NCT02089165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2 healthy

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_2 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 4, 2014

Status Verified

June 1, 2014

Enrollment Period

3 months

First QC Date

March 13, 2014

Last Update Submit

June 3, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

    0-72 h

Secondary Outcomes (1)

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

    0-72 h

Other Outcomes (1)

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

    0-72 h

Study Arms (3)

Krill oil

EXPERIMENTAL

The interventions are administered in the randomized order.

Dietary Supplement: Krill oil

Krill meal

EXPERIMENTAL

The interventions are administered in the randomized order.

Dietary Supplement: Krill meal

Fish oil

ACTIVE COMPARATOR

The interventions are administered in the randomized order.

Dietary Supplement: Fish oil

Interventions

Krill oilDIETARY_SUPPLEMENT

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

Krill oil
Krill mealDIETARY_SUPPLEMENT

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

Krill meal
Fish oilDIETARY_SUPPLEMENT

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

Fish oil

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy female and male
  • Age 18 - 65 years
  • Body mass index 18.5 - 30
  • Informed consent, signed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oy Foodfiles Ltd, memeber of Foodfiles group

Kuopio, 70210, Finland

Location

Related Publications (1)

  • 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.

    PMID: 25884846DERIVED

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Essi S Sarkkinen, Ph.D

    Oy Foodfiles Ltd, member of Foodfiles group

    STUDY DIRECTOR

  • Sakari A Nieminen, MD

    Oy Foodfiles Ltd, memeber of Foodfiles group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 17, 2014

Study Start

February 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 4, 2014

Record last verified: 2014-06

Locations

FI(1)