A Parallel Bioavailability Study of Fish Oil-Ethyl Ester Versus Fish Oil-Triglyceride Versus Krill Oil

Study Overview
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Brief Summary
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A multiple-dose, double-blind, randomized, four-week, three-treatment, parallel study in which 66 healthy adult subjects will receive 6 capsules/d, administered as a dose of 1.3 g/d eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) in fish oil ethyl ester (EE), or fish oil triglyceride (TG) or krill oil for a total of 4 weeks. The objective of the study is to compare the oral bioavailability of EPA+DHA in total plasma across the three formulations at the end of the 4 week study.

Official Title
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A Parallel Bioavailability Study of Fish Oil-Ethyl Ester Versus Fish Oil-Triglyceride Versus Krill Oil

Conditions
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Healthy Adults

Intervention / Treatment
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* Dietary Supplement: fish oil ethyl ester
* Dietary Supplement: fish oil triglyceride
* Dietary Supplement: krill oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, adult female who is neither pregnant nor breastfeeding, or a healthy, adult male with a body mass index (BMI) between 18 and 30 kg/m2 (inclusive), and with a minimum weight of 50 kg (110 lbs). Exclusion Criteria: history or presence of diabetes, high triglycerides (≥240 mg/dL), or high cholesterol (≥240 mg/dL); clinically significant abnormal finding on the physical exam, medical history, vital signs, or clinical laboratory results at screening; history or presence of allergic response to omega-3-fatty acids or sensitivity or allergy to fish or shellfish; history of coagulation disorder or current anticoagulation therapy; has used any nutritional supplements, omega-3 supplements, fish oil, chia, krill oil, flaxseed or foods supplemented with omega-3s within 3 months prior to the first dose of study medication; has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fish oil ethyl ester<br>1.3g/d dose of DHA+EPA in fish oil EE (6 capsules) administered for 4 weeks | Dietary Supplement: fish oil ethyl ester<br> <br> |
| Active Comparator: fish oil triglyceride<br>1.3g/d dose of DHA+EPA in fish oil TG (6 capsules) administered for 4 weeks | Dietary Supplement: fish oil triglyceride<br> <br> |
| Active Comparator: krill oil<br>1.3g/d dose of DHA+EPA in krill oil (6 capsules) administered for 4 weeks | Dietary Supplement: krill oil<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of total plasma DHA+EPA levels across 3 treatment groups |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of RBC DHA+EPA levels across 3 treatment groups |  | 4 weeks | 
| pharmacokinetic parameter: AUC to 672hr |  | 4 weeks | 
| pharmacokinetic parameter: AUC to 336hr |  | 2 weeks | 
| pharmacokinetic parameter: Cmax |  | 4 weeks | 
| pharmacokinetic parameter: Tmax |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioavailability, fish oil, krill oil