Healthy AdultsKOMPARENCT02427373
A Parallel Bioavailability Study of Fish Oil-Ethyl Ester Versus Fish Oil-Triglyceride Versus Krill Oil
A study testing fish oil ethyl ester, fish oil triglyceride and krill oil in people with Healthy Adults, run by dsm-firmenich Switzerland AG.
Trial summary
A multiple-dose, double-blind, randomized, four-week, three-treatment, parallel study in which 66 healthy adult subjects will receive 6 capsules/d, administered as a dose of 1.3 g/d eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) in fish oil ethyl ester (EE), or fish oil triglyceride (TG) or krill oil for a… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- fish oil ethyl ester, fish oil triglyceride and krill oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Dec 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy,
- adult female who is neither pregnant nor breastfeeding, or
- a healthy, adult male
- with a body mass index (BMI) between 18 and 30 kg/m2 (inclusive), and
- with a minimum weight of 50 kg (110 lbs).
Who cannot join
- history or presence of diabetes, high triglycerides (≥240 mg/dL), or high cholesterol (≥240 mg/dL);
- clinically significant abnormal finding on the physical exam, medical history, vital signs, or clinical laboratory results at screening;
- history or presence of allergic response to omega-3-fatty acids or sensitivity or allergy to fish or shellfish;
- history of coagulation disorder or current anticoagulation therapy;
- has used any nutritional supplements, omega-3 supplements, fish oil, chia, krill oil, flaxseed or foods supplemented with omega-3s within 3 months prior to the first dose of study medication;
- has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.
About this study
A multiple-dose, double-blind, randomized, four-week, three-treatment, parallel study in which 66 healthy adult subjects will receive 6 capsules/d, administered as a dose of 1.3 g/d eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) in fish oil ethyl ester (EE), or fish oil triglyceride (TG) or krill oil for a total of 4 weeks. The objective of the study is to compare the oral bioavailability of EPA+DHA in total plasma across the three formulations at the end of the 4 week study.
- Conditions
- Healthy Adults
- Being tested
- fish oil ethyl ester, fish oil triglyceride, krill oil
- Keywords
- bioavailability, fish oil, krill oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fish oil ethyl esterDietary supplement
fish oil triglycerideDietary supplement
krill oilDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| fish oil ethyl ester | Active comparator | 1.3g/d dose of DHA+EPA in fish oil EE (6 capsules) administered for 4 weeks Receives: Dietary Supplement: fish oil ethyl ester |
| fish oil triglyceride | Active comparator | 1.3g/d dose of DHA+EPA in fish oil TG (6 capsules) administered for 4 weeks Receives: Dietary Supplement: fish oil triglyceride |
| krill oil | Active comparator | 1.3g/d dose of DHA+EPA in krill oil (6 capsules) administered for 4 weeks Receives: Dietary Supplement: krill oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of total plasma DHA+EPA levels across 3 treatment groups
Measured: 4 weeks
Secondary outcomes (5)
Comparison of RBC DHA+EPA levels across 3 treatment groups
Measured: 4 weeks
pharmacokinetic parameter: AUC to 672hr
Measured: 4 weeks
pharmacokinetic parameter: AUC to 336hr
Measured: 2 weeks
pharmacokinetic parameter: Cmax
Measured: 4 weeks
pharmacokinetic parameter: Tmax
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startJun 2014
- Primary completionAug 2014
- Study completionDec 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 Healthy AdultsStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vanessa Smeberg, MD, Principal investigator, Worldwide Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427373
- Sponsor's protocol ID
- 2013-10701
- Acronym
- KOMPARE
- Status last verified
- Apr 2015
- First submitted
- 20 Apr 2015
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Yurko-Mauro K, Kralovec J, Bailey-Hall E, Smeberg V, Stark JG, Salem N Jr. Similar eicosapentaenoic acid and docosahexaenoic acid plasma levels achieved with fish oil or krill oil in a randomized double-blind four-week bioavailability study. Lipids Health Dis. 2015 Sep 2;14:99. doi: 10.1186/s12944-015-0109-z.
