HealthyNCT02053415
Krill Oil as Supplementation to Healthy Young Adults.
A study testing Krill oil low dose and Krill oil high dose in people with Healthy, run by University of Bergen at 1 site in Norway.
Trial summary
The purpose of this study is to examine whether 4 weeks daily intake of krill oil can change the omega-3 index (content of the long chained fatty acids EPA and DHA in relation to the total fatty acids) in the membrane in red blood cells. We investigate this at two different doses. Read more about this study
- Who is it for?
- Ages 18 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Krill oil low dose and Krill oil high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2014to Mar 2014
- 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 36 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young adults
Who cannot join
- Disease/illness
- Not able to swallow supplements in capsule form
- Not willing to take blood samples
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Clinical Science, University of Bergen
Bergen, Bergen, 5020
About this study
Official title: Study of the Effect of Krill Oil Supplement on Omega-3 Fatty Acid Index and Tolerance
The purpose of this study is to examine whether 4 weeks daily intake of krill oil can change the omega-3 index (content of the long chained fatty acids EPA and DHA in relation to the total fatty acids) in the membrane in red blood cells. We investigate this at two different doses. Furthermore, the purpose of the study is also to examine the effect of the krill oil intake on plasma lipids (triacylglycerol, phospholipids and cholesterol), plasma fatty acid composition, as well as product tolerance in healthy, young individuals.
- Conditions
- Healthy
- Being tested
- Krill oil low dose, Krill oil high dose
- Keywords
- krill oil, omega-3 index, plasma lipid profile, tolerance, young adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Krill oil low doseDietary supplement
Also called Rimfrost Sublime krill oil
3 capsules krill oil per day
Krill oil high doseDietary supplement
Also called Rimfrost Sublime krill oil
9 capsules krill oil per day
| Study group | Role | What they receive |
|---|---|---|
| Krill oil low dose | Experimental | 3 capsules krill oil per day, for 28 days Receives: Dietary Supplement: Krill oil low dose |
| Krill oil high dose | Experimental | 9 capsules krill oil per day, for 28 days Receives: Dietary Supplement: Krill oil high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatty acid composition in red blood cells (the membrane)
Change in fatty acid composition and omega-3 index (sum of % EPA and DHA)
Measured: Day 0 (baseline), and day 28 (end)
Secondary outcomes (4)
Fasting plasma lipid status
- Change in triacylglycerol levels.
- Change in phospholipid levels.
- Change in cholesterol levels (total, ester, free, HDL, LDL).
Measured: Day o (baseline), and day 28 (end)
Fatty acid composition in plasma.
Change in fatty acid composition and omega-3 index (sum of % EPA and DHA).
Measured: Day 0 (baseline), and day 28 (end)
Fasting glucose and glucose tolerance.
Change in fasting glucose and glucose tolerance.
Measured: Day 0 (baseline), and day 28 (end)
Tolerance of and compliance with intervention
Questionnaire-based
Measured: Day 28 (end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionMar 2014
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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Olympic Seafood AS
- Responsible party
- Principal investigator, Bodil Bjørndal, University of Bergen
- Investigators
- Per Bakke, Professor, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053415
- Sponsor's protocol ID
- Krill oil pilot-2014
- Status last verified
- Mar 2014
- First submitted
- 31 Jan 2014
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Krill Oil Supplement on Omega-3 Fatty Acid Index and Tolerance
- ClinicalTrials.gov ID
- NCT02053415
- Acronym / sponsor ID
- Krill oil pilot-2014
- Conditions
- Healthy
- Keywords
- krill oil, omega-3 index, plasma lipid profile, tolerance, young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Olympic Seafood AS
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 3 Feb 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 this study is to examine whether 4 weeks daily intake of krill oil can change the omega-3 index (content of the long chained fatty acids EPA and DHA in relation to the total fatty acids) in the membrane in red blood cells. We investigate this at two different doses. Furthermore, the purpose of the study is also to examine the effect of the krill oil intake on plasma lipids (triacylglycerol, phospholipids and cholesterol), plasma fatty acid composition, as well as product tolerance in healthy, young individuals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Krill oil low dose | Experimental | Dietary Supplement: Krill oil low dose3 capsules krill oil per day, for 28 days |
| Krill oil high dose | Experimental | Dietary Supplement: Krill oil high dose9 capsules krill oil per day, for 28 days |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy young adults
Key exclusion criteria (3 listed)
- Disease/illness
- Not able to swallow supplements in capsule form
- Not willing to take blood samples
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 oil low doseAlso: Rimfrost Sublime krill oil3 capsules krill oil per day | Dietary supplement | Krill oil low dose |
| Krill oil high doseAlso: Rimfrost Sublime krill oil9 capsules krill oil per day | Dietary supplement | Krill oil high dose |
Primary outcome
Fatty acid composition in red blood cells (the membrane)
Time frame: Day 0 (baseline), and day 28 (end)
Change in fatty acid composition and omega-3 index (sum of % EPA and DHA)
4 secondary outcomes
Fasting plasma lipid status
Time frame: Day o (baseline), and day 28 (end)
Fatty acid composition in plasma.
Time frame: Day 0 (baseline), and day 28 (end)
Fasting glucose and glucose tolerance.
Time frame: Day 0 (baseline), and day 28 (end)
Tolerance of and compliance with intervention
Time frame: Day 28 (end)
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 14 Mar 2014.
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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.
Per Bakke, Professor principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Krill oil low dose and Krill oil high dose in people with Healthy, run by University of Bergen at 1 site in Norway.
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 1 inclusion and 3 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 14 Mar 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 Norway. 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.
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?
Fatty acid composition in red blood cells (the membrane) (time frame: Day 0 (baseline), and day 28 (end)). 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 14 Mar 2014.