Pharmacokinetic in Normal PopulationPhase 4NCT03735836
Effect of Fish Oil Monoglycerides on the Omega-3 Index
A Phase 4 study testing MAG-EPA/MAG-DHA omega-3 oils in people with Pharmacokinetic in Normal Population, run by Samuel Fortin at 2 sites in Canada.
Trial summary
The objective of this study is to establish the pharmacokinetic curve for two different doses of MaxSimil at steady-state over a 20-week period, namely two (2) or three (3) tablets per day. MaxSimil is a concentrated fish oil monoglyceride (MAG) that facilitates absorption of the omega-3 oils by the body. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic in Normal Population
- What is being tested?
- MAG-EPA/MAG-DHA omega-3 oils
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesCanada
- Study dates
- 8 Aug 2018to 9 Aug 2019
- 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
- Participant of at least 19 years old.
- Available for the entire duration of the study and willing to participate based on the information provided in the informed consent form (ICF) duly read and signed by the latter.
- 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 coordinator of the study.
- Participant having no difficulty swallowing tablets or capsules.
Who cannot join
- Known allergy to fish or history of allergic reactions attributable to fish, or a compound similar to fish oil.
- Females who are pregnant or lactating, or has tested positive to a pregnancy test at screening.
- Participant who used omega-3 supplements within 60 days prior to Day 1 of the study.
- Participant who, in the opinion of the research coordinator, may not be able to comply with the requirements of the protocol
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Clinique Gestion Santé de la Baie
Maria, Quebec, G0C 1Y0
Clinique GSM du Littoral
Pointe-au-Père, Quebec, G0K 1P0
About this study
Official title: Effect of Fish Oil Monoglycerides on the Omega-3 Index: Pilot Study (IO3-02)
The objective of this study is to establish the pharmacokinetic curve for two different doses of MaxSimil at steady-state over a 20-week period, namely two (2) or three (3) tablets per day. MaxSimil is a concentrated fish oil monoglyceride (MAG) that facilitates absorption of the omega-3 oils by the body. Each capsule contains 300 mg of monoglyceride eicosapentaenoic acid (MAG-EPA) and 130 mg of monoglyceride docosahexaenoic acid (MAG-DHA). Thirty-two (32) subjects will be enrolled and randomly assigned to one of the two parallel treatment doses. Pharmacokinetics will be assessed by measuring the omega-3 index at eight (8) different times during the study. A first sample will be taken before the start of treatment and then every four (4) weeks during treatment. Then, two last measurements of the omega-3 index will be done at four (4) and seven (7) weeks after the end of treatment. Apart from the study treatment and collection of samples for the measurement of the omega-3 index, the only other interventions will be the measurement of body weight at screening and at the end of the study, pregnancy test for women at screening, questioning for demographic information and for the follow-up of the subject's health and concomitant medication intake.
Read the detailed description
Thirty-two (32) subjects will be enrolled and randomly assigned to one of the two parallel treatment doses. The study population will be men and women of 19 years and older, with no allergy or history of allergy to fish. Participants must not have taken omega-3 supplements in the last 60 days prior to study enrollment. Pregnant or lactating women will be excluded from the study.
The objective of this study is to establish the pharmacokinetic curve for two different doses of MaxSimil at steady-state over a 20-week period of treatment, namely two (2) or three (3) tablets per day. MaxSimil is a concentrated monoglyceride (MAG) form of omega-3 fish oil that is better absorbed by the body compared to regular fish oil. Each capsule contains 300 mg of monoglyceride eicosapentaenoic acid (MAG-EPA) and 130 mg of monoglyceride docosahexaenoic acid (MAG-DHA).
Pharmacokinetics will be assessed by measuring the omega-3 index at eight (8) different times during the study. A first blood sample will be taken before the start of treatment and then at week four (4), eight (8), twelve (12), sixteen (16) and twenty (20). Then, two last measurements of the omega-3 index will be done at four (4) and seven (7) weeks after the end of treatment. The samples will all be taken by capillary puncture during visits at the clinic. A total of nine (9) visits may be done including the recruitment/screening/enrollment visit. Visit 1 could be done immediately after enrollment for a total of eight (8) visits instead of nine.
The screening tasks include pregnancy testing for women, measurement of the omega-3 index, body weight and height, recording of the baseline health status and concomitant treatment. Then, for visits 2 to 5, study treatment will be dispensed, returned and accounted, blood sample will be collected for the measurement of the omega-3 index, and the health status will be followed for any adverse event outcome.
Visits 6 to 8 are post-treatment follow-ups where omega-3 index testing will be done as well as the follow-up of the health status and concomitant medication intake.
- Conditions
- Pharmacokinetic in Normal Population
- Being tested
- MAG-EPA/MAG-DHA omega-3 oils
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAG-EPA/MAG-DHA omega-3 oilsOther
The monoglyceride (MAG) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are chemically modified fish oils that fall into the Natural Health products category in Canada.
| Study group | Role | What they receive |
|---|---|---|
| MaxSimil 2 capsules daily | Experimental | Subjects will receive two (2) capsules per day of MAG-EPA/MAG-DHA omega-3 oils for a total of 600mg of MAG-EPA and 260mg of MAG-DHA daily during 20 consecutive weeks of treatment. Receives: Other: MAG-EPA/MAG-DHA omega-3 oils |
| MaxSimil 3 capsules daily | Experimental | Subjects will receive two (3) capsules per day of of MAG-EPA/MAG-DHA omega-3 oils for a total of 900mg of MAG-EPA and 390mg of MAG-DHA daily during 20 consecutive weeks of treatment. Receives: Other: MAG-EPA/MAG-DHA omega-3 oils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the Omega-3 index over time to establish the Pharmacokinetic curve and bioavailability at steady state.
The objective of this pilot study is to collect preliminary bioavailability data for two different daily doses of MaxSimil at steady-state, that to say 600mg/260mg and 900mg/490mg daily of EPA/DHA. Blood samples will be taken by capillary puncture at specific time points during treatment and will be analysed to establish the omega-3 index (the fraction of EPA + DHA in the total fatty acids contained in red blood cells) which serves as bioavailability marker.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start8 Aug 2018
- Primary completion9 Aug 2019
- Study completion9 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetic in Normal PopulationStudies 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
- Randomized study with two parallel treatment arms.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Fortin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Samuel Fortin, SCF Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735836
- Sponsor's protocol ID
- IO3-02
- Status last verified
- Sep 2019
- First submitted
- 2 Nov 2018
- Last updated
- 20 Sep 2019
- 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 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fish Oil Monoglycerides on the Omega-3 Index: Pilot Study (IO3-02)
- ClinicalTrials.gov ID
- NCT03735836
- Acronym / sponsor ID
- IO3-02
- Conditions
- Pharmacokinetic in Normal Population
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Samuel FortinIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 9 Aug 2019 (actual)
- First posted
- 8 Nov 2018 (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.
The objective of this study is to establish the pharmacokinetic curve for two different doses of MaxSimil at steady-state over a 20-week period, namely two (2) or three (3) tablets per day. MaxSimil is a concentrated fish oil monoglyceride (MAG) that facilitates absorption of the omega-3 oils by the body. Each capsule contains 300 mg of monoglyceride eicosapentaenoic acid (MAG-EPA) and 130 mg of monoglyceride docosahexaenoic acid (MAG-DHA). Thirty-two (32) subjects will be enrolled and randomly assigned to one of the two parallel treatment doses. Pharmacokinetics will be assessed by measuring the omega-3 index at eight (8) different times during the study. A first sample will be taken before the start of treatment and then every four (4) weeks during treatment. Then, two last measurements of the omega-3 index will be done at four (4) and seven (7) weeks after the end of treatment. Apart from the study treatment and collection of samples for the measurement of the omega-3 index, the only other interventions will be the measurement of body weight at screening and at the end of the study, pregnancy test for women at screening, questioning for demographic information and for the follow-up of the subject's health and concomitant medication intake.
Detailed description
Thirty-two (32) subjects will be enrolled and randomly assigned to one of the two parallel treatment doses. The study population will be men and women of 19 years and older, with no allergy or history of allergy to fish. Participants must not have taken omega-3 supplements in the last 60 days prior to study enrollment. Pregnant or lactating women will be excluded from the study.
