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

NCT ID: NCT01705678

Last Updated: 2012-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-03-31

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.

Conditions

Metabolic Syndrome

Keywords

Males; Metabolic syndrome; Otherwise healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Krill oil

Krill oil will be compared to fish oil as an active comparator

Group Type: ACTIVE_COMPARATOR

Fish oil

Intervention Type: DIETARY_SUPPLEMENT

Fish oil 500 mg DHA/EPA daily for 6 weeks

Fish oil

Fish oil 500 mg of DHA/EPA

Group Type: ACTIVE_COMPARATOR

Krill oil

Intervention Type: DIETARY_SUPPLEMENT

Krill oil 300 mg DHA/EPA daily for 6 weeks

Interventions

Krill oil

Krill oil 300 mg DHA/EPA daily for 6 weeks

Intervention Type: DIETARY_SUPPLEMENT

Fish oil

Fish oil 500 mg DHA/EPA daily for 6 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Liverpool John Moores University

OTHER

Sponsor Role: lead

Responsible Party

Ian G. Davies

Dr Ian G. Davies

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ian G Davies, PhD

Role: PRINCIPAL_INVESTIGATOR

Liverpool John Moores University

Other Identifiers

KO-001

Identifier Type: -

Identifier Source: org_study_id