NCT02568228

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

August 31, 2015

Last Update Submit

November 21, 2016

Conditions

Healthy

Keywords

TriacylglycerolsOmega-3 fatty acidsKrill oilFishHealthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Fasting triglycerides

    8 weeks

Secondary Outcomes (12)

  • Circulating inflammatory markers

    8 weeks

  • Gene expression of inflammatory markers and genes in lipid metabolism

    8 weeks

  • Plasmamlipids

    8 weeks

  • Lipoprotein subclasses

    8 weeks

  • Plasma fatty acid composition

    8 weeks

  • +7 more secondary outcomes

Study Arms (3)

Krill group

EXPERIMENTAL

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

Fish group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Krill oilDIETARY_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.

Also known as: Rimfrost Sublime
Krill group
Lean and fatty fishOTHER

The fish group will be open labeled.

Fish group
Placebo capsulesDIETARY_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.

Control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Stine M Ulven, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2015

First Posted

October 5, 2015

Study Start

August 1, 2015

Primary Completion

November 1, 2016

Last Updated

November 22, 2016

Record last verified: 2016-11