Comparative BioavailabilityNCT01960660
A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products
A study testing Omega-3 Fatty Acids in people with Comparative Bioavailability, run by Nordic Pharma, USA at 1 site in Canada.
Trial summary
Supplementation with omega-3 fatty acids has been extensively researched and is known to provide healthful benefits for patients with a diversity of conditions and diseases. Not all omega-3 supplements are created equally however; some sources of omega-3 fatty acids are superior to others due to a greater… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Comparative Bioavailability
- What is being tested?
- Omega-3 Fatty Acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Jun 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is fluent in English
- Participant understands the study requirements and is willing to comply with the protocol
- Participant is willing to provide written informed consent
- Participant is 18 years of age or older
Who cannot join
- Unwilling or unable to provide written consent
- Participant has taken omega-3 supplements in the last 3 months
- Participants consumes fish on a regular basis (more than 1 serving per week)
- Females who are pregnant or breastfeeding
- Participant has an allergy to fish or seafood
- Participant has been diagnosed with any medical illness or conditions
Show all 9Show fewer
- Participant has a history of drug dependence or substance abuse (excluding nicotine)
- Participant is taking cholesterol or triglyceride lowering medications or supplements (statins, niacin, carnitine, fibrates)
- Individual has difficulty giving multiple blood samples
Trial locations and contacts
1 site in 1 country.
About this study
Supplementation with omega-3 fatty acids has been extensively researched and is known to provide healthful benefits for patients with a diversity of conditions and diseases. Not all omega-3 supplements are created equally however; some sources of omega-3 fatty acids are superior to others due to a greater bioavailability of omega-3 fatty acids than others, differences in source material, and processing techniques.
The purpose of this study is to determine which marketed omega-3 product provided the greatest effect, as measured against its' label claim and recommended dosage.
- Conditions
- Comparative Bioavailability
- Being tested
- Omega-3 Fatty Acids
- Keywords
- Fish Oil, EPA, DHA, Omega-Score, Lipemic Index, ethyl esters, triglycerides, phospholipids
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty AcidsDietary supplement
Also called EPA: Eicosapentaenoic acid (20:5(n-3)), DHA: Docosahexaenoic acid (22:6(n-3))
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product | Experimental | Omega-3 fatty acids in the form of triglycerides Receives: Dietary Supplement: Omega-3 Fatty Acids |
| Comparator Product 1 | Active comparator | Omega-3 fatty acids in the form of ethyl esters. Receives: Dietary Supplement: Omega-3 Fatty Acids |
| Comparator Product 2 | Active comparator | Omega-3 fatty acids in the form of phospholipids from krill oil. Receives: Dietary Supplement: Omega-3 Fatty Acids |
| Comparator Product 3 | Active comparator | Omega-3 fatty acids from salmon oil. Receives: Dietary Supplement: Omega-3 Fatty Acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Omega-Score
The Omega ScoreTM is a measurement of the levels of the Omega-3 Fatty Acids in a blood sample. The summed amounts of these Omega-3 Fatty Acids (EPA+DPA+DHA) as a % of the total fatty acids represents the Omega ScoreTM in whole blood.
Measured: Change from Baseline in Omega-Score at 28 days
Secondary outcomes (1)
Lipemic IndexTM
The Lipemic Index™ is the post-prandial rise in TG levels over a 5-hour period, following the consumption drink containing a measured amount of fat, carbohydrate and protein.
Measured: Change from Baseline in Lipemic Index at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startMay 2012
- Primary completionJun 2013
- Study completionJun 2013
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 Comparative BioavailabilityStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Pharma, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Maggie D Laidlaw, Ph.D, Principal investigator, Nutrasource DiagnosticsCarla Cockerline, M.Sc, Study director, Nutrasource Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960660
- Sponsor's protocol ID
- 12.0216
- Other IDs
- 12-03-001
- Status last verified
- Dec 2015
- First submitted
- 8 Oct 2013
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Laidlaw M, Cockerline CA, Rowe WJ. A randomized clinical trial to determine the efficacy of manufacturers' recommended doses of omega-3 fatty acids from different sources in facilitating cardiovascular disease risk reduction. Lipids Health Dis. 2014 Jun 21;13:99. doi: 10.1186/1476-511X-13-99.
PubMed 24952576
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products
- ClinicalTrials.gov ID
- NCT01960660
- Acronym / sponsor ID
- 12.0216
- Conditions
- Comparative Bioavailability
- Keywords
- Fish Oil, EPA, DHA, Omega-Score, Lipemic Index, ethyl esters, triglycerides, phospholipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nordic Pharma, USAIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- May 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 10 Oct 2013 (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.
Supplementation with omega-3 fatty acids has been extensively researched and is known to provide healthful benefits for patients with a diversity of conditions and diseases. Not all omega-3 supplements are created equally however; some sources of omega-3 fatty acids are superior to others due to a greater bioavailability of omega-3 fatty acids than others, differences in source material, and processing techniques.
The purpose of this study is to determine which marketed omega-3 product provided the greatest effect, as measured against its' label claim and recommended dosage.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Investigational Product | Experimental | Dietary Supplement: Omega-3 Fatty AcidsOmega-3 fatty acids in the form of triglycerides |
| Comparator Product 1 | Active comparator | Dietary Supplement: Omega-3 Fatty AcidsOmega-3 fatty acids in the form of ethyl esters. |
| Comparator Product 2 | Active comparator | Dietary Supplement: Omega-3 Fatty AcidsOmega-3 fatty acids in the form of phospholipids from krill oil. |
| Comparator Product 3 | Active comparator | Dietary Supplement: Omega-3 Fatty AcidsOmega-3 fatty acids from salmon oil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant is fluent in English
- Participant understands the study requirements and is willing to comply with the protocol
- Participant is willing to provide written informed consent
- Participant is 18 years of age or older
Key exclusion criteria (9 listed)
- Unwilling or unable to provide written consent
- Participant has taken omega-3 supplements in the last 3 months
- Participants consumes fish on a regular basis (more than 1 serving per week)
- Females who are pregnant or breastfeeding
- Participant has an allergy to fish or seafood
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 |
|---|---|---|
| Omega-3 Fatty AcidsAlso: EPA: Eicosapentaenoic acid (20:5(n-3)), DHA: Docosahexaenoic acid (22:6(n-3)) | Dietary supplement | Comparator Product 1, Comparator Product 2, Comparator Product 3, Investigational Product |
Primary outcome
Omega-Score
Time frame: Change from Baseline in Omega-Score at 28 days
The Omega ScoreTM is a measurement of the levels of the Omega-3 Fatty Acids in a blood sample. The summed amounts of these Omega-3 Fatty Acids (EPA+DPA+DHA) as a % of the total fatty acids represents the Omega ScoreTM in whole blood.
1 secondary outcome
Lipemic IndexTM
Time frame: Change from Baseline in Lipemic Index at 28 days
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 Dec 2015.
- Derived from this study: PubMed 24952576Laidlaw M, Cockerline CA, Rowe WJ. A randomized clinical trial to determine the efficacy of manufacturers' recommended doses of omega-3 fatty acids from different sources in facilitating cardiovascular disease risk reduction. Lipids Health Dis. 2014 Jun 21;13:99. doi: 10.1186/1476-511X-13-99.
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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.
Maggie D Laidlaw, Ph.D principal investigator
Nutrasource Diagnostics
Carla Cockerline, M.Sc study director
Nutrasource Diagnostics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Fatty Acids in people with Comparative Bioavailability, run by Nordic Pharma, USA at 1 site in Canada.
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 9 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 Dec 2015. 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 Canada. 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?
Omega-Score (time frame: Change from Baseline in Omega-Score at 28 days). 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 NCT01960660, 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 14 Dec 2015.