Clinical trial NCT01705678: Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Males
Metabolic syndrome
Otherwise healthy
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 19
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Change in Plasma Triglycerides at 3 weeks
timeFrame: Change from baseline at 3 weeks
measure: Change in plasma high density lipoprotein cholesterol at 3 weeks
timeFrame: Change from baseline at 3 weeks
measure: Change in plasma glucose at 3 weeks
timeFrame: Change from baseline at 3 weeks
measure: Change in waist circumference
timeFrame: Change from baseline at 6 weeks
measure: Change in systolic blood pressure
timeFrame: Change from baseline at 6 weeks
measure: Change in Diastolic blood pressure
timeFrame: Change from baseline at 6 weeks
measure: Change in plasma triglycerides at 6 weeks
timeFrame: Change from baseline at 6 weeks
measure: Change in plasma glucose at 6 weeks
timeFrame: Change from baseline at 6 weeks
measure: Change from baseline high density lipoprotein cholesterol at 6 weeks
timeFrame: Change from baseline at 6 weeks
Secondary outcomes:
measure: Change in Body mass
timeFrame: Change from baseline at 6 weeks
measure: Change in plasma total cholesterol
timeFrame: Change from baseline at 3 weeks
measure: Change in body mass index
timeFrame: Change from baseline at 6 weeks
measure: Change in plasma cholesterol at 6 weeks
timeFrame: Change from baseline at 6 weeks
measure: Change in plasma insulin at 3 weeks
timeFrame: Change from baseline at 3 weeks
measure: Change in plasma insulin at 6 weeks
timeFrame: Change from baseline at 6 weeks
measure: Change in small, dense low density lipoprotein cholesterol at 6 weeks
timeFrame: Change from baseline at 6 weeks
measure: Change in plasma low density lipoprotein cholesterol at 3 weeks
timeFrame: Change from baseline at 3 weeks
measure: Change in plasma low density lipoprotein cholesterol at 6 weeks
timeFrame: Change from baseline at 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Liverpool John Moores University
name: Ian G Davies, PhD
role: PRINCIPAL_INVESTIGATOR
References: