Healthy AdultsPhase 4NCT04159532
Comparative Study of Three Different Formulations of Omega-3 (EPA+DHA)
A Phase 4 study testing MAG-EPA/MAG-DHA, TG-EPA/TG-DHA and EE-EPA/EE-DHA in people with Healthy Adults, run by SCF Pharma at 1 site in Canada.
Trial summary
This pilot study aims at comparing the bioavailability of three different formulations of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). The three formulations are ethyl ester (EE), triglyceride (TG) and monoglyceride (MAG). Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- MAG-EPA/MAG-DHA, TG-EPA/TG-DHA and EE-EPA/EE-DHA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 18 Dec 2019to 25 Feb 2021
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants of at least 19 years of age.
- Availability for the entire duration of the study, willingness to participate as evidenced by the informed consent form duly read and signed by the participant.
- Absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements, ability to cooperate adequately, to understand and observe the instructions of the physician or delegates.
- Participant having no difficulty swallowing tablets or capsules.
Who cannot join
- Known allergy or intolerance to fish or history of allergic reaction attributable to fish or to a compound similar to fish oil.
- Females who are pregnant according to the qualitative pregnancy test or who are lactating.
- Participants who took omega-3 supplements in the previous 60 days before day 1 of the study.
- Difficulty to draw blood by capillary puncture at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Bioavailability Study of Monoglyceride (MAG) Versus Triglyceride (TG) Versus Ethyl Ester (EE) Formulations of Eicosapentaenoic (EPA) and Docosahexaenoic (DHA) Acids. Pilot Study (IO3-03)
This pilot study aims at comparing the bioavailability of three different formulations of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). The three formulations are ethyl ester (EE), triglyceride (TG) and monoglyceride (MAG). Thirty six (36) subjects will be divided in three groups of twelve subjects each equally divided in two study sites. Each group will be taking one of the three different formulations of EPA+DHA at a daily dose of 1.5g for a period of 12 weeks. Bioavailability will be measured through omega-3 index (total content of EPA + DHA in red blood cell membranes) at baseline and every four weeks during treatment.
Read the detailed description
This pilot study aims at comparing the bioavailability of three different formulations of a combination of omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a standardized proportion of 460:200. The three formulations are ethyl ester (EE), triglyceride (TG) and monoglyceride (MAG) versions of these fatty acids. The formulations are prepared in a way to be similar in proportion of EPA/DHA, in dose and in appearance. Thirty six (36) subjects will be divided in three groups of twelve subjects each, equally divided in two study sites. The study will be randomized and double blinded. Each group will be taking one of the three different formulations of EPA+DHA at a daily dose of 1.5g for a period of 12 weeks. Bioavailability will be measured through omega-3 index (total content of EPA + DHA in red blood cell membranes) at baseline and every four weeks during treatment. After recruitment, subjects will be seen in clinic every four weeks for a total of four (4) study visits during which a blood sample will be taken for analysis of the omega-3 index, the investigational product will be returned and dispensed and finally, adverse events will be noted and followed. Treatment will be self-administered by subjects at home. They will be asked to keep a journal of adverse events, concomitant medication and to note every missed dose as well as significant changes in life habits (smoking, alcohol, sports, food diet and natural health products intake).
- Conditions
- Healthy Adults
- Being tested
- MAG-EPA/MAG-DHA, TG-EPA/TG-DHA, EE-EPA/EE-DHA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAG-EPA/MAG-DHADietary supplement
monoglyceride of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200
TG-EPA/TG-DHADietary supplement
Triglyceride of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200
EE-EPA/EE-DHADietary supplement
Ethyl ester of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200
| Study group | Role | What they receive |
|---|---|---|
| Monoglyceride (MAG) | Experimental | Group A will receive the omega-3 fatty acids in monoglyceride formulation (MAG). Subjects will receive 1.5g per day of MAG-EPA/MAG-DHA in a proportion of 460:200 for 12 consecutive weeks. Receives: Dietary Supplement: MAG-EPA/MAG-DHA |
| Triglyceride (TG) | Active comparator | Group B will receive the omega-3 fatty acids in triglyceride formulation (TG). Subjects will receive 1.5g per day of TG-EPA/TG-DHA in a proportion of 460:200 for 12 consecutive weeks. Receives: Dietary Supplement: TG-EPA/TG-DHA |
| Ethyl Ester(EE) | Active comparator | Group C will receive the omega-3 fatty acids in Ethyl ester formulation (EE). Subjects will receive 1.5g per day of EE-EPA/EE-DHA in a proportion of 460:200 for 12 consecutive weeks. Receives: Dietary Supplement: EE-EPA/EE-DHA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the bioavailability of the three different formulations of omega-3 fatty acids at study.
The Omega-3 index (ratio of EPA + DHA content on total fatty acids in red blood cells) will be measured throughout the study (at baseline and every four weeks afterwards) for each subjects. The average value in canadian population is 4.5%, however, for an optimized health, the desired index should be between 8 and 12% of omega-3 in cell membranes. The average omega-3 index curves obtained for each group will be compared to determine which formulation offers the best absorption of omega-3 in the organism.
Measured: 12 weeks per subject
Secondary outcomes (2)
Incidence of adverse events in subjects treated with EPA +DHA
Subjects will be questioned about any changes in their health status throughout the study, and for the 30 days following the end of treatment. All adverse events will recorded and evaluated for severity, causality and expectedness. All serious adverse events will be reported as required.
Measured: 16 weeks per subject
Compilation of life habits & demographic information
Demographic information and life habits will be recorded at screening as to draw a portrait of the subjects baseline status. A follow-up of life habits at every visit will be done afterwards as a way to control any possible bias in outcomes.
