Bioavailability of Fatty Acids From Krill Oil and Krill Meal and Fatty Acids From Fish Oil in Healthy Subjects.

Study Overview
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Brief Summary
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The purpose of the study is to compare the acute bioavailability of two different krill oil products called krill oil and krill meal in comparison to fish oil product.

Official Title
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Randomized, Single-center, Open-label, Blinded Endpoint Assessment Study (Cross-over Study With 3 Study Products) on Bioavailability of Fatty Acids (Plasma Lipid Fractions) From Krill Oil and Krill Meal and Fatty Acids From Fish Oil in Healthy Subjects.

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Krill oil
* Dietary Supplement: Krill meal
* Dietary Supplement: Fish oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female and male Age 18 - 65 years Body mass index 18.5 - 30 Informed consent, signed Exclusion Criteria: Medication potential to affect the bioavailability of fatty acids (e.g. lipid-lowering drugs) Familial hypercholesterolemia, marked combined hyperlipidemia, condition that would impair, fat absorption (e.g. chronic pancreatitis, pancreatic lipase deficiency syndrome) Any untreated medical condition affecting absorption of fat Type 1 and 2 diabetes Cancer or other malignant disease within past five years Periodical hormone replacement therapy High intake of oily fish (once a week or more) (i.e. salmon, herring, sardines, mackerel, vendace) Smoking Alcohol consumption > 15 doses per week Females who are pregnant, breast-feeding or intend to become pregnant Hypersensitivity to any of the components of the test product Regular use of n-3 supplements 4 weeks before randomization Lack of suitability for participation in the trial, for any medical reason, as judged by the principal investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Krill oil<br>The interventions are administered in the randomized order. | Dietary Supplement: Krill oil<br>* Krill oil from Antarctic krill, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration<br>|
| Experimental: Krill meal<br>The interventions are administered in the randomized order. | Dietary Supplement: Krill meal<br>* Krill meal, granular meal from Antarctic krill, per oral, targeted daily n-3 PUFA dose of 1 700 mg, single administration<br>|
| Active Comparator: Fish oil<br>The interventions are administered in the randomized order. | Dietary Supplement: Fish oil<br>* Fish oil, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma phospholipids. |  | 0-72 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma triglyceride. |  | 0-72 h |