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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aker Biomarine Antarctic AS
ClinicalTrials.gov Identifier:
NCT01415388
First received: August 10, 2011
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Healthy
 Dietary Supplement: Krill Oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Aker Biomarine Antarctic AS:

Primary Outcome Measures:
  • Change in fasting serum triglycerides [ Time Frame: Baseline (Day 1) and at Day 85 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Omega-3 index [ Time Frame: At Days 1, 42, and 85 ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: August 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   21 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415388

Locations
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
  More Information

No publications provided

Responsible Party: Aker Biomarine Antarctic AS
ClinicalTrials.gov Identifier: NCT01415388     History of Changes
Other Study ID Numbers: CHSI 1102-16
Study First Received: August 10, 2011
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Aker Biomarine Antarctic AS:
Maintenance of normal blood triglyceride levels

ClinicalTrials.gov processed this record on May 16, 2013