Skip to main content
OpenTrials
Completed

NCT Number: NCT01705678

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Krill oil

Dietary Supplement

Krill oil 300 mg DHA/EPA daily for 6 weeks

Fish Oil

Dietary Supplement

Fish oil 500 mg DHA/EPA daily for 6 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Liverpool John Moores University

Other

Registry information

Official study title

An Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease in Males With Metabolic Syndrome

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Oct 12, 2012
Registry last updated
Oct 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.