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Health Beneficial Effects of Krill Oil and Lean and Fatty Fish

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568228
Recruitment Status : Completed
First Posted : October 5, 2015
Last Update Posted : November 22, 2016
Sponsor:
Collaborators:
University of Oslo
Olympic Seafood AS
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Krill oil Other: Lean and fatty fish Dietary Supplement: Placebo capsules Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Health Beneficial Effects of Krill Oil and Lean and Fatty Fish
Study Start Date : August 2015
Actual Primary Completion Date : November 2016

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 Name: 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.




Primary Outcome Measures :
  1. Fasting triglycerides [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Circulating inflammatory markers [ Time Frame: 8 weeks ]
    Such as TNFalpha and IL-6

  2. Gene expression of inflammatory markers and genes in lipid metabolism [ Time Frame: 8 weeks ]
    Measured with RT-qPCR

  3. Plasmamlipids [ Time Frame: 8 weeks ]
    Such as total- LDL- and HDL-cholesterol

  4. Lipoprotein subclasses [ Time Frame: 8 weeks ]
  5. Plasma fatty acid composition [ Time Frame: 8 weeks ]
  6. Blood pressure [ Time Frame: 8 weeks ]
  7. Endothelial dysfunction markers [ Time Frame: 8 weeks ]
    Sush as NOx and ADMA

  8. Hemostatic markers [ Time Frame: 8 weeks ]
    Such as vWF and thrombomudulin

  9. Muscle strength [ Time Frame: 8 weeks ]
    Measured by hand grip strength and chair stand test

  10. Whole genome transcriptome analysis in PBMC [ Time Frame: 8 weeks ]
    Changes in the gene expression profile

  11. Metabolome profile in blood [ Time Frame: 8 weeks ]
    In blood

  12. Metabolome profile in urine [ Time Frame: 8 weeks ]
    In urine



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568228


Sponsors and Collaborators
Oslo Metropolitan University
University of Oslo
Olympic Seafood AS
Investigators
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Principal Investigator: Stine M Ulven, PhD University of Oslo
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Responsible Party: Oslo Metropolitan University
ClinicalTrials.gov Identifier: NCT02568228    
Other Study ID Numbers: 2015/706/REK sør-øst C
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Keywords provided by Oslo Metropolitan University:
Triacylglycerols
Omega-3 fatty acids
Krill oil
Fish
Healthy Volunteers