<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/NCT03043365</url>
  </required_header>
  <id_info>
    <org_study_id>170050</org_study_id>
    <secondary_id>17-H-0050</secondary_id>
    <nct_id>NCT03043365</nct_id>
  </id_info>
  <brief_title>Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults</brief_title>
  <official_title>Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Fish oils are known to be beneficial to health and believed to be cardio-protective. Omega-3&#xD;
      fatty acid is the most known fish oil available in the market. LCMUFA (long-chain&#xD;
      monounsaturated fatty acids) is also a fish oil but it is derived from fish that consumes a&#xD;
      diet rich in omega-11 fatty acid. Researchers want to study omega-11 fatty acid enriched fish&#xD;
      oil and understand its effect on cardiovascular health.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To understand the effects of LCMUFA from fish oil on cardiovascular health.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Healthy volunteers ages 18 and older with no history of cardiovascular disease&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with:&#xD;
&#xD;
        -  Medical history&#xD;
&#xD;
        -  Physical exam&#xD;
&#xD;
        -  Fasting blood and urine tests&#xD;
&#xD;
        -  Optional stool sample&#xD;
&#xD;
        -  Questions about their diet, exercise, and the types of medicines and dietary supplements&#xD;
           they take&#xD;
&#xD;
        -  7-day food diary&#xD;
&#xD;
        -  Cardio-Ankle Vascular Index (CAVI): Blood pressure is taken in the arms and legs. The&#xD;
           heart is monitored.&#xD;
&#xD;
        -  After the screening visit, participants will take 4 gel capsules, 3 times a day after&#xD;
           meals, for 8-10 weeks.&#xD;
&#xD;
        -  Electrocardiogram (EKG)&#xD;
&#xD;
      Participants will have 3 additional visits. All include repeats of the screening tests.&#xD;
&#xD;
      Visit 2 is 8 weeks after the screening visit. Participants will stop taking the capsules for&#xD;
      8 weeks after this visit.&#xD;
&#xD;
      Visit 3 is at least 16 weeks after starting the supplement. Participants will take 4&#xD;
      capsules, 3 times a day after meals, for 8 weeks after this visit.&#xD;
&#xD;
      Visit 4 is 8 weeks after starting the second supplement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Serum cholesterol is transported by lipoproteins, such as very low-density lipoprotein&#xD;
      (VLDL), low-density lipoproteins (LDL) and high-density lipoproteins (HDL), which vary in&#xD;
      their relationship to cardiovascular disease risk. LDL, for example, is proatherogenic,&#xD;
      whereas HDL is cardio-protective. Long-chain monounsaturated fatty acids (LCMUFA), fatty&#xD;
      acids over 18 carbons in length with a single double bond, have been shown in mice to&#xD;
      decrease proatherogenic lipoproteins, such as LDL, and reduce atherosclerosis. This study&#xD;
      will test the hypothesis that LCMUFA supplementation in humans will favorably alter the&#xD;
      lipoprotein lipid profile in regard to cardiovascular disease risk. In addition, we will&#xD;
      assess other parameters related to lipoprotein composition and function, as well as other&#xD;
      biomarkers related to coagulation and inflammation, which have previously been shown to be&#xD;
      affected by supplementation with omega-3 fatty acids.&#xD;
&#xD;
      This clinical research project is designed as a pilot, randomized, double-blinded, crossover&#xD;
      study that will investigate the effect of a fish oil enriched with LCMUFA on lipoprotein&#xD;
      metabolism. Subjects will receive control fish oil enriched in oleic acid, a monounsaturated&#xD;
      fatty acid (C18:1), or a fish oil supplement produced from Saury fish (rich in LCMUFA) for&#xD;
      approximately 8-10 weeks, with a wash out period of 8-10 weeks between the two arms of the&#xD;
      study. The study consists of 4 outpatient visits when laboratory or research samples and CAVI&#xD;
      tests will be performed. A 7-day food diary, pill count, and red cell membrane fatty acid&#xD;
      levels will be monitored to assess compliance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2017</start_date>
  <completion_date type="Actual">November 21, 2019</completion_date>
  <primary_completion_date type="Actual">May 29, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes From Baseline in Lipid Profile at 8 Weeks</measure>
    <time_frame>baseline and 8 weeks</time_frame>
    <description>The primary outcome measures of this study will be the change from baseline to end of intervention period (8 weeks) in the lipid profile (total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)) for the control and research supplement groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes Lipoprotein Particle Number, Composition and Size (sdLDL, LDL-TG, ApoE-HDL, ApoA-I, ApoB)</measure>
    <time_frame>baseline and 8 weeks</time_frame>
