HealthyNCT02568228
Health Beneficial Effects of Krill Oil and Lean and Fatty Fish
A study testing Krill oil and Lean and fatty fish in people with Healthy, run by Oslo Metropolitan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Krill oil and Lean and fatty fish
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
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
- Being tested
- Krill oil, Lean and fatty fish, Placebo capsules
- Keywords
- Triacylglycerols, Omega-3 fatty acids, Krill oil, Fish, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Krill oilDietary supplement
Also called Rimfrost Sublime
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.
Lean and fatty fishOther
The fish group will be open labeled.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting triglycerides
Measured: 8 weeks
Secondary outcomes (12)
Circulating inflammatory markers
Such as TNFalpha and IL-6
Measured: 8 weeks
Gene expression of inflammatory markers and genes in lipid metabolism
Measured with RT-qPCR
Measured: 8 weeks
Plasmamlipids
Such as total- LDL- and HDL-cholesterol
Measured: 8 weeks
Lipoprotein subclasses
Measured: 8 weeks
Plasma fatty acid composition
Measured: 8 weeks
Blood pressure
Measured: 8 weeks
Endothelial dysfunction markers
Sush as NOx and ADMA
Measured: 8 weeks
Hemostatic markers
Such as vWF and thrombomudulin
Measured: 8 weeks
Muscle strength
Measured by hand grip strength and chair stand test
Measured: 8 weeks
Whole genome transcriptome analysis in PBMC
Changes in the gene expression profile
Measured: 8 weeks
Metabolome profile in blood
In blood
Measured: 8 weeks
Metabolome profile in urine
In urine
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Olympic Seafood AS
- Responsible party
- Sponsor
- Investigators
- Stine M Ulven, PhD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568228
- Sponsor's protocol ID
- 2015/706/REK sør-øst C
- Status last verified
- Nov 2016
- First submitted
- 31 Aug 2015
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Beneficial Effects of Krill Oil and Lean and Fatty Fish
- ClinicalTrials.gov ID
- NCT02568228
- Acronym / sponsor ID
- 2015/706/REK sør-øst C
- Conditions
- Healthy
- Keywords
- Triacylglycerols, Omega-3 fatty acids, Krill oil, Fish, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- University of Oslo, Olympic Seafood AS
- Study start
- Aug 2015
- Primary completion
- Nov 2016 (actual)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Krill group | Experimental | Dietary Supplement: Krill oilKrill 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. |
| Fish group | Experimental | Other: Lean and fatty fishLean 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. |
| Control group | Placebo comparator | Dietary Supplement: Placebo capsulesPlacebo 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Krill oilAlso: Rimfrost SublimeThe 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. | Dietary supplement | Krill group |
| Lean and fatty fishThe fish group will be open labeled. | Other | Fish group |
| Placebo capsulesThe 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. | Dietary supplement | Control group |
Primary outcome
Fasting triglycerides
Time frame: 8 weeks
12 secondary outcomes
Circulating inflammatory markers
Time frame: 8 weeks
Gene expression of inflammatory markers and genes in lipid metabolism
Time frame: 8 weeks
Plasmamlipids
Time frame: 8 weeks
Lipoprotein subclasses
Time frame: 8 weeks
Plasma fatty acid composition
Time frame: 8 weeks
Blood pressure
Time frame: 8 weeks
Endothelial dysfunction markers
Time frame: 8 weeks
Hemostatic markers
Time frame: 8 weeks
Muscle strength
Time frame: 8 weeks
Whole genome transcriptome analysis in PBMC
Time frame: 8 weeks
Metabolome profile in blood
Time frame: 8 weeks
Metabolome profile in urine
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stine M Ulven, PhD principal investigator
University of Oslo
Questions about this trial
What is this clinical trial studying?
A study testing Krill oil and Lean and fatty fish in people with Healthy, run by Oslo Metropolitan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting triglycerides (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.