Krill Oil as Supplementation to Healthy Young Adults.

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053415
• Other study ID #: Krill oil pilot-2014
• Status: Completed
• Phase: N/A
• First received: January 31, 2014
• Last updated: March 13, 2014
• Start date: January 2014
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 36 Years

Eligibility

Inclusion Criteria:

• Healthy young adults

Exclusion Criteria:

• Disease/illness

• Not able to swallow supplements in capsule form

• Not willing to take blood samples

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Krill oil low dose
3 capsules krill oil per day
• Krill oil high dose
9 capsules krill oil per day

Locations

Country	Name	City	State
Norway	Department of Clinical Science, University of Bergen	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	Olympic Seafood AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Fasting plasma lipid status	Change in triacylglycerol levels.; Change in phospholipid levels.; Change in cholesterol levels (total, ester, free, HDL, LDL).	Day o (baseline), and day 28 (end)	No
Secondary	Fatty acid composition in plasma.	Change in fatty acid composition and omega-3 index (sum of % EPA and DHA).	Day 0 (baseline), and day 28 (end)	No
Secondary	Fasting glucose and glucose tolerance.	Change in fasting glucose and glucose tolerance.	Day 0 (baseline), and day 28 (end)	No
Secondary	Tolerance of and compliance with intervention	Questionnaire-based	Day 28 (end)	No