<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/NCT03259412</url>
  </required_header>
  <id_info>
    <org_study_id>LoughboroughU</org_study_id>
    <nct_id>NCT03259412</nct_id>
  </id_info>
  <brief_title>Effect of Combined Fatty Acid Supplementation and Eccentric Exercise Training on Exercise Performance</brief_title>
  <acronym>FAT</acronym>
  <official_title>Effect of Combined Fatty Acid Supplementation and Eccentric Exercise Training on Exercise Performance, Inflammation, Gene Expression and Epigenetic Signatures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loughborough University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loughborough 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>
      The aim of the study is to determine whether fish oil (specifically omega-3 long chain&#xD;
      polyunsaturated fatty acids [EPA-DHA]) supplementation can enhance eccentric resistance&#xD;
      exercise performance when combined with a resistance exercise training study. The&#xD;
      investigators aim to establish the potential mechanisms that might mediate performance&#xD;
      changes at a cellular level.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">December 20, 2017</completion_date>
  <primary_completion_date type="Actual">December 20, 2017</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>Strength</measure>
    <time_frame>Change from baseline strength at 11 weeks</time_frame>
    <description>Quadriceps and Hamstring strength using an isokinetic dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Leg power</measure>
    <time_frame>Change from baseline strength at 11 weeks</time_frame>
    <description>Dynamic leg power assessed through jump height on force platform</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Exercise-induced Inflammation</condition>
  <arm_group>
    <arm_group_label>Fish Oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fish oil 5.1g/ day - Premium Omega-3, Norwegian Pure-3, Oslo, Norway</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Olive Oil 6g/ day - Premium Omega-3, Norwegian Pure-3, Oslo, Norway</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fish Oil</intervention_name>
    <description>Fish Oil Capsule</description>
    <arm_group_label>Fish Oil</arm_group_label>
    <other_name>n-3 PUFA, Omega-3</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Olive Oil capsule manufactured to mimic fish oil capsule</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Olive Oil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Resistance exercise training within the past 6 months&#xD;
&#xD;
          -  Vitamin or fish oil supplementation over the past 6 months&#xD;
&#xD;
          -  Habitual use of anti-inflammatory drugs&#xD;
&#xD;
          -  History of heart disease&#xD;
&#xD;
          -  History of coagulation/bleeding disorder&#xD;
&#xD;
          -  History of metabolic disease&#xD;
&#xD;
          -  Serious allergy&#xD;
&#xD;
          -  Known to have blood-borne virus&#xD;
&#xD;
          -  Females (Due to differences in cell membrane incorporation of Omega-3 between the&#xD;
             sexes and the testing schedule being unable to fit in with menstrual cycle, altering&#xD;
             the blood markers that are being measured)&#xD;
&#xD;
          -  Currently no symptoms of general illness&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lynsey S Wilson, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loughborough University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loughborough University</name>
      <address>
        <city>Leicester</city>
        <zip>LE11 3TU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>March 26, 2018</last_update_submitted>
  <last_update_submitted_qc>March 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Loughborough University</investigator_affiliation>
    <investigator_full_name>Lynsey Wilson</investigator_full_name>
    <investigator_title>Technical Tutor in Exercise Physiology/ PhD Student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</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/NCT03259412
org study id: LoughboroughU
nct id: NCT03259412
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to determine whether fish oil (specifically omega-3 long chain
      polyunsaturated fatty acids [EPA-DHA]) supplementation can enhance eccentric resistance
      exercise performance when combined with a resistance exercise training study. The
      investigators aim to establish the potential mechanisms that might mediate performance
      changes at a cellular level.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Strength
time frame: Change from baseline strength at 11 weeks
description: Quadriceps and Hamstring strength using an isokinetic dynamometer
measure: Leg power
time frame: Change from baseline strength at 11 weeks
description: Dynamic leg power assessed through jump height on force platform
arm group label: Fish Oil
arm group type: Experimental
description: Fish oil 5.1g/ day - Premium Omega-3, Norwegian Pure-3, Oslo, Norway
arm group label: Placebo
arm group type: Placebo Comparator
description: Olive Oil 6g/ day - Premium Omega-3, Norwegian Pure-3, Oslo, Norway
intervention type: Dietary Supplement
intervention name: Fish Oil
description: Fish Oil Capsule
arm group label: Fish Oil
other name: n-3 PUFA, Omega-3
intervention type: Dietary Supplement
intervention name: Placebo
description: Olive Oil capsule manufactured to mimic fish oil capsule
arm group label: Placebo
other name: Olive Oil
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lynsey S Wilson, MSc
role: Principal Investigator
affiliation: Loughborough University
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Loughborough University
investigator full name: Lynsey Wilson
investigator title: Technical Tutor in Exercise Physiology/ PhD Student
mesh term: Inflammation
sharing ipd: No