<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/NCT02204709</url>
  </required_header>
  <id_info>
    <org_study_id>GFHNRC029</org_study_id>
    <nct_id>NCT02204709</nct_id>
  </id_info>
  <brief_title>Disease Risk Reduction and Omega-3 Rich Rainbow Trout (Fish for Health)</brief_title>
  <official_title>Disease Risk Reduction and n-3 Rich Rainbow Trout (Fish for Health)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>USDA Grand Forks Human Nutrition Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>USDA Grand Forks Human Nutrition Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine how eating fish raised to have different levels of&#xD;
      omega-3 fatty acids will reduce cardiovascular risk markers in people with elevated&#xD;
      cardiovascular risk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Consumption of fish high in long chain omega-3 fatty acids (LCn3) is associated with&#xD;
      reduction of cardiovascular disease (CVD) risk. CVD is a major cause of death in the United&#xD;
      States. The current obesity epidemic contributes significantly to elevated CVD risk by&#xD;
      increasing inflammation and platelet dysfunction. Prevention of CVD is a public health goal&#xD;
      and comprises several avenues of action, of which inclusion of LCn3-rich fish in the diet may&#xD;
      be one of the most effective.&#xD;
&#xD;
      Obese participants will participate in a double blind, randomized, cross-over designed trial&#xD;
      in which they will consume twice-weekly a prepared meal containing diploid (2N) farmed&#xD;
      rainbow trout, triploid (3N) farmed rainbow trout containing higher levels of LCn3, or&#xD;
      tilapia, a low LCn3 fish.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID-19 pandemic &amp; expiration of grant funds&#xD;
  </why_stopped>
  <start_date type="Actual">June 2015</start_date>
  <completion_date type="Actual">March 25, 2020</completion_date>
  <primary_completion_date type="Actual">March 25, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in platelet activation at week 6 of each treatment</measure>
    <time_frame>Baseline, Week 6</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in plasma interleukin-6 (IL-6) at week 6 of each treatment</measure>
    <time_frame>Baseline, Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in plasma tumor necrosis factor alpha (TNFa) at week 6 of each treatment</measure>
    <time_frame>Baseline, Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in urinary prostaglandin E2 (PGE2) at week 6 of each treatment</measure>
    <time_frame>Baseline, Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in urinary thromboxane B2 (TxB2-M) at week 6 of each treatment</measure>
    <time_frame>Baseline, Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in urinary prostaglandin I2 (PGI2-M) at week 6 of each treatment</measure>
    <time_frame>Baseline, Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in serum thromboxane B2 (TxB2) at week 6 of each treatment</measure>
    <time_frame>Baseline, Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in plasma phospholipid fatty acids at week 6 of each treatment</measure>
    <time_frame>Baseline, Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in platelet fatty acids at week 6 of each treatment</measure>
    <time_frame>Baseline, Week 6</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Diploid Trout entrees</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will consume a 200 gram portion of 2N trout (diploid; two sets of chromosomes) twice weekly in a prepared meal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triploid Trout entrees</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will consume a 200 gram portion of 3N trout (triploid; three sets of chromosomes) twice weekly in a prepared meal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tilapia entrees</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will consume a 200 gram portion of tilapia twice weekly in a prepared meal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>2N Trout</intervention_name>
    <description>Diploid/2N trout source</description>
    <arm_group_label>Diploid Trout entrees</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>3N Trout</intervention_name>
    <description>Triploid/3N trout source</description>
    <arm_group_label>Triploid Trout entrees</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tilapia</intervention_name>
    <description>Tilapia/control fish source</description>
    <arm_group_label>Tilapia entrees</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI of 30 - 39.9 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are allergic to fish&#xD;
&#xD;
          -  Use tobacco products or nicotine in any form including snuff, pills, and patches, or&#xD;
             e-cigarettes in the past 6 months&#xD;
&#xD;
          -  Have established cardiovascular, pulmonary, and/or a metabolic disease such as&#xD;
             diabetes&#xD;
&#xD;
          -  Have uncontrolled high blood pressure&#xD;
&#xD;
          -  Have alcohol, anabolic steroids, or other substance abuse issues&#xD;
&#xD;
          -  Consume more than 3 alcoholic drinks/week&#xD;
&#xD;
          -  Have cancer&#xD;
&#xD;
          -  Are pregnant or nursing&#xD;
&#xD;
          -  Take non-steroidal anti-inflammatory drugs such as aspirin, ibuprofen or Aleve, lipid&#xD;
             modifying drugs such as statins, take medications for blood glucose such as insulin or&#xD;
             metformin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Picklo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>USDA Grand Forks Human Nutrition Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USDA Grand Forks Human Nutrition Research Center</name>
      <address>
        <city>Grand Forks</city>
        <state>North Dakota</state>
        <zip>58203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/</url>
    <description>Grand Forks Human Nutrition Research Center Current Nutrition Studies</description>
  </link>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obese</keyword>
  <keyword>omega-3 fatty acids</keyword>
  <keyword>fish</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 7, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT02204709/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02204709
org study id: GFHNRC029
nct id: NCT02204709
lead sponsor: 
has dmc: No
The purpose of this study is to determine how eating fish raised to have different levels of
      omega-3 fatty acids will reduce cardiovascular risk markers in people with elevated
      cardiovascular risk.
