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

Aker Biomarine

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Krill Oil

Study type

Interventional

Funder types

Industry

Identifiers

NCT01415388

CHSI 1102-16

Details and patient eligibility

About

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.

Enrollment

300 patients

Sex

All

Ages

21 to 79 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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