    <description>Secondary outcome measurements will be changes in proteomics, lipoprotein particle number, high-density lipoprotein (HDL) functional test (i.e. efflux study) composition and size. Secondary outcome will measure the following: Small dense low density lipoprotein (sdLDL); Low-Density Lipoprotein Triglycerides (LDL-TG); Apolipoprotein E-containing high-density lipoprotein (ApoE-HDL); apolipoprotein A-I (ApoA-I); Apolipoprotein B (ApoB).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes Lipoprotein Particle Number, Composition and Size in Oxidized Low-density Lipoprotein (oxLDL)</measure>
    <time_frame>baseline and 8 weeks</time_frame>
    <description>Secondary outcome measurements will be changes in proteomics, lipoprotein particle number, high-density lipoprotein (HDL) functional test (i.e. efflux study) composition and size.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Lipoprotein Metabolism</condition>
  <condition>PCSK9</condition>
  <condition>Proteomics</condition>
  <arm_group>
    <arm_group_label>Arm 1: Control Fish Oil first, then Saury Oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the LCMUFA-rich saury oil capsule arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2: Saury Oil first, then Control Fish Oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the control fish oil capsule arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Washout Period</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>8 week washout period to occur between week 8 and week 16. No study supplement taken by subject at this time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>control fish oil</intervention_name>
    <description>4 capsules, 3 times a day after meals</description>
    <arm_group_label>Arm 1: Control Fish Oil first, then Saury Oil</arm_group_label>
    <other_name>DHA, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), EPA (fish oils)</other_name>
    <other_name>fish oils, marine oils, N3 fatty acids, omega 3 polyunsaturated fatty acid (PUFA), polyunsaturated fatty acids,</other_name>
    <other_name>PUFA, W3 fatty acids</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LCMUFA-rich saury oil</intervention_name>
    <description>4 capsules, 3 times a day after meals</description>
    <arm_group_label>Arm 2: Saury Oil first, then Control Fish Oil</arm_group_label>
    <other_name>long-chain monounsaturated fatty acids</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Male and female participants 18 years of age or above.&#xD;
&#xD;
          -  Subject must be healthy, with no known history of cardiovascular disease.&#xD;
&#xD;
          -  Pre-menopausal or women of childbearing potential must be non-lactating and using an&#xD;
             effective form of birth control during the course of the study.&#xD;
&#xD;
          -  Subject understands protocol and provides written, informed consent in addition to a&#xD;
             willingness to comply with specified follow-up evaluations.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Pregnancy, planned pregnancy (within the study period) or women currently&#xD;
             breastfeeding.&#xD;
&#xD;
          -  Subjects with weight changes greater than 20% over the past 3 months.&#xD;
&#xD;
          -  Subjects planning a significant change in diet or exercise levels.&#xD;
&#xD;
          -  Subjects already consuming more than 1.5 g per day of eicosapentaenoic acid (EPA) or&#xD;
             docosahexaenoic acid (DHA) in any form.&#xD;
&#xD;
          -  Known sensitivity or allergy to fish, shellfish or omega-3 fatty acids supplements&#xD;
&#xD;
          -  Subjects with known bleeding disorders (for example, Hemophilia)&#xD;
&#xD;
          -  Subjects previously diagnosed with atrial fibrillation&#xD;
&#xD;
          -  Subjects with clinically diagnosed hepatic disease (including but not limited to auto&#xD;
             immune disease, hepatitis and cirrhosis)&#xD;
&#xD;
          -  Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel&#xD;
             motility problems, or other conditions that could affect intestinal fat absorption&#xD;
&#xD;
          -  Subjects with any acute and life-threatening condition, such as prior sudden cardiac&#xD;
             arrest, acute myocardial infarction (last three months), stroke, embolism&#xD;
&#xD;
          -  Liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase (ALT))&#xD;
             levels above 3x upper limit of normal&#xD;
&#xD;
          -  Subjects with a thyroid-stimulating hormone (TSH) greater than 1.5x upper limits of&#xD;
             normal (ULN) or clinical evidence of hypo or hyperthyroidism&#xD;
&#xD;
          -  Subjects taking supplements or medications that affect lipoproteins for at least the&#xD;
             past 8 weeks, such as fish oil supplements, bile-acid sequestrants, plant sterol&#xD;
             supplements, fibrates, statins or Niacin.&#xD;
&#xD;
          -  Subjects with hemoglobin &lt;10g/dL&#xD;
&#xD;
          -  Subject with platelet counts &lt;60x103/microliter&#xD;
&#xD;
          -  Subjects with uncontrolled hypertension (resting blood pressure &gt; 160 mmHg systolic&#xD;
             and /or &gt; 100 mm Hg diastolic)&#xD;
&#xD;
          -  Subject with uncontrolled diabetes (hemoglobin A1c (HbA1c) greater than or equal to&#xD;
             10)&#xD;
&#xD;
          -  Subjects who consume excessive alcohol (binge drinking on 5 or more days in the past&#xD;
             month)&#xD;
&#xD;
          -  Subject participating in other clinical studies and/or receiving other investigational&#xD;