PubMed 26328782
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Bioavailability Study of Fish Oil-Ethyl Ester Versus Fish Oil-Triglyceride Versus Krill Oil
- ClinicalTrials.gov ID
- NCT02427373
- Acronym / sponsor ID
- KOMPARE / 2013-10701
- Conditions
- Healthy Adults
- Keywords
- bioavailability, fish oil, krill oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Apr 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.
A multiple-dose, double-blind, randomized, four-week, three-treatment, parallel study in which 66 healthy adult subjects will receive 6 capsules/d, administered as a dose of 1.3 g/d eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) in fish oil ethyl ester (EE), or fish oil triglyceride (TG) or krill oil for a total of 4 weeks. The objective of the study is to compare the oral bioavailability of EPA+DHA in total plasma across the three formulations at the end of the 4 week study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fish oil ethyl ester | Active comparator | Dietary Supplement: fish oil ethyl ester1.3g/d dose of DHA+EPA in fish oil EE (6 capsules) administered for 4 weeks |
| fish oil triglyceride | Active comparator | Dietary Supplement: fish oil triglyceride1.3g/d dose of DHA+EPA in fish oil TG (6 capsules) administered for 4 weeks |
| krill oil | Active comparator | Dietary Supplement: krill oil1.3g/d dose of DHA+EPA in krill oil (6 capsules) administered for 4 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy,
- adult female who is neither pregnant nor breastfeeding, or
- a healthy, adult male
- with a body mass index (BMI) between 18 and 30 kg/m2 (inclusive), and
- with a minimum weight of 50 kg (110 lbs).
Key exclusion criteria (6 listed)
- history or presence of diabetes, high triglycerides (≥240 mg/dL), or high cholesterol (≥240 mg/dL);
- clinically significant abnormal finding on the physical exam, medical history, vital signs, or clinical laboratory results at screening;
- history or presence of allergic response to omega-3-fatty acids or sensitivity or allergy to fish or shellfish;
- history of coagulation disorder or current anticoagulation therapy;
- has used any nutritional supplements, omega-3 supplements, fish oil, chia, krill oil, flaxseed or foods supplemented with omega-3s within 3 months prior to the first dose of study medication;
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 |
|---|---|---|
| fish oil ethyl ester | Dietary supplement | fish oil ethyl ester |
| fish oil triglyceride | Dietary supplement | fish oil triglyceride |
| krill oil | Dietary supplement | krill oil |
Primary outcome
Comparison of total plasma DHA+EPA levels across 3 treatment groups
Time frame: 4 weeks
5 secondary outcomes
Comparison of RBC DHA+EPA levels across 3 treatment groups
Time frame: 4 weeks
pharmacokinetic parameter: AUC to 672hr
Time frame: 4 weeks
pharmacokinetic parameter: AUC to 336hr
Time frame: 2 weeks
pharmacokinetic parameter: Cmax
Time frame: 4 weeks
pharmacokinetic parameter: Tmax
Time frame: 4 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 28 Apr 2015.
- Derived from this study: PubMed 26328782Yurko-Mauro K, Kralovec J, Bailey-Hall E, Smeberg V, Stark JG, Salem N Jr. Similar eicosapentaenoic acid and docosahexaenoic acid plasma levels achieved with fish oil or krill oil in a randomized double-blind four-week bioavailability study. Lipids Health Dis. 2015 Sep 2;14:99. doi: 10.1186/s12944-015-0109-z.
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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.
Vanessa Smeberg, MD principal investigator
Worldwide Clinical Trials
Questions about this trial
What is this clinical trial studying?
A study testing fish oil ethyl ester, fish oil triglyceride and krill oil in people with Healthy Adults, run by dsm-firmenich Switzerland AG.
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 5 inclusion and 6 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 28 Apr 2015. 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. 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?
Comparison of total plasma DHA+EPA levels across 3 treatment groups (time frame: 4 weeks). 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 NCT02427373, 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 28 Apr 2015.