Stable Atherosclerotic Coronary DiseaseNCT01092793
Effect of Superba Krill on Inflammation in Patients With Coronary Artery Disease
A study testing Krill and Fish oil in people with Stable Atherosclerotic Coronary Disease, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Atherosclerotic coronary heart disease is a condition thought to involve low-grade inflammation. Several reports, clinical and epidemiological, have demonstrated that intake of fish oil may be beneficial in attenuating the inflammatory process. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stable Atherosclerotic Coronary Disease
- What is being tested?
- Krill and Fish oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2010to Jan 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-80 years
- Sex: Male and female
- Stable atherosclerotic coronary heart disease (heart attack >3 months ago or objectified angina pectoris).
- No hospitalization for heart disease last 3 months.
Who cannot join
- Unstable heart disease.
- Heart failure NYHA class III and IV.
- Previous valve and/or aortic surgery
- Significant concomitant disease (i.e. diseases with known inflammatory activation - e.g. various autoimmune diseases, chronic infections, significant acute infections three weeks before or during the study, connective tissue disease, arthritis, chronic pulmonary disease or serious liver- or kidney-disease).
- Simultaneous involvement in other clinical studies involving intervention.
- Planned operation or other invasive procedures (e.g. PCI etc.) during the study period.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Cardiology, Oslo University Hospital / Rikshospitalet
Oslo, 0027
About this study
Atherosclerotic coronary heart disease is a condition thought to involve low-grade inflammation. Several reports, clinical and epidemiological, have demonstrated that intake of fish oil may be beneficial in attenuating the inflammatory process. Still, however, there are lacking data in respect to whether differences in composition of various marine oils may influence the inflammatory status differently.
The hypothesis of the current study is that extract from the antarctic krill (Euphausia superba) is better than traditional fish oils when compared head-to-head with balanced composition of omega 3 content on inflammatory status.
- Conditions
- Stable Atherosclerotic Coronary Disease
- Being tested
- Krill, Fish oil
- Keywords
- Fish oil, Krill, CAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KrillDietary supplement
Encapsulated oil from the antarctic crustacean Krill
Fish oilDietary supplement
Encapsulated, raffined cod-oil
| Study group | Role | What they receive |
|---|---|---|
| Krill | Active comparator | Not described Receives: Dietary Supplement: Krill |
| Fish oil | Active comparator | Not described Receives: Dietary Supplement: Fish oil |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory blood status
Measured: 8 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Atherosclerotic Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092793
- Sponsor's protocol ID
- Krill-2010
- Status last verified
- Mar 2010
- First submitted
- 23 Mar 2010
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Superba Krill on Inflammation in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01092793
- Acronym / sponsor ID
- Krill-2010
- Conditions
- Stable Atherosclerotic Coronary Disease
- Keywords
- Fish oil, Krill, CAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 Mar 2010 (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.
Atherosclerotic coronary heart disease is a condition thought to involve low-grade inflammation. Several reports, clinical and epidemiological, have demonstrated that intake of fish oil may be beneficial in attenuating the inflammatory process. Still, however, there are lacking data in respect to whether differences in composition of various marine oils may influence the inflammatory status differently.
The hypothesis of the current study is that extract from the antarctic krill (Euphausia superba) is better than traditional fish oils when compared head-to-head with balanced composition of omega 3 content on inflammatory status.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Krill | Active comparator | Dietary Supplement: Krill |
| Fish oil | Active comparator | Dietary Supplement: Fish oil |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18-80 years
- Sex: Male and female
- Stable atherosclerotic coronary heart disease (heart attack >3 months ago or objectified angina pectoris).
- No hospitalization for heart disease last 3 months.
Key exclusion criteria (6 listed)
- Unstable heart disease.
- Heart failure NYHA class III and IV.
- Previous valve and/or aortic surgery
- Significant concomitant disease (i.e. diseases with known inflammatory activation - e.g. various autoimmune diseases, chronic infections, significant acute infections three weeks before or during the study, connective tissue disease, arthritis, chronic pulmonary disease or serious liver- or kidney-disease).
- Simultaneous involvement in other clinical studies involving intervention.
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 |
|---|---|---|
| KrillEncapsulated oil from the antarctic crustacean Krill | Dietary supplement | Krill |
| Fish oilEncapsulated, raffined cod-oil | Dietary supplement | Fish oil |
Primary outcome
Inflammatory blood status
Time frame: 8 weeks intervention
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 6 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Krill and Fish oil in people with Stable Atherosclerotic Coronary Disease, run by Oslo University Hospital at 1 site in Norway.
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 4 inclusion and 6 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 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Inflammatory blood status (time frame: 8 weeks intervention). 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 6 Dec 2023.