Measured: 12 weeks per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start18 Dec 2019
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, 3-arms parallel randomized study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCF Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Fortin, PhD, Principal investigator, SCF Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159532
- Sponsor's protocol ID
- IO3-03
- Status last verified
- Apr 2021
- First submitted
- 6 Nov 2019
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Bioavailability Study of Monoglyceride (MAG) Versus Triglyceride (TG) Versus Ethyl Ester (EE) Formulations of Eicosapentaenoic (EPA) and Docosahexaenoic (DHA) Acids. Pilot Study (IO3-03)
- ClinicalTrials.gov ID
- NCT04159532
- Acronym / sponsor ID
- IO3-03
- Conditions
- Healthy Adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SCF PharmaIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 12 Nov 2019 (actual)
- 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.
This pilot study aims at comparing the bioavailability of three different formulations of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). The three formulations are ethyl ester (EE), triglyceride (TG) and monoglyceride (MAG). Thirty six (36) subjects will be divided in three groups of twelve subjects each equally divided in two study sites. Each group will be taking one of the three different formulations of EPA+DHA at a daily dose of 1.5g for a period of 12 weeks. Bioavailability will be measured through omega-3 index (total content of EPA + DHA in red blood cell membranes) at baseline and every four weeks during treatment.
Detailed description
This pilot study aims at comparing the bioavailability of three different formulations of a combination of omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a standardized proportion of 460:200. The three formulations are ethyl ester (EE), triglyceride (TG) and monoglyceride (MAG) versions of these fatty acids. The formulations are prepared in a way to be similar in proportion of EPA/DHA, in dose and in appearance. Thirty six (36) subjects will be divided in three groups of twelve subjects each, equally divided in two study sites. The study will be randomized and double blinded. Each group will be taking one of the three different formulations of EPA+DHA at a daily dose of 1.5g for a period of 12 weeks. Bioavailability will be measured through omega-3 index (total content of EPA + DHA in red blood cell membranes) at baseline and every four weeks during treatment. After recruitment, subjects will be seen in clinic every four weeks for a total of four (4) study visits during which a blood sample will be taken for analysis of the omega-3 index, the investigational product will be returned and dispensed and finally, adverse events will be noted and followed. Treatment will be self-administered by subjects at home. They will be asked to keep a journal of adverse events, concomitant medication and to note every missed dose as well as significant changes in life habits (smoking, alcohol, sports, food diet and natural health products intake).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind, 3-arms parallel randomized study.
| Arm | Type | Receives |
|---|---|---|
| Monoglyceride (MAG) | Experimental | Dietary Supplement: MAG-EPA/MAG-DHAGroup A will receive the omega-3 fatty acids in monoglyceride formulation (MAG). Subjects will receive 1.5g per day of MAG-EPA/MAG-DHA in a proportion of 460:200 for 12 consecutive weeks. |
| Triglyceride (TG) | Active comparator | Dietary Supplement: TG-EPA/TG-DHAGroup B will receive the omega-3 fatty acids in triglyceride formulation (TG). Subjects will receive 1.5g per day of TG-EPA/TG-DHA in a proportion of 460:200 for 12 consecutive weeks. |
| Ethyl Ester(EE) | Active comparator | Dietary Supplement: EE-EPA/EE-DHAGroup C will receive the omega-3 fatty acids in Ethyl ester formulation (EE). Subjects will receive 1.5g per day of EE-EPA/EE-DHA in a proportion of 460:200 for 12 consecutive weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants of at least 19 years of age.
- Availability for the entire duration of the study, willingness to participate as evidenced by the informed consent form duly read and signed by the participant.
- Absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements, ability to cooperate adequately, to understand and observe the instructions of the physician or delegates.
- Participant having no difficulty swallowing tablets or capsules.
Key exclusion criteria (4 listed)
- Known allergy or intolerance to fish or history of allergic reaction attributable to fish or to a compound similar to fish oil.
- Females who are pregnant according to the qualitative pregnancy test or who are lactating.
- Participants who took omega-3 supplements in the previous 60 days before day 1 of the study.
- Difficulty to draw blood by capillary puncture at screening.
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 |
|---|---|---|
| MAG-EPA/MAG-DHAmonoglyceride of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200 | Dietary supplement | Monoglyceride (MAG) |
| TG-EPA/TG-DHATriglyceride of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200 | Dietary supplement | Triglyceride (TG) |
| EE-EPA/EE-DHAEthyl ester of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200 | Dietary supplement | Ethyl Ester(EE) |
Primary outcome
Comparing the bioavailability of the three different formulations of omega-3 fatty acids at study.
Time frame: 12 weeks per subject
The Omega-3 index (ratio of EPA + DHA content on total fatty acids in red blood cells) will be measured throughout the study (at baseline and every four weeks afterwards) for each subjects. The average value in canadian population is 4.5%, however, for an optimized health, the desired index should be between 8 and 12% of omega-3 in cell membranes. The average omega-3 index curves obtained for each group will be compared to determine which formulation offers the best absorption of omega-3 in the organism.
2 secondary outcomes
Incidence of adverse events in subjects treated with EPA +DHA
Time frame: 16 weeks per subject
Compilation of life habits & demographic information
Time frame: 12 weeks per subject
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 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Samuel Fortin, PhD principal investigator
SCF Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MAG-EPA/MAG-DHA, TG-EPA/TG-DHA and EE-EPA/EE-DHA in people with Healthy Adults, run by SCF Pharma 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 4 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 Apr 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Comparing the bioavailability of the three different formulations of omega-3 fatty acids at study. (time frame: 12 weeks per subject). 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 Apr 2021.