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Completed

NCT Number: NCT02089165

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oy Foodfiles Ltd, memeber of Foodfiles group

Kuopio, 70210, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Krill oil

Dietary Supplement

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

Krill meal

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

Dietary Supplement

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

Primary outcomes

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

    Time frame: 0-72 h

Secondary outcomes

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

    Time frame: 0-72 h

Other outcomes

  1. Mean proportions of fatty acids in plasma phospholipids and triglycerides.

    Time frame: 0-72 h

Sponsors and collaborators

Lead sponsor

Olympic Seafood AS

Industry

Collaborators

  • Oy Foodfiles Ltd

Registry information

Official study 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.

Acronym: RISU

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 17, 2014
Registry last updated
Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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