<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/NCT01690312</url>
  </required_header>
  <id_info>
    <org_study_id>11-09-002</org_study_id>
    <secondary_id>150038</secondary_id>
    <nct_id>NCT01690312</nct_id>
  </id_info>
  <brief_title>Clinical Study to Assess High-DHA Fish Oil on Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy</brief_title>
  <official_title>Clinical Study to Assess the Acute and Chronic Effects of a High-DHA Fish Oil on Fasting and Post-Prandial Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nutrasource Pharmaceutical and Nutraceutical Services, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biodroga Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Guelph</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nutrasource Pharmaceutical and Nutraceutical Services, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to determine the acute and chronic [4-week] effects of a&#xD;
      high-DHA fish oil supplement on fasting and post-prandial (post-meal) biomarkers of&#xD;
      cardiovascular disease risk, in adults on Statin therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study involves fasted and post-prandial components.&#xD;
&#xD;
      Fasted Study:&#xD;
&#xD;
      Participants will provide fasting blood samples pre-and post-intervention [4-week&#xD;
      administration of supplement or placebo] in Treatment Period I. Participants will again&#xD;
      provide fasting blood samples pre-and post-intervention [4-week administration of supplement&#xD;
      or placebo, opposite to Treatment Period I] during Treatment Period II.&#xD;
&#xD;
      There will be a 4-week washout period during the two Treatment Periods.&#xD;
&#xD;
      Post-prandial study:&#xD;
&#xD;
      Participants will also complete a post-prandial study pre-and post-intervention during each&#xD;
      Treatment Period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">December 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Triglyceride [TG]</measure>
    <time_frame>0 and 4 weeks</time_frame>
    <description>Fasted and postprandial samples will be drawn (hourly up to 6 hours).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>0 and 4 weeks</time_frame>
    <description>Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin</measure>
    <time_frame>0 and 4 weeks</time_frame>
    <description>Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol [TC]</measure>
    <time_frame>0 and 4 weeks</time_frame>
    <description>A fasted blood sample will be taken.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High-density lipoprotein [HDL]</measure>
    <time_frame>0 and 4 weeks</time_frame>
    <description>A fasted blood sample will be taken.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low-density lipoprotein [LDL]</measure>
    <time_frame>0 and 4 weeks</time_frame>
    <description>A fasted blood sample will be taken.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Very low-density lipoprotein [VLDL]</measure>
    <time_frame>0 and 4 weeks</time_frame>
    <description>A fasted blood sample will be taken.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipoprotein A</measure>
    <time_frame>0 and 4 weeks</time_frame>
    <description>A fasted blood sample will be taken.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intermediate-density lipoprotein [IDL]</measure>
    <time_frame>0 and 4 weeks</time_frame>
    <description>A fasted blood sample will be taken.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remnant Lipoproteins</measure>
    <time_frame>0 and 4 weeks</time_frame>
    <description>A fasted blood sample will be taken.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High-sensitivity C-Reactive Protein [hs-CRP]</measure>
    <time_frame>0 and 4 weeks</time_frame>
    <description>A fasted blood sample will be taken.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Homocysteine</measure>
    <time_frame>0 and 4 weeks</time_frame>
    <description>A fasted blood sample will be taken.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Essential Fatty Acid Profile</measure>
    <time_frame>0 and 4 weeks</time_frame>
    <description>A fasted blood sample will be taken.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apolipoprotein B</measure>
    <time_frame>0 and 4 weeks</time_frame>
    <description>A fasted blood sample will be taken.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apolipoprotein A-1</measure>
    <time_frame>0 and 4 weeks</time_frame>
    <description>A fasted blood sample will be taken.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>1 (Dietary Supplement - Fish Oil)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On Day 1 &amp; Day 29, the researcher will obtain anthropometric measurements as specified in the study protocol. A venous catheter will be inserted and a fasted blood sample will be drawn, which will be analyzed for study primary and secondary endpoints. Participants will consume a Breakfast Meal (which will represent t0) and will have blood drawn at a total of 7 time points. Blood samples drawn at30, t60, t120, and t180 will be analyzed for glucose and insulin; blood samples drawn at t60, t120, t180, t240, t300 and t360 will be analyzed for triglycerides. Upon completion of the 6 hour blood draw period, the venous catheter will be removed.&#xD;
On Day 15, the researcher will obtain anthropometric measurements as specified in the study protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 (Placebo)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On Day 1 &amp; Day 29, the researcher will obtain anthropometric measurements as specified in the study protocol. A venous catheter will be inserted and a fasted blood sample will be drawn, which will be analyzed for study primary and secondary endpoints. Participants will consume a Breakfast Meal (which will represent t0) and will have blood drawn at a total of 7 time points. Blood samples drawn at30, t60, t120, and t180 will be analyzed for glucose and insulin; blood samples drawn at t60, t120, t180, t240, t300 and t360 will be analyzed for triglycerides. Upon completion of the 6 hour blood draw period, the venous catheter will be removed.&#xD;
On Day 15, the researcher will obtain anthropometric measurements as specified in the study protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fish Oil</intervention_name>
    <description>On Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day. Each capsule contains 1000 mg of fish oil [620 mg of DHA and 150 mg of EPA], providing a total daily dosage of 4000 mg of fish oil [3080 mg of DHA+EPA].</description>
    <arm_group_label>1 (Dietary Supplement - Fish Oil)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>On Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day. Each capsule contains 1000 mg of olive oil, providing a total daily dosage of 4000 mg of olive oil.</description>
    <arm_group_label>2 (Placebo)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be an adult between the ages of 18 and 70;&#xD;
&#xD;
          -  Be a male or a post-menopausal female who has gone a minimum of one year since their&#xD;
             last menses;&#xD;
&#xD;
          -  Be taking Statin medication at a stable dose for a minimum of four weeks prior to&#xD;
             study commencement [and whom have reached a target LDL level];&#xD;
&#xD;
          -  Have elevated fasting triglyceride levels [greater than 1.5 mmol/L but less than 5.7&#xD;
             mmol/L];&#xD;
&#xD;
          -  Have fasting blood glucose levels below the study cut-off [less than 7.0 mmol/L];&#xD;
&#xD;
          -  Have a Body Mass Index (BMI) less than 35.0&#xD;
&#xD;
          -  Be taking natural health products BUT agree to cease consumption during the study&#xD;
             period and a 4-week pre-study washout prior to study commencement. Study participants&#xD;
             will be allowed to consume a daily multivitamin if they have been doing so at a stable&#xD;
             dose for a minimum of three months prior to study commencement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Be younger than 18 years of age or older than 70 years of age;&#xD;
&#xD;
          -  Be an adult pre- or peri-menopausal female;&#xD;
&#xD;
          -  Not have taken Statin medication at a stable dose for a minimum of 4 weeks prior to&#xD;
             study commencement;&#xD;
&#xD;
          -  Have fasting triglyceride levels outside of study limits[ie/ less than 1.5 mmol/L or&#xD;
             greater than 5.7 mmol/L];&#xD;
&#xD;
          -  Have elevated fasting blood glucose levels [greater or equal to 7.0 mmol/L];&#xD;
&#xD;
          -  Have high blood pressure [greater than 140/100]&#xD;
&#xD;
          -  Have a Body Mass Index (BMI) equal to or greater than 35.0&#xD;
&#xD;
          -  Have a pre-existing cardiovascular disease or illness, including angina, myocardial&#xD;
             infarction, stroke, intermittent claudication or transient ischemic attack;&#xD;
&#xD;
          -  Have a known allergy to fish and/or fish oil, olive oil, soy or Vitamin E;&#xD;
&#xD;
          -  Be taking natural health products but are unwilling to cease consumption during the&#xD;
             study period and a 4-week pre-study washout prior to study commencement;&#xD;
&#xD;
          -  Consume more than two (2) fish meals on a weekly basis&#xD;
&#xD;
          -  Consume excessive amounts of alcohol on a weekly basis [more than 10 alcoholic drinks&#xD;
             per week];&#xD;
&#xD;
          -  Anticipate or have planned surgery during the course of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alison Duncan, Ph.D., R.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Guelph</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nutrasource Diagnostics Inc.</name>
      <address>
        <city>Guelph</city>
        <state>Ontario</state>
        <zip>N1G 0B4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>February 6, 2014</last_update_submitted>
  <last_update_submitted_qc>February 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Humans</keyword>
  <keyword>Cardiovascular Disease</keyword>
  <keyword>Statins</keyword>
  <keyword>Fish Oil</keyword>
  <keyword>DHA</keyword>
  <keyword>EPA</keyword>
  <keyword>High-DHA</keyword>
  <keyword>Triglycerides</keyword>
  <keyword>Total cholesterol [TC]</keyword>
  <keyword>Lipoproteins</keyword>
  <keyword>High-density lipoprotein [HDL2, HDL3]</keyword>
  <keyword>Low-density lipoprotein [LDL1+2+3+4]</keyword>
  <keyword>Lipoprotein A [Lp(a)]</keyword>
  <keyword>Intermediate-density lipoprotein (IDL)</keyword>
  <keyword>Very low-density lipoprotein (VLDL1+2, VLDL3)</keyword>
  <keyword>Remnant Lipoproteins</keyword>
  <keyword>High-sensitivity C-Reactive Protein [hs-CRP]</keyword>
  <keyword>Homocysteine</keyword>
  <keyword>Essential Fatty Acid Profile</keyword>
  <keyword>Apolipoprotein B</keyword>
  <keyword>Apolipoprotein A-1</keyword>
  <keyword>Glucose</keyword>
  <keyword>Insulin</keyword>
  <keyword>Fasted</keyword>
  <keyword>Post-Prandial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT01690312
org study id: 11-09-002
secondary id: 150038
nct id: NCT01690312
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The objective of this study is to determine the acute and chronic [4-week] effects of a
      high-DHA fish oil supplement on fasting and post-prandial (post-meal) biomarkers of
      cardiovascular disease risk, in adults on Statin therapy.
This study involves fasted and post-prandial components.

