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

Phase 2

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Krill oil; Dietary Supplement: Krill meal; Dietary Supplement: Fish oil

• Registration Number: NCT02089165
• Lead Sponsor: Olympic Seafood AS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-17
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Krill oil	Krill oil	The interventions are administered in the randomized order.
Krill meal	Krill meal	The interventions are administered in the randomized order.
Fish oil	Fish oil	The interventions are administered in the randomized order.

Primary Outcome Measures

Name	Time	Method
Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma phospholipids.	0-72 h

Secondary Outcome Measures

Name	Time	Method
Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma triglyceride.	0-72 h

Trial Locations

Locations (1)

Oy Foodfiles Ltd, memeber of Foodfiles group; 🇫🇮 Kuopio, Finland