Metabolic SyndromeNCT01705678
Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease
A study testing Krill oil and Fish oil in people with Metabolic Syndrome, run by Liverpool John Moores University.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Krill oil and Fish oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: An Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease in Males With Metabolic Syndrome
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.
- Conditions
- Metabolic Syndrome
- Being tested
- Krill oil, Fish oil
- Keywords
- Males, Metabolic syndrome, Otherwise healthy
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Krill oilDietary supplement
Krill oil 300 mg DHA/EPA daily for 6 weeks
Fish oilDietary supplement
Fish oil 500 mg DHA/EPA daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Krill oil | Active comparator | Krill oil will be compared to fish oil as an active comparator Receives: Dietary Supplement: Fish oil |
| Fish oil | Active comparator | Fish oil 500 mg of DHA/EPA Receives: Dietary Supplement: Krill oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma Triglycerides at 3 weeks
Change in plasma triglycerides from baseline to midpoint
Measured: 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
Measured: Change from baseline at 3 weeks
Change in plasma glucose at 3 weeks
Change in plasma glucose from baseline to midpoint
Measured: Change from baseline at 3 weeks
Change in waist circumference
Change in waist circumference from baseline to endpoint
Measured: Change from baseline at 6 weeks
Change in systolic blood pressure
Change in systolic blood pressure from baseline to endpoint
Measured: Change from baseline at 6 weeks
Change in Diastolic blood pressure
Change in diastolic blood pressure from baseline to endpoint
Measured: Change from baseline at 6 weeks
Change in plasma triglycerides at 6 weeks
Change in plasma triglycerides at baseline to endpoint
Measured: Change from baseline at 6 weeks
Change in plasma glucose at 6 weeks
Change in plasma glucose from baseline to endpoint
Measured: 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
Measured: Change from baseline at 6 weeks
Secondary outcomes (9)
Change in Body mass
Change in body mass measured at baseline to endpoint
Measured: Change from baseline at 6 weeks
Change in plasma total cholesterol
Change in plasma cholesterol from baseline to midpoint
Measured: Change from baseline at 3 weeks
Change in body mass index
Change in body mass index at baseline to endpoint
Measured: Change from baseline at 6 weeks
Change in plasma cholesterol at 6 weeks
Change in plasma cholesterol from baseline to endpoint
Measured: Change from baseline at 6 weeks
Change in plasma insulin at 3 weeks
Change in plasma insulin from baseline to midpoint
Measured: Change from baseline at 3 weeks
Change in plasma insulin at 6 weeks
Change in plasma insulin from baseline to endpoint
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startMay 2009
- Primary completionSep 2010
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian G. Davies, Liverpool John Moores University
- Investigators
- Ian G Davies, PhD, Principal investigator, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705678
- Sponsor's protocol ID
- KO-001
- Status last verified
- Oct 2012
- First submitted
- 12 Apr 2012
- Last updated
- 12 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease in Males With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01705678
- Acronym / sponsor ID
- KO-001
- Conditions
- Metabolic Syndrome
- Keywords
- Males, Metabolic syndrome, Otherwise healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Krill oil | Active comparator | Dietary Supplement: Fish oilKrill oil will be compared to fish oil as an active comparator |
| Fish oil | Active comparator | Dietary Supplement: Krill oilFish oil 500 mg of DHA/EPA |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- waist circumference ≥ 94cm
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Krill oilKrill oil 300 mg DHA/EPA daily for 6 weeks | Dietary supplement | Fish oil |
| Fish oilFish oil 500 mg DHA/EPA daily for 6 weeks | Dietary supplement | Krill oil |
Primary outcome
Change in Plasma Triglycerides at 3 weeks
Time frame: Change from baseline at 3 weeks
Change in plasma triglycerides from baseline to midpoint
Change in plasma high density lipoprotein cholesterol at 3 weeks
Time frame: Change from baseline at 3 weeks
Change in plasma High density lipoprotein cholesterol from baseline to midpoint
Change in plasma glucose at 3 weeks
Time frame: Change from baseline at 3 weeks
Change in plasma glucose from baseline to midpoint
Change in waist circumference
Time frame: Change from baseline at 6 weeks
Change in waist circumference from baseline to endpoint
Change in systolic blood pressure
Time frame: Change from baseline at 6 weeks
Change in systolic blood pressure from baseline to endpoint
Change in Diastolic blood pressure
Time frame: Change from baseline at 6 weeks
Change in diastolic blood pressure from baseline to endpoint
Change in plasma triglycerides at 6 weeks
Time frame: Change from baseline at 6 weeks
Change in plasma triglycerides at baseline to endpoint
Change in plasma glucose at 6 weeks
Time frame: Change from baseline at 6 weeks
Change in plasma glucose from baseline to endpoint
Change from baseline high density lipoprotein cholesterol at 6 weeks
Time frame: Change from baseline at 6 weeks
Change in high density lipoprotein cholesterol from baseline to endpoint
9 secondary outcomes
Change in Body mass
Time frame: Change from baseline at 6 weeks
Change in plasma total cholesterol
Time frame: Change from baseline at 3 weeks
Change in body mass index
Time frame: Change from baseline at 6 weeks
Change in plasma cholesterol at 6 weeks
Time frame: Change from baseline at 6 weeks
Change in plasma insulin at 3 weeks
Time frame: Change from baseline at 3 weeks
Change in plasma insulin at 6 weeks
Time frame: Change from baseline at 6 weeks
Change in small, dense low density lipoprotein cholesterol at 6 weeks
Time frame: Change from baseline at 6 weeks
Change in plasma low density lipoprotein cholesterol at 3 weeks
Time frame: Change from baseline at 3 weeks
Change in plasma low density lipoprotein cholesterol at 6 weeks
Time frame: Change from baseline at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian G Davies, PhD principal investigator
Liverpool John Moores University
Questions about this trial
What is this clinical trial studying?
A study testing Krill oil and Fish oil in people with Metabolic Syndrome, run by Liverpool John Moores University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma Triglycerides at 3 weeks (time frame: Change from baseline at 3 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2012.