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CompletedNCT01415388Updated Feb 21, 2013

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

An interventional study of Krill Oil in Healthy, sponsored by Aker BioMarine Human Ingredients AS. Completed at 2 sites in United States. Open to participants aged 21 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-21.

Sponsored by Aker BioMarine Human Ingredients AS · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
21 Years to 79 Years
Sex
All
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Study 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.

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Conditions studied

  • Healthy

Keywords

  • Maintenance of normal blood triglyceride levels
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In context

Lead sponsor

Aker BioMarine Human Ingredients AS is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (actual)

Interventions

  • Dietary supplementKrill 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

    Also known as: Superba(TM) Krill Oil

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What researchers measure

Primary outcomes

  1. Change in fasting serum triglycerides

    Time frame: Baseline (Day 1) and at Day 85

Secondary outcomes

  1. Omega-3 index

    Time frame: At Days 1, 42, and 85

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Study locations

2 sites
  • Cetero Research
    St. Charles, Missouri 63301, United States
  • Cetero Research
    Fargo, North Dakota 58104, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01415388
Lead sponsor
Aker BioMarine Human Ingredients AS
Responsible party
Sponsor
First posted
Aug 12, 2011
Start date
Aug 2011
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Feb 21, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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