POST) a load carriage test.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        British Army basic training (BT) is physically demanding with new recruits completing&#xD;
        multiple bouts of physical activity each day with limited recovery. Load carriage is one of&#xD;
        the most physically demanding BT activities and has been shown to induce acute&#xD;
        exercise-induced muscle damage (EIMD) and impair muscle function. Protein supplementation can&#xD;
        accelerate muscle recovery by attenuating EIMD and muscle function loss. This study&#xD;
        investigated the impact of an additional daily bolus of protein prior to sleep throughout&#xD;
        training on acute muscle recovery following a load carriage test in United Kingdom (UK)&#xD;
        British Army recruits. A mixed group (men/women) over over 120 new recruits were randomised&#xD;
        to dietary control (CON), carbohydrate placebo (PLA), moderate (20g; MOD) or high (60g; HIGH)&#xD;
        protein supplementation. Muscle function (maximal jump height), perceived muscle soreness and&#xD;
        urinary markers of muscle damage were assessed before (PRE), immediately post (POST),&#xD;
        24-hours post (24h-POST) and 40-hours post (40h-POST) a load carriage test. The underlying&#xD;
        aim of this study was to assess whether additional protein intake could attenuate aspects of&#xD;
        muscle damage from an acute load carriage test including muscle function, muscle soreness and&#xD;
        biomarkers of muscle damage during short term recovery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 1, 2021</start_date>
    <completion_date type="Actual">May 31, 2022</completion_date>
    <primary_completion_date type="Actual">May 31, 2022</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>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in lower body muscle function</measure>
      <time_frame>40-hours</time_frame>
      <description>The change in maximal vertical jump height in participants before and after the load carriage test</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The change in urinary myoglobin</measure>
      <time_frame>40-hours</time_frame>
      <description>The relative change in concentration of urinary myoglobin (ng/ml) in participants before and after the load carriage test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in urinary 3-methylhistidine</measure>
      <time_frame>40-hours</time_frame>
      <description>The relative change in concentration of urinary 3-methylhistidine (nmol/ml) in participants before and after the load carriage test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in perceived muscle soreness</measure>
      <time_frame>40-hours</time_frame>
      <description>The relative change in perceived muscle soreness assessed via visual analogue scale</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">122</enrollment>
    <condition>Protein-energy; Imbalance</condition>
    <condition>Muscle Soreness</condition>
    <arm_group>
      <arm_group_label>High protein intake supplementation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A 60g daily dose of whey protein supplementation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Moderate protein intake supplementation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A 20g dose of whey protein supplementation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Carbohydrate placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>An isocaloic maltodextrin carbohydrate placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group, no supplementation</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Control group, not taking any supplementation, only completing basic training activities</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>High protein intake</intervention_name>
      <description>The participants received a 60g whey protein bolus each evening prior to sleep pre and post a military load carriage test.</description>
      <arm_group_label>High protein intake supplementation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Moderate protein intake</intervention_name>
      <description>The participants received a 20g whey protein bolus each evening prior to sleep pre and post a military load carriage test.</description>
      <arm_group_label>Moderate protein intake supplementation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Carbohydrate maltodextrin placebo</intervention_name>
      <description>The participants received an isocaloric carbohydrate bolus each evening prior to sleep pre and post a military load carriage test.</description>
      <arm_group_label>Carbohydrate placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control no supplementation</intervention_name>
      <description>Control group, no supplementation, only basic training</description>
      <arm_group_label>Control group, no supplementation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Enrolled into British Army basic training&#xD;
  &#xD;
            -  Medically fit to train and complete the load carriage test&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not taking any other nutritional supplement&#xD;
  &#xD;
            -  Pregnant&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Justin D Roberts, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Anglia Ruskin University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Anglia Ruskin University</name>
        <address>
          <city>Cambridge</city>
          <state>Cambridgeshire</state>
          <zip>CB1 1PT</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myalgia</mesh_term>
    </condition_browse>
    <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/NCT05998603
  org study id: 1076/MODREC/20B
  nct id: NCT05998603
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Load carriage is a common military activity and has been shown to induce acute
        exercise-induced muscle damage (EIMD) and impair muscle function. Protein supplementation can
        accelerate muscle recovery by attenuating EIMD and muscle function loss. This study
        investigated the impact of an additional daily bolus of protein prior to sleep throughout
        training on acute muscle recovery following a load carriage test in British Army recruits.
