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

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Fish oil; Dietary supplement: Krill oil

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Plasma Triglycerides at 3 weeks	Change in plasma triglycerides from baseline to midpoint	Change from baseline at 3 weeks
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
Change in plasma glucose at 3 weeks	Change in plasma glucose from baseline to midpoint	Change from baseline at 3 weeks
Change in waist circumference	Change in waist circumference from baseline to endpoint	Change from baseline at 6 weeks
Change in systolic blood pressure	Change in systolic blood pressure from baseline to endpoint	Change from baseline at 6 weeks
Change in Diastolic blood pressure	Change in diastolic blood pressure from baseline to endpoint	Change from baseline at 6 weeks
Change in plasma triglycerides at 6 weeks	Change in plasma triglycerides at baseline to endpoint	Change from baseline at 6 weeks
Change in plasma glucose at 6 weeks	Change in plasma glucose from baseline to endpoint	Change from baseline at 6 weeks
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body mass	Change in body mass measured at baseline to endpoint	Change from baseline at 6 weeks
Change in plasma total cholesterol	Change in plasma cholesterol from baseline to midpoint	Change from baseline at 3 weeks
Change in body mass index	Change in body mass index at baseline to endpoint	Change from baseline at 6 weeks
Change in plasma cholesterol at 6 weeks	Change in plasma cholesterol from baseline to endpoint	Change from baseline at 6 weeks
Change in plasma insulin at 3 weeks	Change in plasma insulin from baseline to midpoint	Change from baseline at 3 weeks
Change in plasma insulin at 6 weeks	Change in plasma insulin from baseline to endpoint	Change from baseline at 6 weeks
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
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
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

Collaborators and Investigators

• Sponsor: Liverpool John Moores University
• Investigators: Principal Investigator: Ian G Davies, PhD, Liverpool John Moores University

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ACTUAL): September 1, 2010
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: April 12, 2012
• First Submitted That Met QC Criteria: October 11, 2012
• First Posted (ESTIMATE): October 12, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 12, 2012
• Last Update Submitted That Met QC Criteria: October 11, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Males; Otherwise healthy
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: KO-001