Health Beneficial Effects of Krill Oil and Lean and Fatty Fish

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Krill oil; Other: Lean and fatty fish; Dietary Supplement: Placebo capsules

• Registration Number: NCT02568228
• Lead Sponsor: Oslo Metropolitan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-05
• Status Verified: 2016-11
• Primary Completion: 2016-11
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Krill group	Krill oil	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.
Fish group	Lean and fatty fish	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.
Control group	Placebo capsules	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.

Primary Outcome Measures

Name	Time	Method
Fasting triglycerides	8 weeks

Secondary Outcome Measures

Name	Time	Method
Hemostatic markers	8 weeks	Such as vWF and thrombomudulin
Circulating inflammatory markers	8 weeks	Such as TNFalpha and IL-6
Gene expression of inflammatory markers and genes in lipid metabolism	8 weeks	Measured with RT-qPCR
Plasmamlipids	8 weeks	Such as total- LDL- and HDL-cholesterol
Lipoprotein subclasses	8 weeks
Plasma fatty acid composition	8 weeks
Blood pressure	8 weeks
Endothelial dysfunction markers	8 weeks	Sush as NOx and ADMA
Muscle strength	8 weeks	Measured by hand grip strength and chair stand test
Whole genome transcriptome analysis in PBMC	8 weeks	Changes in the gene expression profile
Metabolome profile in blood	8 weeks	In blood
Metabolome profile in urine	8 weeks	In urine