Clinical trial NCT02568228: Health Beneficial Effects of Krill Oil and Lean and Fatty Fish
Official title: Health Beneficial Effects of Krill Oil and Lean and Fatty Fish
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Triacylglycerols
Omega-3 fatty acids
Krill oil
Fish
Healthy Volunteers
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Olympic Seafood AS
First posted: 2015-10-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Fasting triglycerides
timeFrame: 8 weeks
Secondary outcomes:
measure: Circulating inflammatory markers
timeFrame: 8 weeks
measure: Gene expression of inflammatory markers and genes in lipid metabolism
timeFrame: 8 weeks
measure: Plasmamlipids
timeFrame: 8 weeks
measure: Lipoprotein subclasses
timeFrame: 8 weeks
measure: Plasma fatty acid composition
timeFrame: 8 weeks
measure: Blood pressure
timeFrame: 8 weeks
measure: Endothelial dysfunction markers
timeFrame: 8 weeks
measure: Hemostatic markers
timeFrame: 8 weeks
measure: Muscle strength
timeFrame: 8 weeks
measure: Whole genome transcriptome analysis in PBMC
timeFrame: 8 weeks
measure: Metabolome profile in blood
timeFrame: 8 weeks
measure: Metabolome profile in urine
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Oslo
name: Stine M Ulven, PhD
role: PRINCIPAL_INVESTIGATOR
References: