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

Healthy Clinical Trial

— RISU  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089165
• Other study ID #: RISU 58/2013
• Status: Completed
• Phase: Phase 2
• First received: March 13, 2014
• Last updated: June 3, 2014
• Start date: February 2014
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Olympic Seafood AS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Krill oil
Krill oil from Antarctic krill, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration
• Krill meal
Krill meal, granular meal from Antarctic krill, per oral, targeted daily n-3 PUFA dose of 1 700 mg, single administration
• Fish oil
Fish oil, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration

Locations

Country	Name	City	State
Finland	Oy Foodfiles Ltd, memeber of Foodfiles group	Kuopio

Sponsors (2)

Lead Sponsor	Collaborator
Olympic Seafood AS	Oy Foodfiles Ltd

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean proportions of fatty acids in plasma phospholipids and triglycerides.		0-72 h	No
Primary	Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma phospholipids.		0-72 h	No
Secondary	Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma triglyceride.		0-72 h	No