Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Krill oil
Fish oil
Sponsored by
About this trial
This is an interventional basic science trial for Metabolic Syndrome focused on measuring Males, Metabolic syndrome, Otherwise healthy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Krill oil
Fish oil
Arm Description
Krill oil will be compared to fish oil as an active comparator
Fish oil 500 mg of DHA/EPA
Outcomes
Primary Outcome Measures
Change in Plasma Triglycerides at 3 weeks
Change in plasma triglycerides from baseline to midpoint
Change in plasma high density lipoprotein cholesterol at 3 weeks
Change in plasma High density lipoprotein cholesterol from baseline to midpoint
Change in plasma glucose at 3 weeks
Change in plasma glucose from baseline to midpoint
Change in waist circumference
Change in waist circumference from baseline to endpoint
Change in systolic blood pressure
Change in systolic blood pressure from baseline to endpoint
Change in Diastolic blood pressure
Change in diastolic blood pressure from baseline to endpoint
Change in plasma triglycerides at 6 weeks
Change in plasma triglycerides at baseline to endpoint
Change in plasma glucose at 6 weeks
Change in plasma glucose from baseline to endpoint
Change from baseline high density lipoprotein cholesterol at 6 weeks
Change in high density lipoprotein cholesterol from baseline to endpoint
Secondary Outcome Measures
Change in Body mass
Change in body mass measured at baseline to endpoint
Change in plasma total cholesterol
Change in plasma cholesterol from baseline to midpoint
Change in body mass index
Change in body mass index at baseline to endpoint
Change in plasma cholesterol at 6 weeks
Change in plasma cholesterol from baseline to endpoint
Change in plasma insulin at 3 weeks
Change in plasma insulin from baseline to midpoint
Change in plasma insulin at 6 weeks
Change in plasma insulin from baseline to endpoint
Change in small, dense low density lipoprotein cholesterol 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 in plasma low density lipoprotein cholesterol from baseline to midpoint
Change in plasma low density lipoprotein cholesterol at 6 weeks
Change in plasma low density lipoprotein cholesterol from baseline to endpoint
Full Information
NCT ID
NCT01705678
First Posted
April 12, 2012
Last Updated
October 11, 2012
Sponsor
Liverpool John Moores University
1. Study Identification
Unique Protocol Identification Number
NCT01705678
Brief Title
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
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liverpool John Moores University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Males, Metabolic syndrome, Otherwise healthy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Krill oil
Arm Type
Active Comparator
Arm Description
Krill oil will be compared to fish oil as an active comparator
Arm Title
Fish oil
Arm Type
Active Comparator
Arm Description
Fish oil 500 mg of DHA/EPA
Intervention Type
Dietary Supplement
Intervention Name(s)
Krill oil
Intervention Description
Krill oil 300 mg DHA/EPA daily for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil
Intervention Description
Fish oil 500 mg DHA/EPA daily for 6 weeks
Primary Outcome Measure Information:
Title
Change in Plasma Triglycerides at 3 weeks
Description
Change in plasma triglycerides from baseline to midpoint
Time Frame
Change from baseline at 3 weeks
Title
Change in plasma high density lipoprotein cholesterol at 3 weeks
Description
Change in plasma High density lipoprotein cholesterol from baseline to midpoint
Time Frame
Change from baseline at 3 weeks
Title
Change in plasma glucose at 3 weeks
Description
Change in plasma glucose from baseline to midpoint
Time Frame
Change from baseline at 3 weeks
Title
Change in waist circumference
Description
Change in waist circumference from baseline to endpoint
Time Frame
Change from baseline at 6 weeks
Title
Change in systolic blood pressure
Description
Change in systolic blood pressure from baseline to endpoint
Time Frame
Change from baseline at 6 weeks
Title
Change in Diastolic blood pressure
Description
Change in diastolic blood pressure from baseline to endpoint
Time Frame
Change from baseline at 6 weeks
Title
Change in plasma triglycerides at 6 weeks
Description
Change in plasma triglycerides at baseline to endpoint
Time Frame
Change from baseline at 6 weeks
Title
Change in plasma glucose at 6 weeks
Description
Change in plasma glucose from baseline to endpoint
Time Frame
Change from baseline at 6 weeks
Title
Change from baseline high density lipoprotein cholesterol at 6 weeks
Description
Change in high density lipoprotein cholesterol from baseline to endpoint
Time Frame
Change from baseline at 6 weeks
Secondary Outcome Measure Information:
Title
Change in Body mass
Description
Change in body mass measured at baseline to endpoint
Time Frame
Change from baseline at 6 weeks
Title
Change in plasma total cholesterol
Description
Change in plasma cholesterol from baseline to midpoint
Time Frame
Change from baseline at 3 weeks
Title
Change in body mass index
Description
Change in body mass index at baseline to endpoint
Time Frame
Change from baseline at 6 weeks
Title
Change in plasma cholesterol at 6 weeks
Description
Change in plasma cholesterol from baseline to endpoint
Time Frame
Change from baseline at 6 weeks
Title
Change in plasma insulin at 3 weeks
Description
Change in plasma insulin from baseline to midpoint
Time Frame
Change from baseline at 3 weeks
Title
Change in plasma insulin at 6 weeks
Description
Change in plasma insulin from baseline to endpoint
Time Frame
Change from baseline at 6 weeks
Title
Change in small, dense low density lipoprotein cholesterol at 6 weeks
Description
Change in small, dense low density lipoprotein cholesterol from baseline to endpoint
Time Frame
Change from baseline at 6 weeks
Title
Change in plasma low density lipoprotein cholesterol at 3 weeks
Description
Change in plasma low density lipoprotein cholesterol from baseline to midpoint
Time Frame
Change from baseline at 3 weeks
Title
Change in plasma low density lipoprotein cholesterol at 6 weeks
Description
Change in plasma low density lipoprotein cholesterol from baseline to endpoint
Time Frame
Change from baseline at 6 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian G Davies, PhD
Organizational Affiliation
Liverpool John Moores University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease
We'll reach out to this number within 24 hrs