<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/NCT01705678</url>
  </required_header>
  <id_info>
    <org_study_id>KO-001</org_study_id>
    <nct_id>NCT01705678</nct_id>
  </id_info>
  <brief_title>Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease</brief_title>
  <official_title>An Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease in Males With Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liverpool John Moores University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Liverpool John Moores University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is some evidence that dietary supplementation with fish oil has health benefits,&#xD;
      especially in respect of some of the known risk factors for cardiovascular (heart) disease&#xD;
      such as cardiac arrhythmia. However, supplies of fish oil are limited, and it is desirable to&#xD;
      validate alternative sustainable sources of the important omega-3 fatty acid components. It&#xD;
      has been suggested that oil from krill, which are small marine crustaceans, may be as&#xD;
      effective or possibly more beneficial than fish oil, and may provide a more effective and&#xD;
      beneficial supplement. Dietary management of cardiovascular health parameters (such as blood&#xD;
      lipids)is becoming more and more important as the rising trends in obesity nationally and&#xD;
      worldwide are leading to escalating incidence of diabetes and heart disease. The&#xD;
      investigators propose to use some specific novel lipid measurements of cardiovascular risk to&#xD;
      test this possibility in a group of men who, although generally healthy, show some risk&#xD;
      factors in terms of their weight and metabolic profile.This pilot study will provide&#xD;
      preliminary data to show whether krill oil has similar or different effects from fish oil on&#xD;
      the cardiovascular health of overweight but otherwise healthy men, and in particular will&#xD;
      provide detailed information on alterations in novel lipid markers of cardiovascular disease,&#xD;
      which may be a better diagnostic tool than classical lipid measurements (e.g. serum&#xD;
      cholesterol). The investigators have been developing and validating new techniques to measure&#xD;
      emerging lipid markers of cardiovascular risk accurately and will continue to develop and&#xD;
      investigate these techniques during the course of this project. The investigators hypothesise&#xD;
      that krill oil will be more efficacious in reducing markers of risk relating to&#xD;
      cardiovascular disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">September 2010</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Plasma Triglycerides at 3 weeks</measure>
    <time_frame>Change from baseline at 3 weeks</time_frame>
    <description>Change in plasma triglycerides from baseline to midpoint</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in plasma high density lipoprotein cholesterol at 3 weeks</measure>
    <time_frame>Change from baseline at 3 weeks</time_frame>
    <description>Change in plasma High density lipoprotein cholesterol from baseline to midpoint</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in plasma glucose at 3 weeks</measure>
    <time_frame>Change from baseline at 3 weeks</time_frame>
    <description>Change in plasma glucose from baseline to midpoint</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>Change from baseline at 6 weeks</time_frame>
    <description>Change in waist circumference from baseline to endpoint</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in systolic blood pressure</measure>
    <time_frame>Change from baseline at 6 weeks</time_frame>
    <description>Change in systolic blood pressure from baseline to endpoint</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Diastolic blood pressure</measure>
    <time_frame>Change from baseline at 6 weeks</time_frame>
    <description>Change in diastolic blood pressure from baseline to endpoint</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in plasma triglycerides at 6 weeks</measure>
    <time_frame>Change from baseline at 6 weeks</time_frame>
    <description>Change in plasma triglycerides at baseline to endpoint</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in plasma glucose at 6 weeks</measure>
    <time_frame>Change from baseline at 6 weeks</time_frame>
    <description>Change in plasma glucose from baseline to endpoint</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline high density lipoprotein cholesterol at 6 weeks</measure>
    <time_frame>Change from baseline at 6 weeks</time_frame>
    <description>Change in high density lipoprotein cholesterol from baseline to endpoint</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Body mass</measure>
    <time_frame>Change from baseline at 6 weeks</time_frame>
    <description>Change in body mass measured at baseline to endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma total cholesterol</measure>
    <time_frame>Change from baseline at 3 weeks</time_frame>
    <description>Change in plasma cholesterol from baseline to midpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body mass index</measure>
    <time_frame>Change from baseline at 6 weeks</time_frame>
    <description>Change in body mass index at baseline to endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma cholesterol at 6 weeks</measure>
    <time_frame>Change from baseline at 6 weeks</time_frame>
    <description>Change in plasma cholesterol from baseline to endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma insulin at 3 weeks</measure>
    <time_frame>Change from baseline at 3 weeks</time_frame>
    <description>Change in plasma insulin from baseline to midpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma insulin at 6 weeks</measure>
    <time_frame>Change from baseline at 6 weeks</time_frame>
    <description>Change in plasma insulin from baseline to endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in small, dense low density lipoprotein cholesterol at 6 weeks</measure>
    <time_frame>Change from baseline at 6 weeks</time_frame>
    <description>Change in small, dense low density lipoprotein cholesterol from baseline to endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma low density lipoprotein cholesterol at 3 weeks</measure>
    <time_frame>Change from baseline at 3 weeks</time_frame>
    <description>Change in plasma low density lipoprotein cholesterol from baseline to midpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma low density lipoprotein cholesterol at 6 weeks</measure>
    <time_frame>Change from baseline at 6 weeks</time_frame>
    <description>Change in plasma low density lipoprotein cholesterol from baseline to endpoint</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Krill oil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Krill oil will be compared to fish oil as an active comparator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fish oil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fish oil 500 mg of DHA/EPA</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Krill oil</intervention_name>
    <description>Krill oil 300 mg DHA/EPA daily for 6 weeks</description>
    <arm_group_label>Fish oil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fish oil</intervention_name>
    <description>Fish oil 500 mg DHA/EPA daily for 6 weeks</description>
    <arm_group_label>Krill oil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  waist circumference ≥ 94cm&#xD;
&#xD;
        Plus any two of the below:&#xD;
&#xD;
          -  Raised triglycerides : ≥ 150 mg/dL (1.7 mmol/L)&#xD;
&#xD;
          -  Reduced HDL cholesterol: &lt; 40 mg/dL (1.03 mmol/L)&#xD;
&#xD;
          -  Raised blood pressure: ≥ 130/85 mm Hg&#xD;
&#xD;
          -  Raised fasting plasma glucose: ≥ 100 mg/dL (5.6 mmol/L)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Drug treatment for cardiovascular disease or diabetes,&#xD;
&#xD;
          -  currently taking fish oil supplements&#xD;
&#xD;
          -  Individuals who would require carers or guardians to make decisions&#xD;
&#xD;
          -  Known history of liver disease&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ian G Davies, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liverpool John Moores University</affiliation>
  </overall_official>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>April 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>October 11, 2012</last_update_submitted>
  <last_update_submitted_qc>October 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Liverpool John Moores University</investigator_affiliation>
    <investigator_full_name>Ian G. Davies</investigator_full_name>
    <investigator_title>Dr Ian G. Davies</investigator_title>
  </responsible_party>
  <keyword>Males</keyword>
  <keyword>Metabolic syndrome</keyword>
  <keyword>Otherwise healthy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT01705678
org study id: KO-001
nct id: NCT01705678
lead sponsor: 
has dmc: No
There is some evidence that dietary supplementation with fish oil has health benefits,
      especially in respect of some of the known risk factors for cardiovascular (heart) disease
      such as cardiac arrhythmia. However, supplies of fish oil are limited, and it is desirable to
      validate alternative sustainable sources of the important omega-3 fatty acid components. It
      has been suggested that oil from krill, which are small marine crustaceans, may be as
      effective or possibly more beneficial than fish oil, and may provide a more effective and
      beneficial supplement. Dietary management of cardiovascular health parameters (such as blood
      lipids)is becoming more and more important as the rising trends in obesity nationally and
      worldwide are leading to escalating incidence of diabetes and heart disease. The
      investigators propose to use some specific novel lipid measurements of cardiovascular risk to
