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

NCT01705678 | Completed

• 1 other identifier: KO-001
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (9)

• Change in Body mass

  Change from baseline at 6 weeks

• Change in plasma total cholesterol

  Change from baseline at 3 weeks

• Change in body mass index

  Change from baseline at 6 weeks

• Change in plasma cholesterol at 6 weeks

  Change from baseline at 6 weeks

• Change in plasma insulin at 3 weeks

  Change from baseline at 3 weeks

Study Arms (2)

Krill oil

ACTIVE COMPARATOR

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

Dietary Supplement: Fish oil

Fish oil

ACTIVE COMPARATOR

Fish oil 500 mg of DHA/EPA

Dietary Supplement: Krill oil

Interventions

Krill oil DIETARY_SUPPLEMENT

Krill oil 300 mg DHA/EPA daily for 6 weeks

Fish oil

Fish oil DIETARY_SUPPLEMENT

Fish oil 500 mg DHA/EPA daily for 6 weeks

Krill oil

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Liverpool John Moores University: lead

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Ian G Davies, PhD

  Liverpool John Moores University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Ian G. Davies

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: October 12, 2012
• Study Start: May 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: March 1, 2012
• Last Updated: October 12, 2012

Record last verified: 2012-10