<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/NCT03808519</url>
  </required_header>
  <id_info>
    <org_study_id>HiREB 1932</org_study_id>
    <nct_id>NCT03808519</nct_id>
  </id_info>
  <brief_title>n3 PUFA and Muscle-disuse Atrophy in Older Women</brief_title>
  <official_title>Effects of n3 PUFA Supplementation on the Attenuation of Muscle Disuse Atrophy in Older Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster 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>
      This study will examine the influence of n3 PUFA supplementation on the rate of muscle&#xD;
      atrophy in older women undergoing 1 week of unilateral limb immobilization. Assessments in&#xD;
      skeletal muscle strength and skeletal muscle volume will also me made before, after and in&#xD;
      recovery from immobilization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Biological aging is associated with the loss of skeletal muscle mass and strength resulting&#xD;
      in compromised metabolic function and mobility. Throughout life, individuals will also&#xD;
      experience periods of reduced physical activity/muscle disuse that independently lower muscle&#xD;
      mass and strength accelerating the aging process. More importantly, older adults (especially&#xD;
      older women) that experience periods of muscle disuse are unable to recover muscle mass and&#xD;
      strength. The losses in muscle mass with aging and disuse are underpinned by feeding-induced&#xD;
      declines in rates of muscle protein synthesis. Thus, strategies to enhance muscle protein&#xD;
      synthesis could have clinical implications for those who wish to maintain metabolic health&#xD;
      and function during times of muscle disuse.&#xD;
&#xD;
      Supplementation with n3 PUFA-enriched fish oil has been shown to potentiate rates of muscle&#xD;
      protein synthesis in response to simulated feeding in both younger and older adults. Fish oil&#xD;
      supplementation also has been efficacious in enhancing skeletal muscle strength during a&#xD;
      period of resistance exercise training. A previous study from our group demonstrated that&#xD;
      younger women supplementing with n3 PUFA-enriched fish oil attenuated declines in skeletal&#xD;
      muscle mass and strength during 2 weeks of immobilization. However, no study has examined the&#xD;
      impact of fish oil supplementation to enhance muscle protein synthesis and offset declines in&#xD;
      muscle mass/strength during a period of immobilization in older women.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Anticipated">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle Cross-Sectional Area</measure>
    <time_frame>Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)</time_frame>
    <description>Changes in muscle cross-sectional area assessed by ultrasonography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Integrated rates of muscle protein synthesis</measure>
    <time_frame>pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)</time_frame>
    <description>Change in muscle protein synthesis using doubly labelled water (D2O)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skeletal muscle strength</measure>
    <time_frame>Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)</time_frame>
    <description>Change in skeletal muscle strength using the Biodex Dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial function</measure>
    <time_frame>Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)</time_frame>
    <description>Change in flow-mediated dilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular function</measure>
    <time_frame>Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)</time_frame>
    <description>Change in total femoral flow</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Muscle Atrophy</condition>
  <condition>Muscle Disuse Atrophy</condition>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>n3 PUFA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>n3 PUFA (3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Organic Sunflower Oil 5000mg per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>n3 PUFA-enriched fish oil</intervention_name>
    <description>3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day</description>
    <arm_group_label>n3 PUFA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Organic Sunflower Oil 5000mg per day</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Aged 55 - 75 years old&#xD;
&#xD;
          -  non-smoking (for at least 2 years)&#xD;
&#xD;
          -  &gt; 5 years post-menopausal&#xD;
&#xD;
          -  Body mass index (BMI) between 22 and 33 kg/m2&#xD;
&#xD;
          -  Mini-Mental State Exam (MMSE) score &gt; 20&#xD;
&#xD;
          -  Acceptable medications include: Angiotensin Converting Enzyme (ACE), Beta-Blockers,&#xD;
             Acetylsalicylic Acid, Calcium Channel blockers, Depression/Anxiety meds,&#xD;
             Bisphosphonates (Fosamax®, Didrocal®, Actonel®, Aclasta®).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of&#xD;
             the Investigators, would compromise the ability to comply with the study requirements.&#xD;
&#xD;
          -  History of cancer within the last 5 years, except basal cell carcinoma, non-squamous&#xD;
             skin carcinoma, prostate cancer, or carcinoma in situ with no significant progression&#xD;
             over the past 2 years.&#xD;
&#xD;
          -  Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease,&#xD;
             immune disorder, or metabolic/endocrine disorders or other disease that would preclude&#xD;
             oral n-3 PUFA supplement ingestion and/or assessment of safety and study objectives&#xD;
&#xD;
          -  Current illnesses which could interfere with the study (e.g. prolonged severe&#xD;
             diarrhea, regurgitation, difficulty swallowing)&#xD;
&#xD;
          -  Participation in a study of an investigational product less than 60 days or 5&#xD;
             half-lives of the investigational product, whichever is longer, before enrollment in&#xD;
             this study&#xD;
&#xD;
          -  Hypersensitivity to the test product&#xD;
&#xD;
          -  Excessive alcohol consumption (&gt;21 units/week)&#xD;
&#xD;
          -  Prior gastrointestinal bypass surgery&#xD;
&#xD;
          -  History of bleeding diathesis, platelet or coagulation disorders, or&#xD;
             antiplatelet/anticoagulation therapy&#xD;
&#xD;
          -  Personal or family history of clotting disorder or deep vein thrombosis&#xD;
&#xD;
          -  Concomitant use of corticosteroids, testosterone replacement therapy (ingestion,&#xD;
             injection, or transdermal), or any anabolic steroid&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>self- representation of gender identity</gender_description>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stuart M Phillips, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Exercise Metabolism Research Laboratory, McMaster Univeristy</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 4K1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>February 12, 2020</last_update_submitted>
  <last_update_submitted_qc>February 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Stuart Phillips</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>n3 PUFA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Disorders, Atrophic</mesh_term>
    <mesh_term>Sarcopenia</mesh_term>
    <mesh_term>Muscular Atrophy</mesh_term>
    <mesh_term>Atrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03808519
org study id: HiREB 1932
nct id: NCT03808519
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will examine the influence of n3 PUFA supplementation on the rate of muscle
      atrophy in older women undergoing 1 week of unilateral limb immobilization. Assessments in
      skeletal muscle strength and skeletal muscle volume will also me made before, after and in
      recovery from immobilization.
Biological aging is associated with the loss of skeletal muscle mass and strength resulting
      in compromised metabolic function and mobility. Throughout life, individuals will also
      experience periods of reduced physical activity/muscle disuse that independently lower muscle
      mass and strength accelerating the aging process. More importantly, older adults (especially
      older women) that experience periods of muscle disuse are unable to recover muscle mass and
      strength. The losses in muscle mass with aging and disuse are underpinned by feeding-induced
      declines in rates of muscle protein synthesis. Thus, strategies to enhance muscle protein
      synthesis could have clinical implications for those who wish to maintain metabolic health
      and function during times of muscle disuse.

      Supplementation with n3 PUFA-enriched fish oil has been shown to potentiate rates of muscle
      protein synthesis in response to simulated feeding in both younger and older adults. Fish oil
      supplementation also has been efficacious in enhancing skeletal muscle strength during a
      period of resistance exercise training. A previous study from our group demonstrated that
      younger women supplementing with n3 PUFA-enriched fish oil attenuated declines in skeletal
      muscle mass and strength during 2 weeks of immobilization. However, no study has examined the
      impact of fish oil supplementation to enhance muscle protein synthesis and offset declines in
      muscle mass/strength during a period of immobilization in older women.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Muscle Cross-Sectional Area
time frame: Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
description: Changes in muscle cross-sectional area assessed by ultrasonography
measure: Integrated rates of muscle protein synthesis
time frame: pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
description: Change in muscle protein synthesis using doubly labelled water (D2O)
measure: Skeletal muscle strength
time frame: Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
description: Change in skeletal muscle strength using the Biodex Dynamometer
measure: Endothelial function
time frame: Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
description: Change in flow-mediated dilation
measure: Vascular function
time frame: Baseline (-28 days), pre-immobilization (0 days), post-immobilization (7 days), recovery (21 days)
description: Change in total femoral flow
arm group label: n3 PUFA
arm group type: Experimental
description: n3 PUFA (3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day)
arm group label: Placebo
arm group type: Placebo Comparator
description: Organic Sunflower Oil 5000mg per day
intervention type: Dietary Supplement
intervention name: n3 PUFA-enriched fish oil
description: 3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day
arm group label: n3 PUFA
intervention type: Dietary Supplement
intervention name: Placebo
description: Organic Sunflower Oil 5000mg per day
arm group label: Placebo
criteria: 
gender: Female
gender based: Yes
gender description: self- representation of gender identity
minimum age: 55 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stuart M Phillips, PhD
role: Principal Investigator
affiliation: McMaster University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Stuart Phillips
investigator title: Professor
mesh term: Muscular Disorders, Atrophic
mesh term: Sarcopenia
mesh term: Muscular Atrophy
mesh term: Atrophy
sharing ipd: No