Bioavailability of Fatty Acids From Krill Oil and Krill Meal and Fatty Acids From Fish Oil in Healthy Subjects. (RISU)
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ClinicalTrials.gov Identifier: NCT02089165 |
Recruitment Status :
Completed
First Posted : March 17, 2014
Last Update Posted : June 4, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Dietary Supplement: Krill oil Dietary Supplement: Krill meal Dietary Supplement: Fish oil | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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. |
Study Start Date : | February 2014 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Krill oil
The interventions are administered in the randomized order.
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Dietary Supplement: Krill oil
Krill oil from Antarctic krill, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration |
Experimental: Krill meal
The interventions are administered in the randomized order.
|
Dietary Supplement: Krill meal
Krill meal, granular meal from Antarctic krill, per oral, targeted daily n-3 PUFA dose of 1 700 mg, single administration |
Active Comparator: Fish oil
The interventions are administered in the randomized order.
|
Dietary Supplement: Fish oil
Fish oil, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration |
- Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma phospholipids. [ Time Frame: 0-72 h ]
- Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma triglyceride. [ Time Frame: 0-72 h ]
- Mean proportions of fatty acids in plasma phospholipids and triglycerides. [ Time Frame: 0-72 h ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089165
Finland | |
Oy Foodfiles Ltd, memeber of Foodfiles group | |
Kuopio, Finland, 70210 |
Study Director: | Essi S Sarkkinen, Ph.D | Oy Foodfiles Ltd, member of Foodfiles group | |
Principal Investigator: | Sakari A Nieminen, MD | Oy Foodfiles Ltd, memeber of Foodfiles group |
Responsible Party: | Olympic Seafood AS |
ClinicalTrials.gov Identifier: | NCT02089165 |
Other Study ID Numbers: |
RISU 58/2013 |
First Posted: | March 17, 2014 Key Record Dates |
Last Update Posted: | June 4, 2014 |
Last Verified: | June 2014 |