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CompletedNCT02568228Updated Nov 22, 2016

Health Beneficial Effects of Krill Oil and Lean and Fatty Fish

An interventional study of Krill oil and Lean and fatty fish in Healthy, sponsored by Oslo Metropolitan University. Completed. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-22.

Sponsored by Oslo Metropolitan University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Intake of omega-3 (n-3) polyunsaturated fatty acids (PUFAs) from fish oil and fish are associated with significant health benefits in risk of cardiovascular disease. However, both lean and fatty fish have been shown to have beneficial effects suggesting that not all effects are mediated by n-3 PUFAs. Krill oil is an n-3 PUFA supplement on the marked. The n-3 PUFAs from krill oil is in the form of phospholipids, and these fatty acids may be more readily and effectively absorbed after ingestion than n-3 PUFAs in the form of triacylglycerols from fish oil. Fish also contain many other potential health components than n-3 PUFAs such as taurine and vitamin D, iodine, selenium and more unspecified components such as bioactive peptides which can mediate the health beneficial effects observed after intake of fish.

The present study aims to elucidate the cardiovascular health beneficial effects after consumption of fish (lean and fatty) and krill oil, with regard to effects on plasma lipids and other markers of cardiovascular health such as inflammatory, haemostatic and endothelial dysfunction markers. The investigators will perform whole genome transcriptome analyses in peripheral blood mononuclear cells (PBMCs) in order to further understand the cardiovascular health benefits and elucidate the mechanisms of action.

02

Conditions studied

  • Healthy

Keywords

  • Triacylglycerols
  • Omega-3 fatty acids
  • Krill oil
  • Fish
  • Healthy Volunteers
03

In context

Lead sponsor

Oslo Metropolitan University is the lead sponsor of 64 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteers (CRP \< 10 mg/L)
  • Stable weight (± 5 % of body weight) the last three months
  • BMI 18.5-35 kg/m2
  • Fasting triglycerides 1.3-4.0 mmol/L
  • Willingness to eat fish
  • Willingness to not take omega-3 or other dietary supplements during the study.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or lactation
  • Any chronic disease, including diabetes type 1 or 2. CVD or cancer past 6 months
  • Elevated thyroid hormones or TSH levels
  • Elevated total cholesterol (>7.8 mmol/L) or fasting triglycerides (>4.0 mmol/L)
  • Use of prescription drugs that may affect triglycerides (e.g. diabetes drugs, Cyclosporin A, Orlistat and Sibutramine), except statins if stable dose past 3 months.
  • Blood pressure > 160/100 mmHg
  • Hormone treatment (except stable doses the past three months of contraceptives or thyroxine)
  • Planned weight loss
  • The use of Vita Proactive or other food items enriched with plant sterols
  • Excessive alcohol consumption (>40 g/day)
  • Habitual fish consumption of more than one serving of fatty fish per week
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Krill group

    Krill oil capsules. 4 g/day encapsulated krill oil (Rimfrost Sublime) corresponding to \~900 mg/day EPA + DHA + DPA for 8 weeks. The participants will be instructed to take the capsules with the breakfast and dinner meals.

    Dietary Supplement: Krill oil

  • Experimental
    Fish group

    Lean and fatty fish. Three weekly test-meals, containing two meals of fatty fish and one meal of lean fish for 8 weeks corresponding to \~900 mg/day EPA + DHA + DPA.

    Other: Lean and fatty fish

  • Placebo comparator
    Control group

    Placebo capsules. 4 g/day encapsulated high oleic sunflower oil (HOSO) for 8 weeks. The participants will be instructed to take the capsules with the breakfast and dinner meals.

    Dietary Supplement: Placebo capsules

Interventions

  • Dietary supplementKrill oil

    The krill group and the control group will be double blinded. The krill oil and placebo capsules will be administered in equal amounts and are of equal size and have the same color.

    Also known as: Rimfrost Sublime

  • OtherLean and fatty fish

    The fish group will be open labeled.

  • Dietary supplementPlacebo capsules

    The krill group and the control group will be double blinded. The krill oil and placebo capsules will be administered in equal amounts and are of equal size and have the same color.

06

What researchers measure

Primary outcomes

  1. Fasting triglycerides

    Time frame: 8 weeks

Secondary outcomes

  1. Circulating inflammatory markers

    Such as TNFalpha and IL-6

    Time frame: 8 weeks

  2. Gene expression of inflammatory markers and genes in lipid metabolism

    Measured with RT-qPCR

    Time frame: 8 weeks

  3. Plasmamlipids

    Such as total- LDL- and HDL-cholesterol

    Time frame: 8 weeks

  4. Lipoprotein subclasses

    Time frame: 8 weeks

  5. Plasma fatty acid composition

    Time frame: 8 weeks

  6. Blood pressure

    Time frame: 8 weeks

  7. Endothelial dysfunction markers

    Sush as NOx and ADMA

    Time frame: 8 weeks

  8. Hemostatic markers

    Such as vWF and thrombomudulin

    Time frame: 8 weeks

  9. Muscle strength

    Measured by hand grip strength and chair stand test

    Time frame: 8 weeks

  10. Whole genome transcriptome analysis in PBMC

    Changes in the gene expression profile

    Time frame: 8 weeks

  11. Metabolome profile in blood

    In blood

    Time frame: 8 weeks

  12. Metabolome profile in urine

    In urine

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02568228
Lead sponsor
Oslo Metropolitan University
Collaborators
University of Oslo, Olympic Seafood AS
Responsible party
Sponsor
First posted
Oct 5, 2015
Start date
Aug 2015
Primary completion
Nov 2016
Last update
Nov 22, 2016

Study contacts

Stine M Ulven, PhD
principal investigator · University of Oslo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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