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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

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Krill oil Dietary Supplement: Fish oil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: An Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease in Males With Metabolic Syndrome
Study Start Date : May 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arm Intervention/treatment
Active Comparator: Krill oil
Krill oil will be compared to fish oil as an active comparator
Dietary Supplement: Fish oil
Fish oil 500 mg DHA/EPA daily for 6 weeks

Active Comparator: Fish oil
Fish oil 500 mg of DHA/EPA
Dietary Supplement: Krill oil
Krill oil 300 mg DHA/EPA daily for 6 weeks




Primary Outcome Measures :
  1. Change in Plasma Triglycerides at 3 weeks [ Time Frame: Change from baseline at 3 weeks ]
    Change in plasma triglycerides from baseline to midpoint

  2. 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

  3. Change in plasma glucose at 3 weeks [ Time Frame: Change from baseline at 3 weeks ]
    Change in plasma glucose from baseline to midpoint

  4. Change in waist circumference [ Time Frame: Change from baseline at 6 weeks ]
    Change in waist circumference from baseline to endpoint

  5. Change in systolic blood pressure [ Time Frame: Change from baseline at 6 weeks ]
    Change in systolic blood pressure from baseline to endpoint

  6. Change in Diastolic blood pressure [ Time Frame: Change from baseline at 6 weeks ]
    Change in diastolic blood pressure from baseline to endpoint

  7. Change in plasma triglycerides at 6 weeks [ Time Frame: Change from baseline at 6 weeks ]
    Change in plasma triglycerides at baseline to endpoint

  8. Change in plasma glucose at 6 weeks [ Time Frame: Change from baseline at 6 weeks ]
    Change in plasma glucose from baseline to endpoint

  9. 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


Secondary Outcome Measures :
  1. Change in Body mass [ Time Frame: Change from baseline at 6 weeks ]
    Change in body mass measured at baseline to endpoint

  2. Change in plasma total cholesterol [ Time Frame: Change from baseline at 3 weeks ]
    Change in plasma cholesterol from baseline to midpoint

  3. Change in body mass index [ Time Frame: Change from baseline at 6 weeks ]
    Change in body mass index at baseline to endpoint

  4. Change in plasma cholesterol at 6 weeks [ Time Frame: Change from baseline at 6 weeks ]
    Change in plasma cholesterol from baseline to endpoint

  5. Change in plasma insulin at 3 weeks [ Time Frame: Change from baseline at 3 weeks ]
    Change in plasma insulin from baseline to midpoint

  6. Change in plasma insulin at 6 weeks [ Time Frame: Change from baseline at 6 weeks ]
    Change in plasma insulin from baseline to endpoint

  7. 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

  8. 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

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705678


Sponsors and Collaborators
Liverpool John Moores University
Investigators
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Principal Investigator: Ian G Davies, PhD Liverpool John Moores University

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Responsible Party: Ian G. Davies, Dr Ian G. Davies, Liverpool John Moores University
ClinicalTrials.gov Identifier: NCT01705678     History of Changes
Other Study ID Numbers: KO-001
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: October 12, 2012
Last Verified: October 2012
Keywords provided by Ian G. Davies, Liverpool John Moores University:
Males
Metabolic syndrome
Otherwise healthy
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Cardiovascular Diseases
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases