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

NCT ID: NCT02089165

Last Updated: 2014-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-05-31

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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Krill oil

The interventions are administered in the randomized order.

Group Type EXPERIMENTAL

Krill oil

Intervention Type DIETARY_SUPPLEMENT

Krill oil from Antarctic krill, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration

Krill meal

The interventions are administered in the randomized order.

Group Type EXPERIMENTAL

Krill meal

Intervention Type DIETARY_SUPPLEMENT

Krill meal, granular meal from Antarctic krill, per oral, targeted daily n-3 PUFA dose of 1 700 mg, single administration

Fish oil

The interventions are administered in the randomized order.

Group Type ACTIVE_COMPARATOR

Fish oil

Intervention Type DIETARY_SUPPLEMENT

Fish oil, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration

Interventions

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Krill oil

Krill oil from Antarctic krill, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Fish oil

Fish oil, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oy Foodfiles Ltd

OTHER

Sponsor Role collaborator

Olympic Seafood AS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Essi S Sarkkinen, Ph.D

Role: STUDY_DIRECTOR

Oy Foodfiles Ltd, member of Foodfiles group

Sakari A Nieminen, MD

Role: PRINCIPAL_INVESTIGATOR

Oy Foodfiles Ltd, memeber of Foodfiles group

Locations

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Oy Foodfiles Ltd, memeber of Foodfiles group

Kuopio, , Finland

Site Status

Countries

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Finland

References

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Kohler A, Sarkkinen E, Tapola N, Niskanen T, Bruheim I. Bioavailability of fatty acids from krill oil, krill meal and fish oil in healthy subjects--a randomized, single-dose, cross-over trial. Lipids Health Dis. 2015 Mar 15;14:19. doi: 10.1186/s12944-015-0015-4.

Reference Type DERIVED
PMID: 25884846 (View on PubMed)

Other Identifiers

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RISU 58/2013

Identifier Type: -

Identifier Source: org_study_id

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