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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Krill oil; Other: Lean and fatty fish; Dietary supplement: Placebo capsules

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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; The fish group will be open labeled.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fasting triglycerides	8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oslo Metropolitan University
• Collaborators: University of Oslo; Olympic Seafood AS
• Investigators: Principal Investigator: Stine M Ulven, PhD, University of Oslo

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: August 31, 2015
• First Submitted That Met QC Criteria: October 2, 2015
• First Posted (Estimate): October 5, 2015

Study Record Updates

• Last Update Posted (Estimate): November 22, 2016
• Last Update Submitted That Met QC Criteria: November 21, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Omega-3 fatty acids; Fish; Triacylglycerols; Krill oil
• Other Study ID Numbers: 2015/706/REK sør-øst C