Stable Atherosclerotic Coronary Disease Clinical Trial
Official title:
Effect of Superba Krill on Inflammation in Patients With Coronary Artery Disease
| NCT number | NCT01092793 |
| Other study ID # | Krill-2010 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 2010 |
| Est. completion date | January 2012 |
| Verified date | March 2010 |
| Source | Oslo University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | January 2012 |
| Est. primary completion date | January 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Department of Cardiology, Oslo University Hospital / Rikshospitalet | Oslo |
| Lead Sponsor | Collaborator |
|---|---|
| Oslo University Hospital |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Inflammatory blood status | 8 weeks intervention |