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

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ClinicalTrials.gov Identifier: NCT01705678
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : October 12, 2012
Sponsor:
Information provided by (Responsible Party):
Ian G. Davies, Liverpool John Moores University

Tracking Information
First Submitted Date  ICMJE April 12, 2012
First Posted Date  ICMJE October 12, 2012
Last Update Posted Date October 12, 2012
Study Start Date  ICMJE May 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2012)
  • Change in Plasma Triglycerides at 3 weeks [ Time Frame: Change from baseline at 3 weeks ]
    Change in plasma triglycerides from baseline to midpoint
  • Change in plasma high density lipoprotein cholesterol at 3 weeks [ Time Frame: Change from baseline at 3 weeks ]
    Change in plasma High density lipoprotein cholesterol from baseline to midpoint
  • Change in plasma glucose at 3 weeks [ Time Frame: Change from baseline at 3 weeks ]
    Change in plasma glucose from baseline to midpoint
  • Change in waist circumference [ Time Frame: Change from baseline at 6 weeks ]
    Change in waist circumference from baseline to endpoint
  • Change in systolic blood pressure [ Time Frame: Change from baseline at 6 weeks ]
    Change in systolic blood pressure from baseline to endpoint
  • Change in Diastolic blood pressure [ Time Frame: Change from baseline at 6 weeks ]
    Change in diastolic blood pressure from baseline to endpoint
  • Change in plasma triglycerides at 6 weeks [ Time Frame: Change from baseline at 6 weeks ]
    Change in plasma triglycerides at baseline to endpoint
  • Change in plasma glucose at 6 weeks [ Time Frame: Change from baseline at 6 weeks ]
    Change in plasma glucose from baseline to endpoint
  • Change from baseline high density lipoprotein cholesterol at 6 weeks [ Time Frame: Change from baseline at 6 weeks ]
    Change in high density lipoprotein cholesterol from baseline to endpoint
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2012)
  • Change in Body mass [ Time Frame: Change from baseline at 6 weeks ]
    Change in body mass measured at baseline to endpoint
  • Change in plasma total cholesterol [ Time Frame: Change from baseline at 3 weeks ]
    Change in plasma cholesterol from baseline to midpoint
  • Change in body mass index [ Time Frame: Change from baseline at 6 weeks ]
    Change in body mass index at baseline to endpoint
  • Change in plasma cholesterol at 6 weeks [ Time Frame: Change from baseline at 6 weeks ]
    Change in plasma cholesterol from baseline to endpoint
  • Change in plasma insulin at 3 weeks [ Time Frame: Change from baseline at 3 weeks ]
    Change in plasma insulin from baseline to midpoint
  • Change in plasma insulin at 6 weeks [ Time Frame: Change from baseline at 6 weeks ]
    Change in plasma insulin from baseline to endpoint
  • Change in small, dense low density lipoprotein cholesterol at 6 weeks [ Time Frame: Change from baseline 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 [ Time Frame: Change from baseline at 3 weeks ]
    Change in plasma low density lipoprotein cholesterol from baseline to midpoint
  • Change in plasma low density lipoprotein cholesterol at 6 weeks [ Time Frame: Change from baseline at 6 weeks ]
    Change in plasma low density lipoprotein cholesterol from baseline to endpoint
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease
Official Title  ICMJE An Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease in Males With Metabolic Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Dietary Supplement: Krill oil
    Krill oil 300 mg DHA/EPA daily for 6 weeks
  • Dietary Supplement: Fish oil
    Fish oil 500 mg DHA/EPA daily for 6 weeks
Study Arms  ICMJE
  • Active Comparator: Krill oil
    Krill oil will be compared to fish oil as an active comparator
    Intervention: Dietary Supplement: Fish oil
  • Active Comparator: Fish oil
    Fish oil 500 mg of DHA/EPA
    Intervention: Dietary Supplement: Krill oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2012)
19
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01705678
Other Study ID Numbers  ICMJE KO-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ian G. Davies, Liverpool John Moores University
Study Sponsor  ICMJE Liverpool John Moores University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ian G Davies, PhD Liverpool John Moores University
PRS Account Liverpool John Moores University
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP