Metabolic Syndrome
Conditions
Keywords
Males, Metabolic syndrome, Otherwise healthy
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.
Interventions
DIETARY_SUPPLEMENTKrill oil
Krill oil 300 mg DHA/EPA daily for 6 weeks
DIETARY_SUPPLEMENTFish oil
Fish oil 500 mg DHA/EPA daily for 6 weeks
Sponsors
Liverpool John Moores University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
35 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline high density lipoprotein cholesterol at 6 weeks | Change from baseline at 6 weeks | Change in high density lipoprotein cholesterol from baseline to endpoint |
| Change in Plasma Triglycerides at 3 weeks | Change from baseline at 3 weeks | Change in plasma triglycerides from baseline to midpoint |
| Change in plasma high density lipoprotein cholesterol at 3 weeks | Change from baseline at 3 weeks | Change in plasma High density lipoprotein cholesterol from baseline to midpoint |
| Change in plasma glucose at 3 weeks | Change from baseline at 3 weeks | Change in plasma glucose from baseline to midpoint |
| Change in waist circumference | Change from baseline at 6 weeks | Change in waist circumference from baseline to endpoint |
| Change in systolic blood pressure | Change from baseline at 6 weeks | Change in systolic blood pressure from baseline to endpoint |
| Change in Diastolic blood pressure | Change from baseline at 6 weeks | Change in diastolic blood pressure from baseline to endpoint |
| Change in plasma triglycerides at 6 weeks | Change from baseline at 6 weeks | Change in plasma triglycerides at baseline to endpoint |
| Change in plasma glucose at 6 weeks | Change from baseline at 6 weeks | Change in plasma glucose from baseline to endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body mass | Change from baseline at 6 weeks | Change in body mass measured at baseline to endpoint |
| Change in plasma total cholesterol | Change from baseline at 3 weeks | Change in plasma cholesterol from baseline to midpoint |
| Change in body mass index | Change from baseline at 6 weeks | Change in body mass index at baseline to endpoint |
| Change in plasma cholesterol at 6 weeks | Change from baseline at 6 weeks | Change in plasma cholesterol from baseline to endpoint |
| Change in plasma insulin at 3 weeks | Change from baseline at 3 weeks | Change in plasma insulin from baseline to midpoint |
| Change in plasma insulin at 6 weeks | Change from baseline at 6 weeks | Change in plasma insulin from baseline to endpoint |
| Change in small, dense low density lipoprotein cholesterol at 6 weeks | Change from baseline at 6 weeks | Change in small, dense low density lipoprotein cholesterol from baseline to endpoint |
| Change in plasma low density lipoprotein cholesterol at 3 weeks | Change from baseline at 3 weeks | Change in plasma low density lipoprotein cholesterol from baseline to midpoint |
| Change in plasma low density lipoprotein cholesterol at 6 weeks | Change from baseline at 6 weeks | Change in plasma low density lipoprotein cholesterol from baseline to endpoint |
Outcome results
None listed