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

Study Overview
=================
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.

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

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Krill oil
* Dietary Supplement: Fish oil


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Krill oil<br>Krill oil will be compared to fish oil as an active comparator | Dietary Supplement: Fish oil<br>* Fish oil 500 mg DHA/EPA daily for 6 weeks<br>|
| Active Comparator: Fish oil<br>Fish oil 500 mg of DHA/EPA | Dietary Supplement: Krill oil<br>* Krill oil 300 mg DHA/EPA daily for 6 weeks<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Males, Metabolic syndrome, Otherwise healthy