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

Study Overview
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Brief Summary
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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.

Official Title
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A Double-blind, Randomized, Multi-centre, Placebo-controlled Study to Investigate the Effects of Superba(TM) Krill Oil on Fasting Serum Triglycerides

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Krill Oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting serum triglycerides |  | Baseline (Day 1) and at Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Omega-3 index |  | At Days 1, 42, and 85 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maintenance of normal blood triglyceride levels