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

• ClinicalTrials.gov Identifier: NCT02089165
• Recruitment Status: Completed
• First Posted: March 17, 2014
• Last Update Posted: June 4, 2014
• Sponsor: Olympic Seafood AS
• Collaborator: Oy Foodfiles Ltd
• Information provided by (Responsible Party): Olympic Seafood AS

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Dietary Supplement: Krill oil; Dietary Supplement: Krill meal; Dietary Supplement: Fish oil	Phase 2

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Krill oil; The interventions are administered in the randomized order.	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

Outcome Measures

Primary Outcome Measures :

1. Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma phospholipids. [ Time Frame: 0-72 h ]

Secondary Outcome Measures :

1. Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma triglyceride. [ Time Frame: 0-72 h ]

Other Outcome Measures:

1. Mean proportions of fatty acids in plasma phospholipids and triglycerides. [ Time Frame: 0-72 h ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Finland

Oy Foodfiles Ltd, memeber of Foodfiles group

Kuopio, Finland, 70210

Sponsors and Collaborators

Olympic Seafood AS

Oy Foodfiles Ltd

Investigators

• 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Olympic Seafood AS
• ClinicalTrials.gov Identifier: NCT02089165
• Other Study ID Numbers: RISU 58/2013
• First Posted: March 17, 2014
• Last Update Posted: June 4, 2014
• Last Verified: June 2014