             drug products prior to randomization&#xD;
&#xD;
          -  Subject taking PCSK9 inhibitors within 8 weeks prior to enrollment&#xD;
&#xD;
          -  Subjects being treated with tamoxifen, estrogens, or progestins that have not been&#xD;
             stable for &gt;4 weeks.&#xD;
&#xD;
          -  Subjects initiating new medications or patients on multiple medications may also be&#xD;
             excluded according to investigator discretion&#xD;
&#xD;
          -  Anticipated surgery during the study period&#xD;
&#xD;
          -  Blood donation in the last 2 weeks or planned blood donation during the study&#xD;
&#xD;
          -  Subjects requiring regular transfusions for any reason&#xD;
&#xD;
          -  Subjects may also be excluded for any reason that may compromise their safety or the&#xD;
             accuracy of research data.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcelo J Amar, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Heart, Lung, and Blood Institute (NHLBI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>February 3, 2017</study_first_submitted>
  <study_first_submitted_qc>February 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <results_first_submitted>May 26, 2020</results_first_submitted>
  <results_first_submitted_qc>August 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 12, 2020</results_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fish Oils</keyword>
  <keyword>Long Chain Monounsaturated Fatty Acids (LCMUFA)</keyword>
  <keyword>Lipoproteins</keyword>
  <keyword>Cardiovascular Disease</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 2, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03043365/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Thirty-seven healthy volunteers were recruited from June 2017 through March 2018 at the National Institutes of Health (NIH) (Bethesda, MD)</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Arm 1: Control Fish Oil Arm Then Saury Oil</title>
          <description>Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 plus or less 2 weeks and cross-over to the Long Chain Monounsaturated Fatty Acids (LCMUFA)-rich saury oil capsule arm control fish oil: 4 capsules, 3 times a day after meals</description>
        </group>
        <group group_id="P2">
          <title>Arm 2 - Saury Oil Arm Then Control Fish Oil</title>
          <description>Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the control fish oil capsule arm Long Chain Monounsaturated Fatty Acids (LCMUFA)-rich saury oil: 4 capsules, 3 times a day after meals</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Weeks 0 to Week 8</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Week 8 to Week 16 - Washout Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Week 16 to Week 24</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Arm 1: Control Fish Oil First, Then Saury Oil</title>
          <description>Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the LCMUFA-rich saury oil capsule arm control fish oil: 4 capsules, 3 times a day after meals</description>
        </group>
        <group group_id="B2">
          <title>Arm 2:Saury Oil First, Then Control Fish Oil</title>
          <description>Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the control fish oil capsule arm LCMUFA-rich saury oil: 4 capsules, 3 times a day after meals</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="37"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35" spread="12.6"/>
                    <measurement group_id="B2" value="32.3" spread="12.9"/>
                    <measurement group_id="B3" value="34.8" spread="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes From Baseline in Lipid Profile at 8 Weeks</title>
        <description>The primary outcome measures of this study will be the change from baseline to end of intervention period (8 weeks) in the lipid profile (total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)) for the control and research supplement groups.</description>
        <time_frame>baseline and 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm 1 - Control Fish Oil Arm</title>
            <description>Subjects randomized to the control fish oil arm will take 3g of control /day (12 gel capsules/day) for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Arm 2 - Saury Oil Arm</title>
            <description>Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline in Lipid Profile at 8 Weeks</title>
          <description>The primary outcome measures of this study will be the change from baseline to end of intervention period (8 weeks) in the lipid profile (total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)) for the control and research supplement groups.</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TG (mg/dL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52" spread="21.1"/>
                    <measurement group_id="O2" value="56.1" spread="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TC (mg/dL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="184.3" spread="45.6"/>
                    <measurement group_id="O2" value="181.7" spread="50.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL-C (mg/dL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.9" spread="16.9"/>
                    <measurement group_id="O2" value="68.7" spread="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL-C (mg/dL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102.7" spread="45.2"/>
                    <measurement group_id="O2" value="98.6" spread="50.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes Lipoprotein Particle Number, Composition and Size (sdLDL, LDL-TG, ApoE-HDL, ApoA-I, ApoB)</title>
        <description>Secondary outcome measurements will be changes in proteomics, lipoprotein particle number, high-density lipoprotein (HDL) functional test (i.e. efflux study) composition and size. Secondary outcome will measure the following: Small dense low density lipoprotein (sdLDL); Low-Density Lipoprotein Triglycerides (LDL-TG); Apolipoprotein E-containing high-density lipoprotein (ApoE-HDL); apolipoprotein A-I (ApoA-I); Apolipoprotein B (ApoB).</description>
        <time_frame>baseline and 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm 1 - Control Fish Oil Arm</title>
            <description>Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Arm 2 - Saury Oil Arm</title>
            <description>Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Changes Lipoprotein Particle Number, Composition and Size (sdLDL, LDL-TG, ApoE-HDL, ApoA-I, ApoB)</title>
          <description>Secondary outcome measurements will be changes in proteomics, lipoprotein particle number, high-density lipoprotein (HDL) functional test (i.e. efflux study) composition and size. Secondary outcome will measure the following: Small dense low density lipoprotein (sdLDL); Low-Density Lipoprotein Triglycerides (LDL-TG); Apolipoprotein E-containing high-density lipoprotein (ApoE-HDL); apolipoprotein A-I (ApoA-I); Apolipoprotein B (ApoB).</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>sdLDL (mg/dL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.7" spread="16.4"/>
                    <measurement group_id="O2" value="29" spread="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL-TG (mg/dL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.4" spread="6.3"/>
                    <measurement group_id="O2" value="14.7" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ApoE-HDL (mg/dL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread="1.7"/>
                    <measurement group_id="O2" value="6.5" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ApoA-I (mg/dL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158.3" spread="26.8"/>
                    <measurement group_id="O2" value="156.1" spread="30.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ApoB (mg/dL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.4" spread="31.1"/>
                    <measurement group_id="O2" value="89" spread="33.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes Lipoprotein Particle Number, Composition and Size in Oxidized Low-density Lipoprotein (oxLDL)</title>
        <description>Secondary outcome measurements will be changes in proteomics, lipoprotein particle number, high-density lipoprotein (HDL) functional test (i.e. efflux study) composition and size.</description>
        <time_frame>baseline and 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm 1 - Control Fish Oil Arm</title>
            <description>Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Arm 2 - Saury Oil Arm</title>
            <description>Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Changes Lipoprotein Particle Number, Composition and Size in Oxidized Low-density Lipoprotein (oxLDL)</title>
          <description>Secondary outcome measurements will be changes in proteomics, lipoprotein particle number, high-density lipoprotein (HDL) functional test (i.e. efflux study) composition and size.</description>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.3" spread="24.8"/>
                    <measurement group_id="O2" value="72.9" spread="26.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Arm 1: Control Fish Oil Arm</title>
          <description>Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 weeks</description>
        </group>
        <group group_id="E2">
          <title>Arm 2: Saury Oil Arm</title>
          <description>Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 weeks</description>
        </group>
        <group group_id="E3">
          <title>Washout Period</title>
          <description>No intervention administer to participants.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE version 4.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Toe Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Plantar fasciitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash acneiform</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Skin biopsy of left leg</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Marcelo J. Amar, M.D. Principal Investigator, NIH, NHLBI</name_or_title>
      <organization>National Heart Lung and Blood Institute (NHLBI)</organization>
      <phone>301-402-0521</phone>
      <email>mamar@nhlbi.nih.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03043365
org study id: 170050
secondary id: 17-H-0050
nct id: NCT03043365
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Background:

      Fish oils are known to be beneficial to health and believed to be cardio-protective. Omega-3
      fatty acid is the most known fish oil available in the market. LCMUFA (long-chain
      monounsaturated fatty acids) is also a fish oil but it is derived from fish that consumes a
      diet rich in omega-11 fatty acid. Researchers want to study omega-11 fatty acid enriched fish
      oil and understand its effect on cardiovascular health.

      Objective:

      To understand the effects of LCMUFA from fish oil on cardiovascular health.

      Eligibility:

      Healthy volunteers ages 18 and older with no history of cardiovascular disease

      Design:

      Participants will be screened with:

        -  Medical history

        -  Physical exam

        -  Fasting blood and urine tests

        -  Optional stool sample

        -  Questions about their diet, exercise, and the types of medicines and dietary supplements
           they take

        -  7-day food diary

        -  Cardio-Ankle Vascular Index (CAVI): Blood pressure is taken in the arms and legs. The
           heart is monitored.

        -  After the screening visit, participants will take 4 gel capsules, 3 times a day after
           meals, for 8-10 weeks.

        -  Electrocardiogram (EKG)

      Participants will have 3 additional visits. All include repeats of the screening tests.

      Visit 2 is 8 weeks after the screening visit. Participants will stop taking the capsules for
      8 weeks after this visit.

      Visit 3 is at least 16 weeks after starting the supplement. Participants will take 4
      capsules, 3 times a day after meals, for 8 weeks after this visit.

      Visit 4 is 8 weeks after starting the second supplement.
Serum cholesterol is transported by lipoproteins, such as very low-density lipoprotein
      (VLDL), low-density lipoproteins (LDL) and high-density lipoproteins (HDL), which vary in
      their relationship to cardiovascular disease risk. LDL, for example, is proatherogenic,
      whereas HDL is cardio-protective. Long-chain monounsaturated fatty acids (LCMUFA), fatty
      acids over 18 carbons in length with a single double bond, have been shown in mice to
      decrease proatherogenic lipoproteins, such as LDL, and reduce atherosclerosis. This study
      will test the hypothesis that LCMUFA supplementation in humans will favorably alter the
      lipoprotein lipid profile in regard to cardiovascular disease risk. In addition, we will
      assess other parameters related to lipoprotein composition and function, as well as other
      biomarkers related to coagulation and inflammation, which have previously been shown to be
      affected by supplementation with omega-3 fatty acids.

      This clinical research project is designed as a pilot, randomized, double-blinded, crossover
      study that will investigate the effect of a fish oil enriched with LCMUFA on lipoprotein
      metabolism. Subjects will receive control fish oil enriched in oleic acid, a monounsaturated
      fatty acid (C18:1), or a fish oil supplement produced from Saury fish (rich in LCMUFA) for
      approximately 8-10 weeks, with a wash out period of 8-10 weeks between the two arms of the
      study. The study consists of 4 outpatient visits when laboratory or research samples and CAVI
      tests will be performed. A 7-day food diary, pill count, and red cell membrane fatty acid
      levels will be monitored to assess compliance.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Changes From Baseline in Lipid Profile at 8 Weeks
time frame: baseline and 8 weeks
description: The primary outcome measures of this study will be the change from baseline to end of intervention period (8 weeks) in the lipid profile (total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)) for the control and research supplement groups.
measure: Changes Lipoprotein Particle Number, Composition and Size (sdLDL, LDL-TG, ApoE-HDL, ApoA-I, ApoB)
time frame: baseline and 8 weeks
description: Secondary outcome measurements will be changes in proteomics, lipoprotein particle number, high-density lipoprotein (HDL) functional test (i.e. efflux study) composition and size. Secondary outcome will measure the following: Small dense low density lipoprotein (sdLDL); Low-Density Lipoprotein Triglycerides (LDL-TG); Apolipoprotein E-containing high-density lipoprotein (ApoE-HDL); apolipoprotein A-I (ApoA-I); Apolipoprotein B (ApoB).
measure: Changes Lipoprotein Particle Number, Composition and Size in Oxidized Low-density Lipoprotein (oxLDL)
time frame: baseline and 8 weeks
description: Secondary outcome measurements will be changes in proteomics, lipoprotein particle number, high-density lipoprotein (HDL) functional test (i.e. efflux study) composition and size.
arm group label: Arm 1: Control Fish Oil first, then Saury Oil
arm group type: Experimental
description: Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the LCMUFA-rich saury oil capsule arm
arm group label: Arm 2: Saury Oil first, then Control Fish Oil
arm group type: Experimental
description: Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the control fish oil capsule arm
arm group label: Washout Period
arm group type: No Intervention
description: 8 week washout period to occur between week 8 and week 16. No study supplement taken by subject at this time.
intervention type: Drug
intervention name: control fish oil
description: 4 capsules, 3 times a day after meals
arm group label: Arm 1: Control Fish Oil first, then Saury Oil
other name: DHA, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), EPA (fish oils)
other name: fish oils, marine oils, N3 fatty acids, omega 3 polyunsaturated fatty acid (PUFA), polyunsaturated fatty acids,
other name: PUFA, W3 fatty acids
intervention type: Drug
intervention name: LCMUFA-rich saury oil
description: 4 capsules, 3 times a day after meals
arm group label: Arm 2: Saury Oil first, then Control Fish Oil
other name: long-chain monounsaturated fatty acids
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marcelo J Amar, M.D.
role: Principal Investigator
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
facility: 
country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 