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NCT Number: NCT02568228

Health Beneficial Effects of Krill Oil and Lean and Fatty Fish

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.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Krill oil

Dietary Supplement

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.

Other names: Rimfrost Sublime

Lean and fatty fish

Other

The fish group will be open labeled.

Placebo capsules

Dietary Supplement

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.

Primary outcomes

  1. Fasting triglycerides

    Time frame: 8 weeks

Secondary outcomes

  1. Circulating inflammatory markers

    Time frame: 8 weeks

    Such as TNFalpha and IL-6

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

    Time frame: 8 weeks

    Measured with RT-qPCR

  3. Plasmamlipids

    Time frame: 8 weeks

    Such as total- LDL- and HDL-cholesterol

  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

    Time frame: 8 weeks

    Sush as NOx and ADMA

  8. Hemostatic markers

    Time frame: 8 weeks

    Such as vWF and thrombomudulin

  9. Muscle strength

    Time frame: 8 weeks

    Measured by hand grip strength and chair stand test

  10. Whole genome transcriptome analysis in PBMC

    Time frame: 8 weeks

    Changes in the gene expression profile

  11. Metabolome profile in blood

    Time frame: 8 weeks

    In blood

  12. Metabolome profile in urine

    Time frame: 8 weeks

    In urine

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Collaborators

  • Olympic Seafood AS
  • University of Oslo

Registry information

Important dates

Study start
2015
Primary completion
2016
First posted
Oct 5, 2015
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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