        Muscle function (maximal jump height), perceived muscle soreness and urinary markers of
        muscle damage were assessed before (PRE), immediately post (POST), 24-hours post (24h-POST)
        and 40-hours post (40h-POST) a load carriage test.
  British Army basic training (BT) is physically demanding with new recruits completing
        multiple bouts of physical activity each day with limited recovery. Load carriage is one of
        the most physically demanding BT activities and has been shown to induce acute
        exercise-induced muscle damage (EIMD) and impair muscle function. Protein supplementation can
        accelerate muscle recovery by attenuating EIMD and muscle function loss. This study
        investigated the impact of an additional daily bolus of protein prior to sleep throughout
        training on acute muscle recovery following a load carriage test in United Kingdom (UK)
        British Army recruits. A mixed group (men/women) over over 120 new recruits were randomised
        to dietary control (CON), carbohydrate placebo (PLA), moderate (20g; MOD) or high (60g; HIGH)
        protein supplementation. Muscle function (maximal jump height), perceived muscle soreness and
        urinary markers of muscle damage were assessed before (PRE), immediately post (POST),
        24-hours post (24h-POST) and 40-hours post (40h-POST) a load carriage test. The underlying
        aim of this study was to assess whether additional protein intake could attenuate aspects of
        muscle damage from an acute load carriage test including muscle function, muscle soreness and
        biomarkers of muscle damage during short term recovery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Participant)
  measure: Change in lower body muscle function
  time frame: 40-hours
  description: The change in maximal vertical jump height in participants before and after the load carriage test
  measure: The change in urinary myoglobin
  time frame: 40-hours
  description: The relative change in concentration of urinary myoglobin (ng/ml) in participants before and after the load carriage test
  measure: The change in urinary 3-methylhistidine
  time frame: 40-hours
  description: The relative change in concentration of urinary 3-methylhistidine (nmol/ml) in participants before and after the load carriage test
  measure: The change in perceived muscle soreness
  time frame: 40-hours
  description: The relative change in perceived muscle soreness assessed via visual analogue scale
  arm group label: High protein intake supplementation
  arm group type: Experimental
  description: A 60g daily dose of whey protein supplementation
  arm group label: Moderate protein intake supplementation
  arm group type: Experimental
  description: A 20g dose of whey protein supplementation
  arm group label: Carbohydrate placebo
  arm group type: Placebo Comparator
  description: An isocaloic maltodextrin carbohydrate placebo
  arm group label: Control group, no supplementation
  arm group type: Other
  description: Control group, not taking any supplementation, only completing basic training activities
  intervention type: Dietary Supplement
  intervention name: High protein intake
  description: The participants received a 60g whey protein bolus each evening prior to sleep pre and post a military load carriage test.
  arm group label: High protein intake supplementation
  intervention type: Dietary Supplement
  intervention name: Moderate protein intake
  description: The participants received a 20g whey protein bolus each evening prior to sleep pre and post a military load carriage test.
  arm group label: Moderate protein intake supplementation
  intervention type: Dietary Supplement
  intervention name: Carbohydrate maltodextrin placebo
  description: The participants received an isocaloric carbohydrate bolus each evening prior to sleep pre and post a military load carriage test.
  arm group label: Carbohydrate placebo
  intervention type: Other
  intervention name: Control no supplementation
  description: Control group, no supplementation, only basic training
  arm group label: Control group, no supplementation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Justin D Roberts, PhD
  role: Principal Investigator
  affiliation: Anglia Ruskin University
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Myalgia
  sharing ipd: No