The objective of this study is to establish the pharmacokinetic curve for two different doses of MaxSimil at steady-state over a 20-week period of treatment, namely two (2) or three (3) tablets per day. MaxSimil is a concentrated monoglyceride (MAG) form of omega-3 fish oil that is better absorbed by the body compared to regular fish oil. Each capsule contains 300 mg of monoglyceride eicosapentaenoic acid (MAG-EPA) and 130 mg of monoglyceride docosahexaenoic acid (MAG-DHA).
Pharmacokinetics will be assessed by measuring the omega-3 index at eight (8) different times during the study. A first blood sample will be taken before the start of treatment and then at week four (4), eight (8), twelve (12), sixteen (16) and twenty (20). Then, two last measurements of the omega-3 index will be done at four (4) and seven (7) weeks after the end of treatment. The samples will all be taken by capillary puncture during visits at the clinic. A total of nine (9) visits may be done including the recruitment/screening/enrollment visit. Visit 1 could be done immediately after enrollment for a total of eight (8) visits instead of nine.
The screening tasks include pregnancy testing for women, measurement of the omega-3 index, body weight and height, recording of the baseline health status and concomitant treatment. Then, for visits 2 to 5, study treatment will be dispensed, returned and accounted, blood sample will be collected for the measurement of the omega-3 index, and the health status will be followed for any adverse event outcome.
Visits 6 to 8 are post-treatment follow-ups where omega-3 index testing will be done as well as the follow-up of the health status and concomitant medication intake.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized study with two parallel treatment arms.
| Arm | Type | Receives |
|---|---|---|
| MaxSimil 2 capsules daily | Experimental | Other: MAG-EPA/MAG-DHA omega-3 oilsSubjects will receive two (2) capsules per day of MAG-EPA/MAG-DHA omega-3 oils for a total of 600mg of MAG-EPA and 260mg of MAG-DHA daily during 20 consecutive weeks of treatment. |
| MaxSimil 3 capsules daily | Experimental | Other: MAG-EPA/MAG-DHA omega-3 oilsSubjects will receive two (3) capsules per day of of MAG-EPA/MAG-DHA omega-3 oils for a total of 900mg of MAG-EPA and 390mg of MAG-DHA daily during 20 consecutive weeks of treatment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant of at least 19 years old.
- Available for the entire duration of the study and willing to participate based on the information provided in the informed consent form (ICF) duly read and signed by the latter.
- 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 coordinator of the study.
- Participant having no difficulty swallowing tablets or capsules.
Key exclusion criteria (4 listed)
- Known allergy to fish or history of allergic reactions attributable to fish, or a compound similar to fish oil.
- Females who are pregnant or lactating, or has tested positive to a pregnancy test at screening.
- Participant who used omega-3 supplements within 60 days prior to Day 1 of the study.
- Participant who, in the opinion of the research coordinator, may not be able to comply with the requirements of the protocol
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-DHA omega-3 oilsThe monoglyceride (MAG) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are chemically modified fish oils that fall into the Natural Health products category in Canada. | Other | MaxSimil 2 capsules daily, MaxSimil 3 capsules daily |
Primary outcome
Measurement of the Omega-3 index over time to establish the Pharmacokinetic curve and bioavailability at steady state.
Time frame: 12 months
The objective of this pilot study is to collect preliminary bioavailability data for two different daily doses of MaxSimil at steady-state, that to say 600mg/260mg and 900mg/490mg daily of EPA/DHA. Blood samples will be taken by capillary puncture at specific time points during treatment and will be analysed to establish the omega-3 index (the fraction of EPA + DHA in the total fatty acids contained in red blood cells) which serves as bioavailability marker.
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 20 Sep 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 omega-3 oils in people with Pharmacokinetic in Normal Population, run by Samuel Fortin at 2 sites 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 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Measurement of the Omega-3 index over time to establish the Pharmacokinetic curve and bioavailability at steady state. (time frame: 12 months). 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 20 Sep 2019.