Consumption of fish high in long chain omega-3 fatty acids (LCn3) is associated with
      reduction of cardiovascular disease (CVD) risk. CVD is a major cause of death in the United
      States. The current obesity epidemic contributes significantly to elevated CVD risk by
      increasing inflammation and platelet dysfunction. Prevention of CVD is a public health goal
      and comprises several avenues of action, of which inclusion of LCn3-rich fish in the diet may
      be one of the most effective.

      Obese participants will participate in a double blind, randomized, cross-over designed trial
      in which they will consume twice-weekly a prepared meal containing diploid (2N) farmed
      rainbow trout, triploid (3N) farmed rainbow trout containing higher levels of LCn3, or
      tilapia, a low LCn3 fish.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Change from baseline in platelet activation at week 6 of each treatment
time frame: Baseline, Week 6
measure: Change from baseline in plasma interleukin-6 (IL-6) at week 6 of each treatment
time frame: Baseline, Week 6
measure: Change from baseline in plasma tumor necrosis factor alpha (TNFa) at week 6 of each treatment
time frame: Baseline, Week 6
measure: Change from baseline in urinary prostaglandin E2 (PGE2) at week 6 of each treatment
time frame: Baseline, Week 6
measure: Change from baseline in urinary thromboxane B2 (TxB2-M) at week 6 of each treatment
time frame: Baseline, Week 6
measure: Change from baseline in urinary prostaglandin I2 (PGI2-M) at week 6 of each treatment
time frame: Baseline, Week 6
measure: Change from baseline in serum thromboxane B2 (TxB2) at week 6 of each treatment
time frame: Baseline, Week 6
measure: Change from baseline in plasma phospholipid fatty acids at week 6 of each treatment
time frame: Baseline, Week 6
measure: Change from baseline in platelet fatty acids at week 6 of each treatment
time frame: Baseline, Week 6
arm group label: Diploid Trout entrees
arm group type: Experimental
description: Subjects will consume a 200 gram portion of 2N trout (diploid; two sets of chromosomes) twice weekly in a prepared meal.
arm group label: Triploid Trout entrees
arm group type: Experimental
description: Subjects will consume a 200 gram portion of 3N trout (triploid; three sets of chromosomes) twice weekly in a prepared meal.
arm group label: Tilapia entrees
arm group type: Experimental
description: Subjects will consume a 200 gram portion of tilapia twice weekly in a prepared meal.
intervention type: Other
intervention name: 2N Trout
description: Diploid/2N trout source
arm group label: Diploid Trout entrees
intervention type: Other
intervention name: 3N Trout
description: Triploid/3N trout source
arm group label: Triploid Trout entrees
intervention type: Other
intervention name: Tilapia
description: Tilapia/control fish source
arm group label: Tilapia entrees
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matthew Picklo, PhD
role: Principal Investigator
affiliation: USDA Grand Forks Human Nutrition Research Center
facility: 
country: United States
url: https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/
description: Grand Forks Human Nutrition Research Center Current Nutrition Studies
responsible party type: Sponsor
sharing ipd: No
provided document: 