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/NCT05971147</url>
    </required_header>
    <id_info>
      <org_study_id>6037330</org_study_id>
      <nct_id>NCT05971147</nct_id>
    </id_info>
    <brief_title>Time Course Change in Skeletal Muscle and Blood Phospholipid Composition With Omega-3 Fatty Acid Supplementation</brief_title>
    <official_title>Time Course Change in Skeletal Muscle and Blood Phospholipid Composition With Omega-3 Fatty Acid Supplementation and Washout in Adult Women and Men</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Queen's University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Queen's 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>
        Increased omega-3 fatty acid composition of human skeletal muscle phospholipids is linked to&#xD;
        improved skeletal muscle strength and growth in women and men. However, what is unknown is if&#xD;
        biological sex influences skeletal muscle phospholipid composition in response to omega-3&#xD;
        fatty acid supplementation. Moreover, whilst time course changes in skeletal muscle&#xD;
        phospholipid composition with omega-3 fatty acid intake have been established, no study has&#xD;
        characterized a washout of omega-3 fatty acids from skeletal muscle phospholipids following&#xD;
        cessation of omega-3 fatty acid intake. Thus, the aim of the present investigation is to&#xD;
        establish a time course change and washout of omega-3 fatty acids from skeletal muscle&#xD;
        phospholipids in response to omega-3 fatty acid intake. The investigators also aim to&#xD;
        establish if this washout is impacted by biological sex.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Previous work has shown that supplementing with omega-3 fatty acids leads to increased&#xD;
        omega-3 fatty acid composition of skeletal muscle phospholipids. This increase in skeletal&#xD;
        muscle omega-3 fatty acid phospholipid composition following omega-3 fatty acid intake is&#xD;
        linked to potentiated rates of skeletal muscle protein synthesis in response to amino acid&#xD;
        and insulin infusion in older and younger women and men. Supplementation with omega-3 fatty&#xD;
        acids is also known to enhance skeletal muscle strength and size in older adults. The exact&#xD;
        biological mechanisms responsible for the anabolic influence of omega-3 fatty acid are&#xD;
        unknown. However, there is emerging data that acid (EPA) and docosahexaenoic acid (DHA) play&#xD;
        an active role. Indeed, there is now a growing body of evidence in cells, preclinical models,&#xD;
        and humans that these key omega-3 fatty acids are primarily responsible for the observed&#xD;
        anabolic impact of omega-3 fatty acids supplement intake towards skeletal muscle.&#xD;
  &#xD;
        Whilst there is a growing body of literature supporting the anabolic potential of EPA and DHA&#xD;
        in skeletal muscle, few studies have examined how biological sex influences EPA and DHA&#xD;
        incorporation into skeletal muscle. Indeed, it has been purported that women EPA to DHA more&#xD;
        efficiently in blood erythrocytes compared to men. To the investigators knowledge, no study&#xD;
        examined how biological sex impacts changes in skeletal muscle phospholipid profiles in&#xD;
        response to EPA and DHA intake. Moreover, no study has established a time course washout of&#xD;
        EPA and DHA from skeletal muscle phospholipids in response to the cessation of EPA and DHA&#xD;
        intake. The lack of data regarding EPA and DHA washout from skeletal muscle in response to&#xD;
        EPA and DHA intake limits the ability to execute within subject cross over trials, which is&#xD;
        important given that within-subject cross over trials possess more statistical power than&#xD;
        parallel arm trials. Thus, establishing a washout of EPA and DHA from skeletal muscle&#xD;
        phospholipids in response to EPA and DHA intake would provide important information for the&#xD;
        design of future trials in this field.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Single-arm 5g per day of omega-3 fatty acid intake (3750 mg EPA and 1250 mg DHA)</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>All participants will take part in the same intervention, which will be fully disclosed to each participant.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in skeletal muscle EPA and DHA content</measure>
      <time_frame>At 0, 6, 8, 16, 20, and 22 weeks.</time_frame>
      <description>Skeletal muscle phospholipid composition will be assessed at all time points by means of gas chromatography</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in erythrocyte EPA and DHA content</measure>
      <time_frame>0, 6, 8, 16, 20, and 22 weeks.</time_frame>
      <description>Erythrocyte phospholipid composition will be assessed at all time points by means of gas chromatography</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in the expression of mitochondrial related proteins</measure>
      <time_frame>0, 6, 8, 16, 20, and 22 weeks.</time_frame>
      <description>Mitochondrial proteins involved in oxidative phosphorylation (e.g. ANT1) will be assessed by means of western blotting at all time points.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in the expression of translational factors related to skeletal muscle protein synthesis</measure>