      Fasted Study:

      Participants will provide fasting blood samples pre-and post-intervention [4-week
      administration of supplement or placebo] in Treatment Period I. Participants will again
      provide fasting blood samples pre-and post-intervention [4-week administration of supplement
      or placebo, opposite to Treatment Period I] during Treatment Period II.

      There will be a 4-week washout period during the two Treatment Periods.

      Post-prandial study:

      Participants will also complete a post-prandial study pre-and post-intervention during each
      Treatment Period.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Triglyceride [TG]
time frame: 0 and 4 weeks
description: Fasted and postprandial samples will be drawn (hourly up to 6 hours).
measure: Glucose
time frame: 0 and 4 weeks
description: Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours).
measure: Insulin
time frame: 0 and 4 weeks
description: Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours).
measure: Total cholesterol [TC]
time frame: 0 and 4 weeks
description: A fasted blood sample will be taken.
measure: High-density lipoprotein [HDL]
time frame: 0 and 4 weeks
description: A fasted blood sample will be taken.
measure: Low-density lipoprotein [LDL]
time frame: 0 and 4 weeks
description: A fasted blood sample will be taken.
measure: Very low-density lipoprotein [VLDL]
time frame: 0 and 4 weeks
description: A fasted blood sample will be taken.
measure: Lipoprotein A
time frame: 0 and 4 weeks
description: A fasted blood sample will be taken.
measure: Intermediate-density lipoprotein [IDL]
time frame: 0 and 4 weeks
description: A fasted blood sample will be taken.
measure: Remnant Lipoproteins
time frame: 0 and 4 weeks
description: A fasted blood sample will be taken.
measure: High-sensitivity C-Reactive Protein [hs-CRP]
time frame: 0 and 4 weeks
description: A fasted blood sample will be taken.
measure: Homocysteine
time frame: 0 and 4 weeks
description: A fasted blood sample will be taken.
measure: Essential Fatty Acid Profile
time frame: 0 and 4 weeks
description: A fasted blood sample will be taken.
measure: Apolipoprotein B
time frame: 0 and 4 weeks
description: A fasted blood sample will be taken.
measure: Apolipoprotein A-1
time frame: 0 and 4 weeks
description: A fasted blood sample will be taken.
arm group label: 1 (Dietary Supplement - Fish Oil)
arm group type: Experimental
description: On Day 1 & Day 29, the researcher will obtain anthropometric measurements as specified in the study protocol. A venous catheter will be inserted and a fasted blood sample will be drawn, which will be analyzed for study primary and secondary endpoints. Participants will consume a Breakfast Meal (which will represent t0) and will have blood drawn at a total of 7 time points. Blood samples drawn at30, t60, t120, and t180 will be analyzed for glucose and insulin; blood samples drawn at t60, t120, t180, t240, t300 and t360 will be analyzed for triglycerides. Upon completion of the 6 hour blood draw period, the venous catheter will be removed.
On Day 15, the researcher will obtain anthropometric measurements as specified in the study protocol.
arm group label: 2 (Placebo)
arm group type: Experimental
description: On Day 1 & Day 29, the researcher will obtain anthropometric measurements as specified in the study protocol. A venous catheter will be inserted and a fasted blood sample will be drawn, which will be analyzed for study primary and secondary endpoints. Participants will consume a Breakfast Meal (which will represent t0) and will have blood drawn at a total of 7 time points. Blood samples drawn at30, t60, t120, and t180 will be analyzed for glucose and insulin; blood samples drawn at t60, t120, t180, t240, t300 and t360 will be analyzed for triglycerides. Upon completion of the 6 hour blood draw period, the venous catheter will be removed.
On Day 15, the researcher will obtain anthropometric measurements as specified in the study protocol.
intervention type: Dietary Supplement
intervention name: Fish Oil
description: On Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day. Each capsule contains 1000 mg of fish oil [620 mg of DHA and 150 mg of EPA], providing a total daily dosage of 4000 mg of fish oil [3080 mg of DHA+EPA].
arm group label: 1 (Dietary Supplement - Fish Oil)
intervention type: Dietary Supplement
intervention name: Placebo
description: On Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day. Each capsule contains 1000 mg of olive oil, providing a total daily dosage of 4000 mg of olive oil.
arm group label: 2 (Placebo)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Alison Duncan, Ph.D., R.D.
role: Principal Investigator
affiliation: University of Guelph
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Cardiovascular Diseases