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Study to Investigate the Effects of Krill Oil on Fasting Serum Triglycerides

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. Identifier: NCT01415388
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : February 21, 2013
Information provided by (Responsible Party):
Aker Biomarine Antarctic AS

Brief Summary:
The purpose of this study is to assess the effect of 12 weeks of daily supplementation with Superba(TM) Krill Oil on fasting serum triglyceride levels and omega-3 index in subjects whose habitual fatty fish and seafood intake is low and who have borderline high or high fasting serum triglyceride levels.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Krill Oil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Double-blind, Randomized, Multi-centre, Placebo-controlled Study to Investigate the Effects of Superba(TM) Krill Oil on Fasting Serum Triglycerides
Study Start Date : August 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Intervention Details:
  • Dietary Supplement: Krill Oil
    4 Capsules twice daily providing 0 (placebo), 0.5, 1.0, 2.0, or 4.0 g krill oil/day for a period of 12 weeks
    Other Name: Superba(TM) Krill Oil

Primary Outcome Measures :
  1. Change in fasting serum triglycerides [ Time Frame: Baseline (Day 1) and at Day 85 ]

Secondary Outcome Measures :
  1. Omega-3 index [ Time Frame: At Days 1, 42, and 85 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria(not limited to):

  • General good health with no existing co-morbidities
  • Body mass index (BMI) less than 35 kg/m²
  • Borderline high or high fasting serum triglycerides
  • Clinically normal findings for hematology, clinical chemistry, and urinalysis
  • Be willing to maintain dietary habits and physical activity levels throughout the trial period (next 4 months)
  • Have a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less

Exclusion Criteria (not limited to):

  • Familial hypercholesterolemia or severely high total cholesterol levels
  • History or presence of significant cardiovascular disease or co-morbidities
  • Known allergy to crustaceans (shellfish)
  • Bleeding disorders
  • Disturbed absorption due to changes in the gastrointestinal tract
  • Participation in a clinical trial with an investigational product within 30 days before screening
  • Present or recent use (within 3 months of screening or the first screening visit, if applicable) of any medication which is a known lipid modifying agent or any dietary supplements that affect the level of blood cholesterol and triglycerides
  • Current or recent diet, which in the opinion of the Investigator, deviates from a normal diet (e.g., vegetarians may be acceptable, vegans are not acceptable)
  • Female patients that are pregnant or nursing or females of childbearing potential who are not on a method of birth control acceptable to the Investigator during treatment
  • Patients with known coagulopathy or receiving anticoagulant therapy or co-morbidity that would interfere with the study results
  • Frequency of fatty fish and/or seafood consumption is greater than twice per month
  • Present or recent use of any long-chain omega-3 fatty acid supplement
  • Peri-menopausal women or post-menopausal women taking hormone replacement therapy
  • Patients who test positive for human immunodeficiency virus (HIV) or hepatitis B or C
  • Systolic blood pressure greater than 159 mmHg or diastolic blood pressure greater than 99 mmHg or use of anti-hypertensive medication
  • Diabetic subjects
  • Staff of Cetero Research

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 identifier (NCT number): NCT01415388

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United States, Missouri
Cetero Research
St. Charles, Missouri, United States, 63301
United States, North Dakota
Cetero Research
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Aker Biomarine Antarctic AS
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Responsible Party: Aker Biomarine Antarctic AS Identifier: NCT01415388    
Other Study ID Numbers: CHSI 1102-16
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013
Keywords provided by Aker Biomarine Antarctic AS:
Maintenance of normal blood triglyceride levels