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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705678
• Other study ID #: KO-001
• Status: Completed
• Phase: N/A
• First received: April 12, 2012
• Last updated: October 11, 2012
• Start date: May 2009
• Est. completion date: March 2012

Study information

• Verified date: October 2012
• Source: Liverpool John Moores University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2012
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool John Moores University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Plasma Triglycerides at 3 weeks	Change in plasma triglycerides from baseline to midpoint	Change from baseline at 3 weeks	No
Primary	Change in plasma high density lipoprotein cholesterol at 3 weeks	Change in plasma High density lipoprotein cholesterol from baseline to midpoint	Change from baseline at 3 weeks	No
Primary	Change in plasma glucose at 3 weeks	Change in plasma glucose from baseline to midpoint	Change from baseline at 3 weeks	No
Primary	Change in waist circumference	Change in waist circumference from baseline to endpoint	Change from baseline at 6 weeks	No
Primary	Change in systolic blood pressure	Change in systolic blood pressure from baseline to endpoint	Change from baseline at 6 weeks	No
Primary	Change in Diastolic blood pressure	Change in diastolic blood pressure from baseline to endpoint	Change from baseline at 6 weeks	No
Primary	Change in plasma triglycerides at 6 weeks	Change in plasma triglycerides at baseline to endpoint	Change from baseline at 6 weeks	No
Primary	Change in plasma glucose at 6 weeks	Change in plasma glucose from baseline to endpoint	Change from baseline at 6 weeks	No
Primary	Change from baseline high density lipoprotein cholesterol at 6 weeks	Change in high density lipoprotein cholesterol from baseline to endpoint	Change from baseline at 6 weeks	No
Secondary	Change in Body mass	Change in body mass measured at baseline to endpoint	Change from baseline at 6 weeks	No
Secondary	Change in plasma total cholesterol	Change in plasma cholesterol from baseline to midpoint	Change from baseline at 3 weeks	No
Secondary	Change in body mass index	Change in body mass index at baseline to endpoint	Change from baseline at 6 weeks	No
Secondary	Change in plasma cholesterol at 6 weeks	Change in plasma cholesterol from baseline to endpoint	Change from baseline at 6 weeks	No
Secondary	Change in plasma insulin at 3 weeks	Change in plasma insulin from baseline to midpoint	Change from baseline at 3 weeks	No
Secondary	Change in plasma insulin at 6 weeks	Change in plasma insulin from baseline to endpoint	Change from baseline at 6 weeks	No
Secondary	Change in small, dense low density lipoprotein cholesterol at 6 weeks	Change in small, dense low density lipoprotein cholesterol from baseline to endpoint	Change from baseline at 6 weeks	No
Secondary	Change in plasma low density lipoprotein cholesterol at 3 weeks	Change in plasma low density lipoprotein cholesterol from baseline to midpoint	Change from baseline at 3 weeks	No
Secondary	Change in plasma low density lipoprotein cholesterol at 6 weeks	Change in plasma low density lipoprotein cholesterol from baseline to endpoint	Change from baseline at 6 weeks	No