HealthyPhase 2RISUNCT02089165
Bioavailability of Fatty Acids From Krill Oil and Krill Meal and Fatty Acids From Fish Oil in Healthy Subjects.
A Phase 2 study testing Krill oil, Krill meal and Fish oil in people with Healthy, run by Olympic Seafood AS at 1 site in Finland.
Trial summary
The purpose of the study is to compare the acute bioavailability of two different krill oil products called krill oil and krill meal in comparison to fish oil product. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Krill oil, Krill meal and Fish oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2014to May 2014
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female and male
- Age 18 - 65 years
- Body mass index 18.5 - 30
- Informed consent, signed
Who cannot join
- Medication potential to affect the bioavailability of fatty acids (e.g. lipid-lowering drugs)
- Familial hypercholesterolemia, marked combined hyperlipidemia, condition that would impair, fat absorption (e.g. chronic pancreatitis, pancreatic lipase deficiency syndrome)
- Any untreated medical condition affecting absorption of fat
- Type 1 and 2 diabetes
- Cancer or other malignant disease within past five years
- Periodical hormone replacement therapy
Show all 13Show fewer
- High intake of oily fish (once a week or more) (i.e. salmon, herring, sardines, mackerel, vendace)
- Smoking
- Alcohol consumption > 15 doses per week
- Females who are pregnant, breast-feeding or intend to become pregnant
- Hypersensitivity to any of the components of the test product
- Regular use of n-3 supplements 4 weeks before randomization
- Lack of suitability for participation in the trial, for any medical reason, as judged by the principal investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Single-center, Open-label, Blinded Endpoint Assessment Study (Cross-over Study With 3 Study Products) on Bioavailability of Fatty Acids (Plasma Lipid Fractions) From Krill Oil and Krill Meal and Fatty Acids From Fish Oil in Healthy Subjects.
The purpose of the study is to compare the acute bioavailability of two different krill oil products called krill oil and krill meal in comparison to fish oil product.
- Conditions
- Healthy
- Being tested
- Krill oil, Krill meal, Fish oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Krill oilDietary supplement
Krill oil from Antarctic krill, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration
Krill mealDietary supplement
Krill meal, granular meal from Antarctic krill, per oral, targeted daily n-3 PUFA dose of 1 700 mg, single administration
Fish oilDietary supplement
Fish oil, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration
| Study group | Role | What they receive |
|---|---|---|
| Krill oil | Experimental | The interventions are administered in the randomized order. Receives: Dietary Supplement: Krill oil |
| Krill meal | Experimental | The interventions are administered in the randomized order. Receives: Dietary Supplement: Krill meal |
| Fish oil | Active comparator | The interventions are administered in the randomized order. Receives: Dietary Supplement: Fish oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma phospholipids.
Measured: 0-72 h
Secondary outcomes (1)
Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma triglyceride.
Measured: 0-72 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympic Seafood AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oy Foodfiles Ltd
- Responsible party
- Sponsor
- Investigators
- Essi S Sarkkinen, Ph.D, Study director, Oy Foodfiles Ltd, member of Foodfiles groupSakari A Nieminen, MD, Principal investigator, Oy Foodfiles Ltd, memeber of Foodfiles group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089165
- Sponsor's protocol ID
- RISU 58/2013
- Acronym
- RISU
- Status last verified
- Jun 2014
- First submitted
- 13 Mar 2014
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kohler A, Sarkkinen E, Tapola N, Niskanen T, Bruheim I. Bioavailability of fatty acids from krill oil, krill meal and fish oil in healthy subjects--a randomized, single-dose, cross-over trial. Lipids Health Dis. 2015 Mar 15;14:19. doi: 10.1186/s12944-015-0015-4.
PubMed 25884846
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-center, Open-label, Blinded Endpoint Assessment Study (Cross-over Study With 3 Study Products) on Bioavailability of Fatty Acids (Plasma Lipid Fractions) From Krill Oil and Krill Meal and Fatty Acids From Fish Oil in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT02089165
- Acronym / sponsor ID
- RISU / RISU 58/2013
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Olympic Seafood ASIndustry (pharma, biotech, devices)
- Collaborators
- Oy Foodfiles Ltd
- Study start
- Feb 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Mar 2014 (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.
The purpose of the study is to compare the acute bioavailability of two different krill oil products called krill oil and krill meal in comparison to fish oil product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Krill oil | Experimental | Dietary Supplement: Krill oilThe interventions are administered in the randomized order. |
| Krill meal | Experimental | Dietary Supplement: Krill mealThe interventions are administered in the randomized order. |
| Fish oil | Active comparator | Dietary Supplement: Fish oilThe interventions are administered in the randomized order. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy female and male
- Age 18 - 65 years
- Body mass index 18.5 - 30
- Informed consent, signed
Key exclusion criteria (13 listed)
- Medication potential to affect the bioavailability of fatty acids (e.g. lipid-lowering drugs)
- Familial hypercholesterolemia, marked combined hyperlipidemia, condition that would impair, fat absorption (e.g. chronic pancreatitis, pancreatic lipase deficiency syndrome)
- Any untreated medical condition affecting absorption of fat
- Type 1 and 2 diabetes
- Cancer or other malignant disease within past five years
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 oilKrill oil from Antarctic krill, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration | Dietary supplement | Krill oil |
| Krill mealKrill meal, granular meal from Antarctic krill, per oral, targeted daily n-3 PUFA dose of 1 700 mg, single administration | Dietary supplement | Krill meal |
| Fish oilFish oil, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration | Dietary supplement | Fish oil |
Primary outcome
Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma phospholipids.
Time frame: 0-72 h
1 secondary outcome
Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma triglyceride.
Time frame: 0-72 h
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 4 Jun 2014.
- Derived from this study: PubMed 25884846Kohler A, Sarkkinen E, Tapola N, Niskanen T, Bruheim I. Bioavailability of fatty acids from krill oil, krill meal and fish oil in healthy subjects--a randomized, single-dose, cross-over trial. Lipids Health Dis. 2015 Mar 15;14:19. doi: 10.1186/s12944-015-0015-4.
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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.
Essi S Sarkkinen, Ph.D study director
Oy Foodfiles Ltd, member of Foodfiles group
Sakari A Nieminen, MD principal investigator
Oy Foodfiles Ltd, memeber of Foodfiles group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Krill oil, Krill meal and Fish oil in people with Healthy, run by Olympic Seafood AS at 1 site in Finland.
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 4 inclusion and 13 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 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma phospholipids. (time frame: 0-72 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02089165, which also lists 1 linked publication.
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 4 Jun 2014.