HealthyNCT02039128
KOmparison Study KOmparison Study
A study testing Krill oil or Fish oil in people with Healthy, run by Aker BioMarine Human Ingredients AS at 1 site in Germany.
Trial summary
In this double blind, placebo controlled, parallel group study, the relative uptake of 1g/d krill oil in comparison to 1g/d fish oil in healthy female and male adults will be assessed. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Krill oil or Fish oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Jul 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide written informed consent
- Be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator
- Be in general good health with no existing co-morbidities
- Be aged between 20 and 50 years
- Both genders allowed (at least 40% of each gender to be recruited into the study)
- Have a body mass index (BMI) between 19 and 30 kg/m² (extremes included)
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- Have a omega-3 index in erythrocytes of <6.2% at screening
- Have clinically normal findings for haematology and clinical chemistry (or clinically insignificant, if value is outside of the normal range)
- Be willing to maintain dietary habits and physical activity levels throughout the trial period (next 12 weeks)
- Have a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less (a list of fish and seafood considered to be fatty is provided to volunteers)
- Be willing to avoid all fish and seafood meals in the 3 days before each scheduled clinic visit
- Be willing to avoid alcohol in the 24 hours before each scheduled clinic visit
- Be willing to avoid sportive activity in the 24 hours before each scheduled clinic visit
- Be willing to complete questionnaires, records and diaries associated with the study
Who cannot join
- Smoking
- Diseases or disorders that include: Rheumatoid arthritis, chronic serious illness, cardiovascular problems, liver and kidney disease, diabetes, endocrine or metabolic disease, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease, neurological or psychological disease, bleeding disorders, experiences platelet abnormalities, gastrointestinal disorders that could interfere with fat absorption, acute and history of cancer, HIV, hepatitis B or C, an intention to lose weight
- Pregnant or nursing women or women of child-bearing potential whose urinary pregnancy test at screening is positive
- Postmenopausal women
- Known allergy to crustaceans (shellfish) or fish
- Known alcohol or drug abuse within the previous year of screening
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- More than 20 alcohol Units per week
- Clinically significant illness within 3 days prior to dosing (fever; inability to work etc.)
- Donation of blood or similar blood loss within the previous 30 days before screening
- Participation in a clinical trial with an investigational product within 90 days before screening
- Present or recent use (within 3 months of screening) of any medication which is a known lipid modifying agent
- Present or recent use (within 3 months of screening) of dietary supplements that affect the level of blood cholesterol and triglycerides, such as fish oil supplements, niacin, etc
- Patients with known coagulopathy or receiving anticoagulant therapy or co-morbidity that would interfere with the study results
- Frequency of fatty fish and/or seafood consumption is greater than twice per month
- Present or recent use (within 3 months of screening) of any long-chain omega-3 or omega-6 fatty acid supplement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Study to Assess Changes in the Omega-3 Index in Erythrocytes After Twelve Weeks of Daily Intake of SuperbaTM Krill Oil or Fish Oil
In this double blind, placebo controlled, parallel group study, the relative uptake of 1g/d krill oil in comparison to 1g/d fish oil in healthy female and male adults will be assessed.
Primary objective is to determine if a 12 week supplementation with krill oil increases tissue levels in erythrocytes (omega-3 index) significantly more than fish oil after dose adjustments to EPA and DHA levels.
- Conditions
- Healthy
- Being tested
- Krill oil or Fish oil, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Krill oil or Fish oilDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Krill oil | Experimental | 1 gram per day in 12 weeks Receives: Dietary Supplement: Krill oil or Fish oil |
| Fish oil | Active comparator | 1 gram per day in 12 weeks Receives: Dietary Supplement: Krill oil or Fish oil |
| Placebo | Placebo comparator | 1 gram per day in 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in relative amount of EPA and DHA in erythrocytes
Measured: Baseline to Week 12
Secondary outcomes (5)
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Baseline to Week 12
Change in relative amount of EPA and DHA in erythrocytes
Measured: Baseline to Week 6
Blood lipid status
Measured: Baseline to Week 12
Quality of Life
Measured: Baseline to week 12
Mood Scores by a Likert Scale
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionJul 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aker BioMarine Human Ingredients AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Trygve Bergeland, PhD, Study director, Aker BioMarine Human Ingredients AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039128
- Sponsor's protocol ID
- BTS743/13 // AKBM109H
- Status last verified
- Jul 2014
- First submitted
- 7 Jan 2014
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Study to Assess Changes in the Omega-3 Index in Erythrocytes After Twelve Weeks of Daily Intake of SuperbaTM Krill Oil or Fish Oil
- ClinicalTrials.gov ID
- NCT02039128
- Acronym / sponsor ID
- BTS743/13 // AKBM109H
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Aker BioMarine Human Ingredients ASIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 17 Jan 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.
In this double blind, placebo controlled, parallel group study, the relative uptake of 1g/d krill oil in comparison to 1g/d fish oil in healthy female and male adults will be assessed.
Primary objective is to determine if a 12 week supplementation with krill oil increases tissue levels in erythrocytes (omega-3 index) significantly more than fish oil after dose adjustments to EPA and DHA levels.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Krill oil | Experimental | Dietary Supplement: Krill oil or Fish oil1 gram per day in 12 weeks |
| Fish oil | Active comparator | Dietary Supplement: Krill oil or Fish oil1 gram per day in 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 gram per day in 12 weeks |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Provide written informed consent
- Be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator
- Be in general good health with no existing co-morbidities
- Be aged between 20 and 50 years
- Both genders allowed (at least 40% of each gender to be recruited into the study)
Key exclusion criteria (15 listed)
- Smoking
- Diseases or disorders that include: Rheumatoid arthritis, chronic serious illness, cardiovascular problems, liver and kidney disease, diabetes, endocrine or metabolic disease, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease, neurological or psychological disease, bleeding disorders, experiences platelet abnormalities, gastrointestinal disorders that could interfere with fat absorption, acute and history of cancer, HIV, hepatitis B or C, an intention to lose weight
- Pregnant or nursing women or women of child-bearing potential whose urinary pregnancy test at screening is positive
- Postmenopausal women
- Known allergy to crustaceans (shellfish) or fish
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 or Fish oil | Dietary supplement | Fish oil, Krill oil |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Change in relative amount of EPA and DHA in erythrocytes
Time frame: Baseline to Week 12
5 secondary outcomes
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Baseline to Week 12
Change in relative amount of EPA and DHA in erythrocytes
Time frame: Baseline to Week 6
Blood lipid status
Time frame: Baseline to Week 12
Quality of Life
Time frame: Baseline to week 12
Mood Scores by a Likert Scale
Time frame: Baseline to week 12
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 29 Jul 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.
Trygve Bergeland, PhD study director
Aker BioMarine Human Ingredients AS
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 or Fish oil in people with Healthy, run by Aker BioMarine Human Ingredients AS at 1 site in Germany.
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 14 inclusion and 15 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 29 Jul 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 Germany. 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. 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?
Change in relative amount of EPA and DHA in erythrocytes (time frame: Baseline to Week 12). 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 29 Jul 2014.