Krill Oil as Supplementation to Healthy Young Adults.

March 13, 2014 updated by: Bodil Bjørndal, University of Bergen

Study of the Effect of Krill Oil Supplement on Omega-3 Fatty Acid Index and Tolerance

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5020
        • Department of Clinical Science, University of Bergen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 34 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy young adults

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Krill oil low dose
3 capsules krill oil per day, for 28 days
Dietary supplement: Krill oil low dose
3 capsules krill oil per day
Other Names:
  • Rimfrost Sublime krill oil
Experimental: Krill oil high dose
9 capsules krill oil per day, for 28 days
Dietary supplement: Krill oil high dose
9 capsules krill oil per day
Other Names:
  • Rimfrost Sublime krill oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatty acid composition in red blood cells (the membrane)
Time Frame: Day 0 (baseline), and day 28 (end)
Change in fatty acid composition and omega-3 index (sum of % EPA and DHA)
Day 0 (baseline), and day 28 (end)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting plasma lipid status
Time Frame: Day o (baseline), and day 28 (end)
  • Change in triacylglycerol levels.
  • Change in phospholipid levels.
  • Change in cholesterol levels (total, ester, free, HDL, LDL).
Day o (baseline), and day 28 (end)
Fatty acid composition in plasma.
Time Frame: Day 0 (baseline), and day 28 (end)
Change in fatty acid composition and omega-3 index (sum of % EPA and DHA).
Day 0 (baseline), and day 28 (end)
Fasting glucose and glucose tolerance.
Time Frame: Day 0 (baseline), and day 28 (end)
Change in fasting glucose and glucose tolerance.
Day 0 (baseline), and day 28 (end)
Tolerance of and compliance with intervention
Time Frame: Day 28 (end)
Questionnaire-based
Day 28 (end)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Collaborators

Olympic Seafood AS

Investigators

  • Principal Investigator: Per Bakke, Professor, University of Bergen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

January 31, 2014

First Submitted That Met QC Criteria

January 31, 2014

First Posted (Estimate)

February 3, 2014

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

March 13, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Krill oil pilot-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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