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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
Sponsor:
Collaborator:
Oy Foodfiles Ltd
Information provided by (Responsible Party):
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.

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

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

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




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 ]


Information from the National Library of Medicine

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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
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

Information from the National Library of Medicine

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


Locations
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Finland
Oy Foodfiles Ltd, memeber of Foodfiles group
Kuopio, Finland, 70210
Sponsors and Collaborators
Olympic Seafood AS
Oy Foodfiles Ltd
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Olympic Seafood AS
ClinicalTrials.gov Identifier: NCT02089165     History of Changes
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