      <time_frame>0, 6, 8, 16, 20, and 22 weeks.</time_frame>
      <description>Translational factors involved in skeletal muscle protein synthesis (e.g. p70S6K1) will be assessed by means of western blotting at all time points.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in circulating glucose concentrations</measure>
      <time_frame>0, 6, 8, 16, 20, and 22 weeks.</time_frame>
      <description>Glucose concentrations will be assessed by ELISA at all time points.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in circulating insulin concentrations</measure>
      <time_frame>0, 6, 8, 16, 20, and 22 weeks.</time_frame>
      <description>Insulin concentrations will be assessed by ELISA at all time points.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in circulating TNFa concentrations</measure>
      <time_frame>0, 6, 8, 16, 20, and 22 weeks.</time_frame>
      <description>TNFa concentrations will be assessed by ELISA at all time points.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in circulating CRP concentrations</measure>
      <time_frame>0, 6, 8, 16, 20, and 22 weeks.</time_frame>
      <description>CRP concentrations will be assessed by ELISA at all time points.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">28</enrollment>
    <condition>Skeletal Muscle Fatty Acid Metabolism</condition>
    <arm_group>
      <arm_group_label>Fish Oil Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participants will be placed in this group</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Fish oil</intervention_name>
      <description>Participants in this group will receive 5g fish oil with high EPA and DHA content per day</description>
      <arm_group_label>Fish Oil Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Males and females 19-30 years&#xD;
  &#xD;
            -  BMI between 18-29 kg/m2&#xD;
  &#xD;
            -  Free of musculoskeletal injuries&#xD;
  &#xD;
            -  Participants not currently pregnant&#xD;
  &#xD;
            -  Participants willing to maintain current use of contraceptives or post-menopausal&#xD;
               supplementation if any for the duration of the study.&#xD;
  &#xD;
            -  Not allergic to fish&#xD;
  &#xD;
            -  COVID-19 vaccinated to comply with Queen's University's return to campus guidelines,&#xD;
               unless exempt by reasons from the Ontario Human Rights Code&#xD;
  &#xD;
            -  Recreationally active&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any muscular, neurological, respiratory or metabolic disease including diabetes&#xD;
  &#xD;
            -  Any form of cancer currently or in the last 5 years&#xD;
  &#xD;
            -  Currently taking fish oil supplements&#xD;
  &#xD;
            -  Currently taking any form of steroid&#xD;
  &#xD;
            -  Consuming &gt;2 oily fish meals per week&#xD;
  &#xD;
            -  Pregnant&#xD;
  &#xD;
            -  Any current illness&#xD;
  &#xD;
            -  Any current/past lower limb injury/surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Chris McGlory, PhD</last_name>
      <phone>6135336000</phone>
      <phone_ext>75410</phone_ext>
      <email>chris.mcglory@queensu.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>School of Kinesiology and Health Studies</name>
        <address>
          <city>Kingston</city>
          <state>Ontario</state>
          <zip>K7L 3N6</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Chris McGlory, PhD</last_name>
        <phone>6135336000</phone>
        <phone_ext>75410</phone_ext>
        <email>chris.mcglory@queensu.ca</email>
      </contact>
      <contact_backup>
        <last_name>Sydney Smart, BSc</last_name>
        <email>sydney.smart@queensu.ca</email>
      </contact_backup>
      <investigator>
        <last_name>Chris McGlory, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 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>Queen's University</investigator_affiliation>
      <investigator_full_name>Dr. Chris McGlory, PhD</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Omega-3 fatty acids</keyword>
    <keyword>Eicosapentaenoic acid</keyword>
    <keyword>Docosahexaenoic acid</keyword>
    <keyword>Fish oil</keyword>
    <keyword>Skeletal muscle</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data will be retained by the investigators, and shared under reasonable request.</ipd_description>
    </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/NCT05971147
  org study id: 6037330
  nct id: NCT05971147
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Increased omega-3 fatty acid composition of human skeletal muscle phospholipids is linked to
        improved skeletal muscle strength and growth in women and men. However, what is unknown is if
        biological sex influences skeletal muscle phospholipid composition in response to omega-3
        fatty acid supplementation. Moreover, whilst time course changes in skeletal muscle
        phospholipid composition with omega-3 fatty acid intake have been established, no study has
        characterized a washout of omega-3 fatty acids from skeletal muscle phospholipids following
        cessation of omega-3 fatty acid intake. Thus, the aim of the present investigation is to
        establish a time course change and washout of omega-3 fatty acids from skeletal muscle
        phospholipids in response to omega-3 fatty acid intake. The investigators also aim to
        establish if this washout is impacted by biological sex.
