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/NCT06005064</url>
    </required_header>
    <id_info>
      <org_study_id>MASK</org_study_id>
      <nct_id>NCT06005064</nct_id>
    </id_info>
    <brief_title>Middle Age muScle Krill Study</brief_title>
    <acronym>MASK</acronym>
    <official_title>The Effect of Krill Oil Supplementation on Muscle Function and Mass in Middle-aged Adults: A Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Glasgow</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Glasgow</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>
        This study will determine the effect of 6 months of supplementation with krill oil on muscle&#xD;
        strength and mass in middle-aged adults. The study hypothesis is that krill oil&#xD;
        supplementation will increase muscle strength and mass in middle-aged adults.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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>
      <intervention_model_description>1:1 basis</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>Supplements will be identical in look and taste</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in knee extensor maximal isometric torque ( MVC)</measure>
      <time_frame>Change from baseline to 24 weeks</time_frame>
      <description>Knee extensor maximal isometric torque measured during a maximal voluntary contraction</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in fat mass</measure>
      <time_frame>Change from baseline to 24 weeks</time_frame>
      <description>Whole body fat mass measured by measured via bio-electrical impedance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in lean mass</measure>
      <time_frame>Change from baseline to 24 weeks</time_frame>
      <description>Whole body lean mass measured by measured via bio-electrical impedance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in omega-3 levels</measure>
      <time_frame>Change from baseline to 24 weeks</time_frame>
      <description>Red blood cell omega-3 levels</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Grip strength</measure>
      <time_frame>Change from baseline to 24 weeks</time_frame>
      <description>Grip strength measured with a hand held dynamometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Muscle thickness</measure>
      <time_frame>Change from baseline to 24 weeks</time_frame>
      <description>Vastus lateralis muscle thickness measured by ultrasound</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in systemic inflammation</measure>
      <time_frame>Change from baseline to 24 weeks</time_frame>
      <description>Plasma levels of C-reactive protein, IL-1, IL-6, IL-8, IL-10, and TNF-α</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in muscle inflammation</measure>
      <time_frame>Change from baseline to 24 weeks</time_frame>
      <description>Muscle total protein levels of TNF-α, IL-1β, IL-6, IL-8, MCP-1 and total and phosphorylated levels of NFκB, JNK1/2 and STAT3</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in muscle anabolic signalling</measure>
      <time_frame>Change from baseline to 24 weeks</time_frame>
      <description>Muscle total and phosphorylated protein levels of mTOR, IRS-1, Akt, 4EBP-1, p70S6K, RPS6, FOXO-1, GSK3β and total protein levels of MAFBx and MURF-1</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">92</enrollment>
    <condition>Sarcopenia</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Krill oil 4g/day for 24 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Vegetable oil 4g/day for 24 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Krill oil</intervention_name>
      <description>Superba krill oil</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Vegetable oil</intervention_name>
      <description>Mixed vegetable oil</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be 35-60 years old&#xD;
  &#xD;
            -  Have a BMI of less than 35kg/m2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  People with diabetes, severe cardiovascular disease, seizure disorders, uncontrolled&#xD;
               hypertension (&gt;150/90mmHg at baseline measurement), cancer or cancer that has been in&#xD;
               remission &lt;5 years, ambulatory impairments which would limit the ability to perform&#xD;
               assessments of muscle function, dementia, on anticoagulant therapy, and/or taking&#xD;
               medication known to affect muscle (e.g., steroids).&#xD;
  &#xD;
            -  People who have allergies to seafood, and/or regular consumption of more than 1&#xD;
               portion of oily fish per week.&#xD;
  &#xD;
            -  People who perform regular (&gt;1 day/week) resistance exercise training.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University of Glasgow</name>
        <address>
          <city>Glasgow</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Stuart Gray, PhD</last_name>
        <phone>01413302569</phone>
        <email>stuart.gray@glasgow.ac.uk</email>
      </contact>
      <investigator>
        <last_name>Stuart Gray, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Glasgow</investigator_affiliation>
      <investigator_full_name>Stuart Gray</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Krill oil</keyword>
    <keyword>Muscle strength</keyword>
    <keyword>Muscle mass</keyword>
    <keyword>Middle-aged</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sarcopenia</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/NCT06005064
  org study id: MASK
  nct id: NCT06005064
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will determine the effect of 6 months of supplementation with krill oil on muscle
        strength and mass in middle-aged adults. The study hypothesis is that krill oil
        supplementation will increase muscle strength and mass in middle-aged adults.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 1:1 basis
  primary purpose: Prevention
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: Supplements will be identical in look and taste
  measure: Change in knee extensor maximal isometric torque ( MVC)
  time frame: Change from baseline to 24 weeks
  description: Knee extensor maximal isometric torque measured during a maximal voluntary contraction
  measure: Change in fat mass
  time frame: Change from baseline to 24 weeks
  description: Whole body fat mass measured by measured via bio-electrical impedance
  measure: Change in lean mass
  time frame: Change from baseline to 24 weeks
  description: Whole body lean mass measured by measured via bio-electrical impedance
  measure: Change in omega-3 levels
  time frame: Change from baseline to 24 weeks
  description: Red blood cell omega-3 levels
  measure: Change in Grip strength
  time frame: Change from baseline to 24 weeks
  description: Grip strength measured with a hand held dynamometer
  measure: Change in Muscle thickness
  time frame: Change from baseline to 24 weeks
  description: Vastus lateralis muscle thickness measured by ultrasound
  measure: Change in systemic inflammation
  time frame: Change from baseline to 24 weeks
  description: Plasma levels of C-reactive protein, IL-1, IL-6, IL-8, IL-10, and TNF-α
  measure: Change in muscle inflammation
  time frame: Change from baseline to 24 weeks
  description: Muscle total protein levels of TNF-α, IL-1β, IL-6, IL-8, MCP-1 and total and phosphorylated levels of NFκB, JNK1/2 and STAT3
  measure: Change in muscle anabolic signalling
  time frame: Change from baseline to 24 weeks
  description: Muscle total and phosphorylated protein levels of mTOR, IRS-1, Akt, 4EBP-1, p70S6K, RPS6, FOXO-1, GSK3β and total protein levels of MAFBx and MURF-1
  arm group label: Intervention
  arm group type: Experimental
  description: Krill oil 4g/day for 24 weeks
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Vegetable oil 4g/day for 24 weeks
  intervention type: Dietary Supplement
  intervention name: Krill oil
  description: Superba krill oil
  arm group label: Intervention
  intervention type: Dietary Supplement
  intervention name: Vegetable oil
  description: Mixed vegetable oil
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  contact: 
  investigator: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: University of Glasgow
  investigator full name: Stuart Gray
  investigator title: Professor
  mesh term: Sarcopenia
  sharing ipd: No