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/NCT05998590</url>
    </required_header>
    <id_info>
      <org_study_id>1076/MODREC/20</org_study_id>
      <nct_id>NCT05998590</nct_id>
    </id_info>
    <brief_title>Pre-sleep Protein Supplementation in British Army Recruits</brief_title>
    <official_title>Pre-sleep Protein Supplementation Does Not Improve Performance, Body Composition and Recovery 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>
        Dietary protein has been shown to be important to support physical training. For occupational&#xD;
        demands such as military training, new recruits often fail to meet the recommended protein&#xD;
        intake during basic training (BT), with negligible amounts consumed in the evening. As such,&#xD;
        individuals undertaking BT may require higher intakes than the general population.This study&#xD;
        assessed the influence of a daily bolus of protein prior to sleep on performance adaptations,&#xD;
        body composition and recovery in British Army recruits.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Dietary protein is crucial for optimising physical training adaptations such as muscular&#xD;
        strength and mass, which are key aims for athletic populations, including British Army&#xD;
        recruits. New recruits fail to meet the recommended protein intake during basic training&#xD;
        (BT), with negligible amounts consumed in the evening. This study aimed to assess the&#xD;
        influence of a daily bolus of protein prior to sleep on performance adaptations, body&#xD;
        composition and recovery in British Army recruits. The study will recruit a mixed cohort of&#xD;
        &gt;120 new recruits from the United Kingdom (UK) British Army who will be randomised into a&#xD;
        dietary control (CON), carbohydrate placebo (PLA), moderate (20g) protein (MOD) or high (60g)&#xD;
        protein (HIGH) supplementation group. Supplements will be isocaloric and consumed daily on&#xD;
        weekday evenings between 2000 and 2100h for 10 weeks during BT, alongside standardised&#xD;
        dietary intake and BT activities. Performance tests (mid-thigh pull, medicine ball throw, 2km&#xD;
        run time, maximal push-up and maximal vertical jump) and body composition will be assessed at&#xD;
        the start and end of BT under standardised conditions. Dietary intake, energy expenditure,&#xD;
        salivary hormones, urinary nitrogen balance, perceived muscle soreness, rating of perceived&#xD;
        exertion, mood and fatigue will be assessed at the start, middle and end of BT. The&#xD;
        underlying aim of this study is to assess whether inclusion of nocturnal protein&#xD;
        supplementation will influence performance adaptations, body composition changes or acute&#xD;
        recovery in British Army recruits.&#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>Lower body strength performance</measure>
      <time_frame>12 weeks</time_frame>
      <description>Mid-thigh pull</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Body composition</measure>
      <time_frame>12 weeks</time_frame>
      <description>Fat-free mass</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">122</enrollment>
    <condition>Protein-energy; Imbalance</condition>
    <condition>Recovery</condition>
    <condition>Body Weight</condition>
    <arm_group>
      <arm_group_label>High protein intake supplementation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A daily 60g dose of whey protein supplementation received between 8-9pm during BT.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Moderate protein intake supplementation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A daily 20g dose of whey protein supplementation received between 8-9pm during BT.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Carbohydrate placebo supplementation</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>A daily isocaloric carbohydrate (maltodextrin) placebo received between 8-9pm during BT.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Control group, no daily supplement received, only participating in BT.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>High protein supplement</intervention_name>
      <description>The participants received a 60g protein bolus each evening prior to sleep from week 3 to week 12 of training.</description>
      <arm_group_label>High protein intake supplementation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Moderate protein supplement</intervention_name>
      <description>The participants received a 20g protein bolus each evening prior to sleep from week 3 to week 12 of training.</description>
      <arm_group_label>Moderate protein intake supplementation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Carbohydrate placebo</intervention_name>
      <description>The participants received an isocaloric carbohydrate bolus each evening prior to sleep from week 3 to week 12 of training.</description>
      <arm_group_label>Carbohydrate placebo supplementation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control: No supplementation</intervention_name>
      <description>The participants did not receive any supplementation but instead acted as a control group doing BT only</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Enrolled into British Army basic training&#xD;
  &#xD;
            -  Medically fit to start Army training&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not taking any other nutritional supplement&#xD;
  &#xD;
            -  Not currently pregnant&#xD;
  &#xD;
            -  Not dairy or lactose intolerant or have any specific dietary requirements .&#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>Body Weight</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/NCT05998590
  org study id: 1076/MODREC/20
  nct id: NCT05998590
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Dietary protein has been shown to be important to support physical training. For occupational
        demands such as military training, new recruits often fail to meet the recommended protein
        intake during basic training (BT), with negligible amounts consumed in the evening. As such,
        individuals undertaking BT may require higher intakes than the general population.This study
        assessed the influence of a daily bolus of protein prior to sleep on performance adaptations,
        body composition and recovery in British Army recruits.