  Previous work has shown that supplementing with omega-3 fatty acids leads to increased
        omega-3 fatty acid composition of skeletal muscle phospholipids. This increase in skeletal
        muscle omega-3 fatty acid phospholipid composition following omega-3 fatty acid intake is
        linked to potentiated rates of skeletal muscle protein synthesis in response to amino acid
        and insulin infusion in older and younger women and men. Supplementation with omega-3 fatty
        acids is also known to enhance skeletal muscle strength and size in older adults. The exact
        biological mechanisms responsible for the anabolic influence of omega-3 fatty acid are
        unknown. However, there is emerging data that acid (EPA) and docosahexaenoic acid (DHA) play
        an active role. Indeed, there is now a growing body of evidence in cells, preclinical models,
        and humans that these key omega-3 fatty acids are primarily responsible for the observed
        anabolic impact of omega-3 fatty acids supplement intake towards skeletal muscle.
  
        Whilst there is a growing body of literature supporting the anabolic potential of EPA and DHA
        in skeletal muscle, few studies have examined how biological sex influences EPA and DHA
        incorporation into skeletal muscle. Indeed, it has been purported that women EPA to DHA more
        efficiently in blood erythrocytes compared to men. To the investigators knowledge, no study
        examined how biological sex impacts changes in skeletal muscle phospholipid profiles in
        response to EPA and DHA intake. Moreover, no study has established a time course washout of
        EPA and DHA from skeletal muscle phospholipids in response to the cessation of EPA and DHA
        intake. The lack of data regarding EPA and DHA washout from skeletal muscle in response to
        EPA and DHA intake limits the ability to execute within subject cross over trials, which is
        important given that within-subject cross over trials possess more statistical power than
        parallel arm trials. Thus, establishing a washout of EPA and DHA from skeletal muscle
        phospholipids in response to EPA and DHA intake would provide important information for the
        design of future trials in this field.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single-arm 5g per day of omega-3 fatty acid intake (3750 mg EPA and 1250 mg DHA)
  primary purpose: Basic Science
  masking: None (Open Label)
  masking description: All participants will take part in the same intervention, which will be fully disclosed to each participant.
  measure: Changes in skeletal muscle EPA and DHA content
  time frame: At 0, 6, 8, 16, 20, and 22 weeks.
  description: Skeletal muscle phospholipid composition will be assessed at all time points by means of gas chromatography
  measure: Changes in erythrocyte EPA and DHA content
  time frame: 0, 6, 8, 16, 20, and 22 weeks.
  description: Erythrocyte phospholipid composition will be assessed at all time points by means of gas chromatography
  measure: Changes in the expression of mitochondrial related proteins
  time frame: 0, 6, 8, 16, 20, and 22 weeks.
  description: Mitochondrial proteins involved in oxidative phosphorylation (e.g. ANT1) will be assessed by means of western blotting at all time points.
  measure: Changes in the expression of translational factors related to skeletal muscle protein synthesis
  time frame: 0, 6, 8, 16, 20, and 22 weeks.
  description: Translational factors involved in skeletal muscle protein synthesis (e.g. p70S6K1) will be assessed by means of western blotting at all time points.
  measure: Changes in circulating glucose concentrations
  time frame: 0, 6, 8, 16, 20, and 22 weeks.
  description: Glucose concentrations will be assessed by ELISA at all time points.
  measure: Changes in circulating insulin concentrations
  time frame: 0, 6, 8, 16, 20, and 22 weeks.
  description: Insulin concentrations will be assessed by ELISA at all time points.
  measure: Changes in circulating TNFa concentrations
  time frame: 0, 6, 8, 16, 20, and 22 weeks.
  description: TNFa concentrations will be assessed by ELISA at all time points.
  measure: Changes in circulating CRP concentrations
  time frame: 0, 6, 8, 16, 20, and 22 weeks.
  description: CRP concentrations will be assessed by ELISA at all time points.
  arm group label: Fish Oil Group
  arm group type: Experimental
  description: All participants will be placed in this group
  intervention type: Dietary Supplement
  intervention name: Fish oil
  description: Participants in this group will receive 5g fish oil with high EPA and DHA content per day
  arm group label: Fish Oil Group
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Chris McGlory, PhD
  phone: 6135336000
  phone ext: 75410
  email: chris.mcglory@queensu.ca
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: Queen's University
  investigator full name: Dr. Chris McGlory, PhD
  investigator title: Assistant Professor
  sharing ipd: No
  ipd description: Data will be retained by the investigators, and shared under reasonable request.