search
Back to results

Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Krill oil
Fish oil
Sponsored by
Liverpool John Moores University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome focused on measuring Males, Metabolic syndrome, Otherwise healthy

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • waist circumference ≥ 94cm

Plus any two of the below:

  • Raised triglycerides : ≥ 150 mg/dL (1.7 mmol/L)
  • Reduced HDL cholesterol: < 40 mg/dL (1.03 mmol/L)
  • Raised blood pressure: ≥ 130/85 mm Hg
  • Raised fasting plasma glucose: ≥ 100 mg/dL (5.6 mmol/L)

Exclusion Criteria:

  • Drug treatment for cardiovascular disease or diabetes,
  • currently taking fish oil supplements
  • Individuals who would require carers or guardians to make decisions
  • Known history of liver disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Krill oil

    Fish oil

    Arm Description

    Krill oil will be compared to fish oil as an active comparator

    Fish oil 500 mg of DHA/EPA

    Outcomes

    Primary Outcome Measures

    Change in Plasma Triglycerides at 3 weeks
    Change in plasma triglycerides from baseline to midpoint
    Change in plasma high density lipoprotein cholesterol at 3 weeks
    Change in plasma High density lipoprotein cholesterol from baseline to midpoint
    Change in plasma glucose at 3 weeks
    Change in plasma glucose from baseline to midpoint
    Change in waist circumference
    Change in waist circumference from baseline to endpoint
    Change in systolic blood pressure
    Change in systolic blood pressure from baseline to endpoint
    Change in Diastolic blood pressure
    Change in diastolic blood pressure from baseline to endpoint
    Change in plasma triglycerides at 6 weeks
    Change in plasma triglycerides at baseline to endpoint
    Change in plasma glucose at 6 weeks
    Change in plasma glucose from baseline to endpoint
    Change from baseline high density lipoprotein cholesterol at 6 weeks
    Change in high density lipoprotein cholesterol from baseline to endpoint

    Secondary Outcome Measures

    Change in Body mass
    Change in body mass measured at baseline to endpoint
    Change in plasma total cholesterol
    Change in plasma cholesterol from baseline to midpoint
    Change in body mass index
    Change in body mass index at baseline to endpoint
    Change in plasma cholesterol at 6 weeks
    Change in plasma cholesterol from baseline to endpoint
    Change in plasma insulin at 3 weeks
    Change in plasma insulin from baseline to midpoint
    Change in plasma insulin at 6 weeks
    Change in plasma insulin from baseline to endpoint
    Change in small, dense low density lipoprotein cholesterol at 6 weeks
    Change in small, dense low density lipoprotein cholesterol from baseline to endpoint
    Change in plasma low density lipoprotein cholesterol at 3 weeks
    Change in plasma low density lipoprotein cholesterol from baseline to midpoint
    Change in plasma low density lipoprotein cholesterol at 6 weeks
    Change in plasma low density lipoprotein cholesterol from baseline to endpoint

    Full Information

    First Posted
    April 12, 2012
    Last Updated
    October 11, 2012
    Sponsor
    Liverpool John Moores University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01705678
    Brief Title
    Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease
    Official Title
    An Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease in Males With Metabolic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2009 (undefined)
    Primary Completion Date
    September 2010 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Liverpool John Moores University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome
    Keywords
    Males, Metabolic syndrome, Otherwise healthy