  Dietary protein is crucial for optimising physical training adaptations such as muscular
        strength and mass, which are key aims for athletic populations, including British Army
        recruits. New recruits fail to meet the recommended protein intake during basic training
        (BT), with negligible amounts consumed in the evening. This study aimed to assess the
        influence of a daily bolus of protein prior to sleep on performance adaptations, body
        composition and recovery in British Army recruits. The study will recruit a mixed cohort of
        >120 new recruits from the United Kingdom (UK) British Army who will be randomised into a
        dietary control (CON), carbohydrate placebo (PLA), moderate (20g) protein (MOD) or high (60g)
        protein (HIGH) supplementation group. Supplements will be isocaloric and consumed daily on
        weekday evenings between 2000 and 2100h for 10 weeks during BT, alongside standardised
        dietary intake and BT activities. Performance tests (mid-thigh pull, medicine ball throw, 2km
        run time, maximal push-up and maximal vertical jump) and body composition will be assessed at
        the start and end of BT under standardised conditions. Dietary intake, energy expenditure,
        salivary hormones, urinary nitrogen balance, perceived muscle soreness, rating of perceived
        exertion, mood and fatigue will be assessed at the start, middle and end of BT. The
        underlying aim of this study is to assess whether inclusion of nocturnal protein
        supplementation will influence performance adaptations, body composition changes or acute
        recovery in British Army recruits.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Participant)
  measure: Lower body strength performance
  time frame: 12 weeks
  description: Mid-thigh pull
  measure: Body composition
  time frame: 12 weeks
  description: Fat-free mass
  arm group label: High protein intake supplementation
  arm group type: Experimental
  description: A daily 60g dose of whey protein supplementation received between 8-9pm during BT.
  arm group label: Moderate protein intake supplementation
  arm group type: Experimental
  description: A daily 20g dose of whey protein supplementation received between 8-9pm during BT.
  arm group label: Carbohydrate placebo supplementation
  arm group type: Placebo Comparator
  description: A daily isocaloric carbohydrate (maltodextrin) placebo received between 8-9pm during BT.
  arm group label: Control group
  arm group type: Other
  description: Control group, no daily supplement received, only participating in BT.
  intervention type: Dietary Supplement
  intervention name: High protein supplement
  description: The participants received a 60g protein bolus each evening prior to sleep from week 3 to week 12 of training.
  arm group label: High protein intake supplementation
  intervention type: Dietary Supplement
  intervention name: Moderate protein supplement
  description: The participants received a 20g protein bolus each evening prior to sleep from week 3 to week 12 of training.
  arm group label: Moderate protein intake supplementation
  intervention type: Dietary Supplement
  intervention name: Carbohydrate placebo
  description: The participants received an isocaloric carbohydrate bolus each evening prior to sleep from week 3 to week 12 of training.
  arm group label: Carbohydrate placebo supplementation
  intervention type: Other
  intervention name: Control: No supplementation
  description: The participants did not receive any supplementation but instead acted as a control group doing BT only
  arm group label: Control group
  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: Body Weight
  sharing ipd: No