      test this possibility in a group of men who, although generally healthy, show some risk
      factors in terms of their weight and metabolic profile.This pilot study will provide
      preliminary data to show whether krill oil has similar or different effects from fish oil on
      the cardiovascular health of overweight but otherwise healthy men, and in particular will
      provide detailed information on alterations in novel lipid markers of cardiovascular disease,
      which may be a better diagnostic tool than classical lipid measurements (e.g. serum
      cholesterol). The investigators have been developing and validating new techniques to measure
      emerging lipid markers of cardiovascular risk accurately and will continue to develop and
      investigate these techniques during the course of this project. The investigators hypothesise
      that krill oil will be more efficacious in reducing markers of risk relating to
      cardiovascular disease.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change in Plasma Triglycerides at 3 weeks
time frame: Change from baseline at 3 weeks
description: Change in plasma triglycerides from baseline to midpoint
measure: Change in plasma high density lipoprotein cholesterol at 3 weeks
time frame: Change from baseline at 3 weeks
description: Change in plasma High density lipoprotein cholesterol from baseline to midpoint
measure: Change in plasma glucose at 3 weeks
time frame: Change from baseline at 3 weeks
description: Change in plasma glucose from baseline to midpoint
measure: Change in waist circumference
time frame: Change from baseline at 6 weeks
description: Change in waist circumference from baseline to endpoint
measure: Change in systolic blood pressure
time frame: Change from baseline at 6 weeks
description: Change in systolic blood pressure from baseline to endpoint
measure: Change in Diastolic blood pressure
time frame: Change from baseline at 6 weeks
description: Change in diastolic blood pressure from baseline to endpoint
measure: Change in plasma triglycerides at 6 weeks
time frame: Change from baseline at 6 weeks
description: Change in plasma triglycerides at baseline to endpoint
measure: Change in plasma glucose at 6 weeks
time frame: Change from baseline at 6 weeks
description: Change in plasma glucose from baseline to endpoint
measure: Change from baseline high density lipoprotein cholesterol at 6 weeks
time frame: Change from baseline at 6 weeks
description: Change in high density lipoprotein cholesterol from baseline to endpoint
measure: Change in Body mass
time frame: Change from baseline at 6 weeks
description: Change in body mass measured at baseline to endpoint
measure: Change in plasma total cholesterol
time frame: Change from baseline at 3 weeks
description: Change in plasma cholesterol from baseline to midpoint
measure: Change in body mass index
time frame: Change from baseline at 6 weeks
description: Change in body mass index at baseline to endpoint
measure: Change in plasma cholesterol at 6 weeks
time frame: Change from baseline at 6 weeks
description: Change in plasma cholesterol from baseline to endpoint
measure: Change in plasma insulin at 3 weeks
time frame: Change from baseline at 3 weeks
description: Change in plasma insulin from baseline to midpoint
measure: Change in plasma insulin at 6 weeks
time frame: Change from baseline at 6 weeks
description: Change in plasma insulin from baseline to endpoint
measure: Change in small, dense low density lipoprotein cholesterol at 6 weeks
time frame: Change from baseline at 6 weeks
description: Change in small, dense low density lipoprotein cholesterol from baseline to endpoint
measure: Change in plasma low density lipoprotein cholesterol at 3 weeks
time frame: Change from baseline at 3 weeks
description: Change in plasma low density lipoprotein cholesterol from baseline to midpoint
measure: Change in plasma low density lipoprotein cholesterol at 6 weeks
time frame: Change from baseline at 6 weeks
description: Change in plasma low density lipoprotein cholesterol from baseline to endpoint
arm group label: Krill oil
arm group type: Active Comparator
description: Krill oil will be compared to fish oil as an active comparator
arm group label: Fish oil
arm group type: Active Comparator
description: Fish oil 500 mg of DHA/EPA
intervention type: Dietary Supplement
intervention name: Krill oil
description: Krill oil 300 mg DHA/EPA daily for 6 weeks
arm group label: Fish oil
intervention type: Dietary Supplement
intervention name: Fish oil
description: Fish oil 500 mg DHA/EPA daily for 6 weeks
arm group label: Krill oil
criteria: 
gender: Male
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ian G Davies, PhD
role: Principal Investigator
affiliation: Liverpool John Moores University
responsible party type: Principal Investigator
investigator affiliation: Liverpool John Moores University
investigator full name: Ian G. Davies
investigator title: Dr Ian G. Davies
mesh term: Cardiovascular Diseases
mesh term: Metabolic Syndrome
mesh term: Syndrome