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Krill oil
    Arm Type
    Active Comparator
    Arm Description
    Krill oil will be compared to fish oil as an active comparator
    Arm Title
    Fish oil
    Arm Type
    Active Comparator
    Arm Description
    Fish oil 500 mg of DHA/EPA
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Krill oil
    Intervention Description
    Krill oil 300 mg DHA/EPA daily for 6 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Fish oil
    Intervention Description
    Fish oil 500 mg DHA/EPA daily for 6 weeks
    Primary Outcome Measure Information:
    Title
    Change in Plasma Triglycerides at 3 weeks
    Description
    Change in plasma triglycerides from baseline to midpoint
    Time Frame
    Change from baseline at 3 weeks
    Title
    Change in plasma high density lipoprotein cholesterol at 3 weeks
    Description
    Change in plasma High density lipoprotein cholesterol from baseline to midpoint
    Time Frame
    Change from baseline at 3 weeks
    Title
    Change in plasma glucose at 3 weeks
    Description
    Change in plasma glucose from baseline to midpoint
    Time Frame
    Change from baseline at 3 weeks
    Title
    Change in waist circumference
    Description
    Change in waist circumference from baseline to endpoint
    Time Frame
    Change from baseline at 6 weeks
    Title
    Change in systolic blood pressure
    Description
    Change in systolic blood pressure from baseline to endpoint
    Time Frame
    Change from baseline at 6 weeks
    Title
    Change in Diastolic blood pressure
    Description
    Change in diastolic blood pressure from baseline to endpoint
    Time Frame
    Change from baseline at 6 weeks
    Title
    Change in plasma triglycerides at 6 weeks
    Description
    Change in plasma triglycerides at baseline to endpoint
    Time Frame
    Change from baseline at 6 weeks
    Title
    Change in plasma glucose at 6 weeks
    Description
    Change in plasma glucose from baseline to endpoint
    Time Frame
    Change from baseline at 6 weeks
    Title
    Change from baseline high density lipoprotein cholesterol at 6 weeks
    Description
    Change in high density lipoprotein cholesterol from baseline to endpoint
    Time Frame
    Change from baseline at 6 weeks
    Secondary Outcome Measure Information:
    Title
    Change in Body mass
    Description
    Change in body mass measured at baseline to endpoint
    Time Frame
    Change from baseline at 6 weeks
    Title
    Change in plasma total cholesterol
    Description
    Change in plasma cholesterol from baseline to midpoint
    Time Frame
    Change from baseline at 3 weeks
    Title
    Change in body mass index
    Description
    Change in body mass index at baseline to endpoint
    Time Frame
    Change from baseline at 6 weeks
    Title
    Change in plasma cholesterol at 6 weeks
    Description
    Change in plasma cholesterol from baseline to endpoint
    Time Frame
    Change from baseline at 6 weeks
    Title
    Change in plasma insulin at 3 weeks
    Description
    Change in plasma insulin from baseline to midpoint
    Time Frame
    Change from baseline at 3 weeks
    Title
    Change in plasma insulin at 6 weeks
    Description
    Change in plasma insulin from baseline to endpoint
    Time Frame
    Change from baseline at 6 weeks
    Title
    Change in small, dense low density lipoprotein cholesterol at 6 weeks
    Description
    Change in small, dense low density lipoprotein cholesterol from baseline to endpoint
    Time Frame
    Change from baseline at 6 weeks
    Title
    Change in plasma low density lipoprotein cholesterol at 3 weeks
    Description
    Change in plasma low density lipoprotein cholesterol from baseline to midpoint
    Time Frame
    Change from baseline at 3 weeks
    Title
    Change in plasma low density lipoprotein cholesterol at 6 weeks
    Description
    Change in plasma low density lipoprotein cholesterol from baseline to endpoint
    Time Frame
    Change from baseline at 6 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: waist circumference ≥ 94cm Plus any two of the below: Raised triglycerides : ≥ 150 mg/dL (1.7 mmol/L) Reduced HDL cholesterol: < 40 mg/dL (1.03 mmol/L) Raised blood pressure: ≥ 130/85 mm Hg Raised fasting plasma glucose: ≥ 100 mg/dL (5.6 mmol/L) Exclusion Criteria: Drug treatment for cardiovascular disease or diabetes, currently taking fish oil supplements Individuals who would require carers or guardians to make decisions Known history of liver disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ian G Davies, PhD
    Organizational Affiliation
    Liverpool John Moores University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease

    We'll reach out to this number within 24 hrs