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Effect of Superba Krill on Inflammation in Patients With Coronary Artery Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Oslo University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01092793
First Posted: March 25, 2010
Last Update Posted: March 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oslo University Hospital
  Purpose

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.


Condition Intervention
Stable Atherosclerotic Coronary Disease Dietary Supplement: Krill Dietary Supplement: Fish oil

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (Open Label)
Official Title: Effect of Superba Krill on Inflammation in Patients With Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Inflammatory blood status [ Time Frame: 8 weeks intervention ]

Estimated Enrollment: 60
Study Start Date: February 2010
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Krill Dietary Supplement: Krill
Active Comparator: Fish oil Dietary Supplement: Fish oil
No Intervention: Control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092793


Contacts
Contact: Lars Gullestad, Professor, MD, PhD +47 23070641 Lars.Gullestad@rikshospitalet.no
Contact: Leif Erik Vinge, MD, PhD +47 95970301 leifvi@klinmed.uio.no

Locations
Norway
Department of Cardiology, Oslo University Hospital / Rikshospitalet Recruiting
Oslo, Norway, 0027
Contact: Lars Gullestad, Professor, MD, PhD    +47 23070641    Lars.Gullestad@rikshospitalet.no   
Contact: Leif Erik Vinge, MD, PhD    +47 95970301    leifvie@klinmed.uio.no   
Sponsors and Collaborators
Oslo University Hospital
  More Information

Responsible Party: Lars Gullestad, professor, Dep. of Cardiology, Oslo University Hospital - Rikshospitalet
ClinicalTrials.gov Identifier: NCT01092793     History of Changes
Other Study ID Numbers: Krill-2010
First Submitted: March 23, 2010
First Posted: March 25, 2010
Last Update Posted: March 25, 2010
Last Verified: March 2010

Keywords provided by Oslo University Hospital:
Fish oil
Krill
CAD

Additional relevant MeSH terms:
Inflammation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases