<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/NCT01666392</url>
  </required_header>
  <id_info>
    <org_study_id>#2232</org_study_id>
    <secondary_id>#2232</secondary_id>
    <nct_id>NCT01666392</nct_id>
  </id_info>
  <brief_title>Omega-3 Fatty Acid Supplementation in Older Adults</brief_title>
  <official_title>The Impact of Omega-3 Fatty Acid Supplementation on Markers of Inflammation and Lean Body Mass in Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Memphis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nordic Naturals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Memphis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study to determine whether Fish oil (Omega-3 Fatty Acid) supplementation&#xD;
      has an impact on inflammation and lean body mass in older adults. The investigators expect&#xD;
      that Fish oil supplementation will reduce inflammation and prevent the loss of lean mass&#xD;
      compared to placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">April 2013</completion_date>
  <primary_completion_date type="Anticipated">April 2013</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>C-Reactive protein</measure>
    <time_frame>At baseline testing and at 3 month endpoint</time_frame>
    <description>Inflammatory marker</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IL6</measure>
    <time_frame>At baseline and at 3 month endpoint</time_frame>
    <description>Inflammatory cytokine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TNFα</measure>
    <time_frame>At baseline and at 3 month endpoint</time_frame>
    <description>Inflammatory cytokine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skeletal muscle mass/body composition</measure>
    <time_frame>At baseline testing and at 3 month endpoint</time_frame>
    <description>The amount of skeletal muscle mass and fat mass and their ration will be determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower body muscular strength</measure>
    <time_frame>At baseline and at 3 month endpoint</time_frame>
    <description>Measurement of maximum strength in the leg press exercise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper body muscular strength</measure>
    <time_frame>At baseline and at 3 month endpoint</time_frame>
    <description>Measurement of maximum strength in the chest press exercise</description>
  </secondary_outcome>
  <other_outcome>
    <measure>EPA and DHA</measure>
    <time_frame>At baseline and at 3 month endpoint</time_frame>
    <description>To determine the effectiveness of fish oil supplementation, we measure EPA and DHA Omega-3 fatty acid levels</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Fish oil (Omega-3 fatty acid)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 capsules/day of ProOmega providing 650mg EPA and 450mg DHA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Soybean oil</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 capsules/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Omega-3 fatty acid</intervention_name>
    <description>Omega-3 fatty acid, Eicosapentaenoic acid+docosahexaenoic acid in capsule form</description>
    <arm_group_label>Fish oil (Omega-3 fatty acid)</arm_group_label>
    <other_name>ProOmega (Nordic Naturals)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Soybean oil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  60 years of age or over&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fish, seafood allergies, nut allergies, soy allergies&#xD;
&#xD;
          -  Habitual (&gt;1/week) fish or seafood consumption&#xD;
&#xD;
          -  Current Omega-3 supplement use&#xD;
&#xD;
          -  Gastrointestinal problems&#xD;
&#xD;
          -  Current anti-inflammatory medication use&#xD;
&#xD;
          -  Current anticoagulant medication use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zsolt Murlasits, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Memphis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Health and Sport Sciences, The University of Memphis</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38152</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>October 8, 2012</last_update_submitted>
  <last_update_submitted_qc>October 8, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Memphis</investigator_affiliation>
    <investigator_full_name>Zsolt Murlasits</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Omega-3 fatty acid</keyword>
  <keyword>Fish oil</keyword>
  <keyword>Muscle mass</keyword>
  <keyword>Muscle strength</keyword>
  <keyword>Older adults</keyword>
  <keyword>Circulating inflammatory cytokines</keyword>
  <keyword>Skeletal muscle mass</keyword>
  <keyword>Upper body strength</keyword>
  <keyword>Lower body strength</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <!-- 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/NCT01666392
org study id: #2232
secondary id: #2232
nct id: NCT01666392
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study to determine whether Fish oil (Omega-3 Fatty Acid) supplementation
      has an impact on inflammation and lean body mass in older adults. The investigators expect
      that Fish oil supplementation will reduce inflammation and prevent the loss of lean mass
      compared to placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: C-Reactive protein
time frame: At baseline testing and at 3 month endpoint
description: Inflammatory marker
measure: IL6
time frame: At baseline and at 3 month endpoint
description: Inflammatory cytokine
measure: TNFα
time frame: At baseline and at 3 month endpoint
description: Inflammatory cytokine
measure: Skeletal muscle mass/body composition
time frame: At baseline testing and at 3 month endpoint
description: The amount of skeletal muscle mass and fat mass and their ration will be determined.
measure: Lower body muscular strength
time frame: At baseline and at 3 month endpoint
description: Measurement of maximum strength in the leg press exercise
measure: Upper body muscular strength
time frame: At baseline and at 3 month endpoint
description: Measurement of maximum strength in the chest press exercise
measure: EPA and DHA
time frame: At baseline and at 3 month endpoint
description: To determine the effectiveness of fish oil supplementation, we measure EPA and DHA Omega-3 fatty acid levels
arm group label: Fish oil (Omega-3 fatty acid)
arm group type: Experimental
description: 2 capsules/day of ProOmega providing 650mg EPA and 450mg DHA
arm group label: Soybean oil
arm group type: Placebo Comparator
description: 2 capsules/day
intervention type: Dietary Supplement
intervention name: Omega-3 fatty acid
description: Omega-3 fatty acid, Eicosapentaenoic acid+docosahexaenoic acid in capsule form
arm group label: Fish oil (Omega-3 fatty acid)
other name: ProOmega (Nordic Naturals)
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo
arm group label: Soybean oil
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Zsolt Murlasits, Ph.D.
role: Principal Investigator
affiliation: The University of Memphis
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Memphis
investigator full name: Zsolt Murlasits
investigator title: Assistant Professor
mesh term: Inflammation