NCT02053415

Brief Summary

The purpose of this study is to examine whether 4 weeks daily intake of krill oil can change the omega-3 index (content of the long chained fatty acids EPA and DHA in relation to the total fatty acids) in the membrane in red blood cells. We investigate this at two different doses. Furthermore, the purpose of the study is also to examine the effect of the krill oil intake on plasma lipids (triacylglycerol, phospholipids and cholesterol), plasma fatty acid composition, as well as product tolerance in healthy, young individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 14, 2014

Status Verified

March 1, 2014

Enrollment Period

2 months

First QC Date

January 31, 2014

Last Update Submit

March 13, 2014

Conditions

Healthy

Keywords

krill oilomega-3 indexplasma lipid profiletoleranceyoung adults

Outcome Measures

Primary Outcomes (1)

  • Fatty acid composition in red blood cells (the membrane)

    Change in fatty acid composition and omega-3 index (sum of % EPA and DHA)

    Day 0 (baseline), and day 28 (end)

Secondary Outcomes (4)

  • Fasting plasma lipid status

    Day o (baseline), and day 28 (end)

  • Fatty acid composition in plasma.

    Day 0 (baseline), and day 28 (end)

  • Fasting glucose and glucose tolerance.

    Day 0 (baseline), and day 28 (end)

  • Tolerance of and compliance with intervention

    Day 28 (end)

Study Arms (2)

Krill oil low dose

EXPERIMENTAL

3 capsules krill oil per day, for 28 days

Dietary Supplement: Krill oil low dose

Krill oil high dose

EXPERIMENTAL

9 capsules krill oil per day, for 28 days

Dietary Supplement: Krill oil high dose

Interventions

Krill oil low doseDIETARY_SUPPLEMENT

3 capsules krill oil per day

Also known as: Rimfrost Sublime krill oil
Krill oil low dose
Krill oil high doseDIETARY_SUPPLEMENT

9 capsules krill oil per day

Also known as: Rimfrost Sublime krill oil
Krill oil high dose

Eligibility Criteria

Age18 Years - 36 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young adults

You may not qualify if:

  • Disease/illness
  • Not able to swallow supplements in capsule form
  • Not willing to take blood samples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Science, University of Bergen

Bergen, Bergen, 5020, Norway

Location

Study Officials

  • Per Bakke, Professor

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 31, 2014

First Posted

February 3, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 14, 2014

Record last verified: 2014-03

Locations

NO(1)