Status:
COMPLETED
Study to Investigate the Effects of Krill Oil on Fasting Serum Triglycerides
Lead Sponsor:
Aker BioMarine Human Ingredients AS
Conditions:
Healthy
Eligibility:
All Genders
21-79 years
Phase:
NA
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 fatt...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01415388
Start Date
August 1 2011
End Date
September 1 2012
Last Update
February 21 2013
Active Locations (2)
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1
Cetero Research
Saint Charles, Missouri, United States, 63301
2
Cetero Research
Fargo, North Dakota, United States, 58104