Health Beneficial Effects of Krill Oil and Lean and Fatty Fish

NCT ID: NCT02568228

Last Updated: 2016-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31

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.

Conditions

Healthy

Keywords

Triacylglycerols; Omega-3 fatty acids; Krill oil; Fish; Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Krill oil

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Lean and fatty fish

Intervention Type: OTHER

The fish group will be open labeled.

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.

Group Type: PLACEBO_COMPARATOR

Placebo capsules

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Lean and fatty fish

The fish group will be open labeled.

Intervention Type: OTHER

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Rimfrost Sublime

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Olympic Seafood AS

INDUSTRY

Sponsor Role: collaborator

Oslo Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stine M Ulven, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Other Identifiers

2015/706/REK sør-øst C

Identifier Type: -

Identifier Source: org_study_id