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

Not Applicable
Completed
Conditions
Metabolic Syndrome
Interventions
Dietary Supplement: Fish oil
Dietary Supplement: Krill oil
Registration Number
NCT01705678
Lead Sponsor
Liverpool John Moores University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
19
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Krill oilFish oilKrill oil will be compared to fish oil as an active comparator
Fish oilKrill oilFish oil 500 mg of DHA/EPA
Primary Outcome Measures
NameTimeMethod
Change in Plasma Triglycerides at 3 weeksChange from baseline at 3 weeks

Change in plasma triglycerides from baseline to midpoint

Change in plasma high density lipoprotein cholesterol at 3 weeksChange from baseline at 3 weeks

Change in plasma High density lipoprotein cholesterol from baseline to midpoint

Change in plasma glucose at 3 weeksChange from baseline at 3 weeks

Change in plasma glucose from baseline to midpoint

Change in waist circumferenceChange from baseline at 6 weeks

Change in waist circumference from baseline to endpoint

Change in systolic blood pressureChange from baseline at 6 weeks

Change in systolic blood pressure from baseline to endpoint

Change in Diastolic blood pressureChange from baseline at 6 weeks

Change in diastolic blood pressure from baseline to endpoint

Change in plasma triglycerides at 6 weeksChange from baseline at 6 weeks

Change in plasma triglycerides at baseline to endpoint

Change in plasma glucose at 6 weeksChange from baseline at 6 weeks

Change in plasma glucose from baseline to endpoint

Change from baseline high density lipoprotein cholesterol at 6 weeksChange from baseline at 6 weeks

Change in high density lipoprotein cholesterol from baseline to endpoint

Secondary Outcome Measures
NameTimeMethod
Change in Body massChange from baseline at 6 weeks

Change in body mass measured at baseline to endpoint

Change in plasma total cholesterolChange from baseline at 3 weeks

Change in plasma cholesterol from baseline to midpoint

Change in body mass indexChange from baseline at 6 weeks

Change in body mass index at baseline to endpoint

Change in plasma cholesterol at 6 weeksChange from baseline at 6 weeks

Change in plasma cholesterol from baseline to endpoint

Change in plasma insulin at 3 weeksChange from baseline at 3 weeks

Change in plasma insulin from baseline to midpoint

Change in plasma insulin at 6 weeksChange from baseline at 6 weeks

Change in plasma insulin from baseline to endpoint

Change in small, dense low density lipoprotein cholesterol at 6 weeksChange 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 weeksChange 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 weeksChange from baseline at 6 weeks

Change in plasma low density lipoprotein cholesterol from baseline to endpoint

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