InflammationPhase 4IO3-04NCT04897893

Impact of 2.0g Daily of MAG-EPA on the AA/EPA Ratio and Inflammation Biomarkers in a Healthy Population Aged of 50+.

A Phase 4 study testing Eicosapentaenoic acid monoglycerid (MAG-EPA) in people with Inflammation, run by SCF Pharma at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Inflammation
What is being tested?: Eicosapentaenoic acid monoglycerid (MAG-EPA)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 2 sitesCanada
Study dates: 21 Apr 2021to 14 Sep 2023
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 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participant aged 50 or over.
Available for the entire duration of the study and willing to participate based on the information provided in the ICF duly read and signed by the latter.
Participant not presenting any intellectual problems likely to limit the validity of the consent to participate in the study and the respect of protocol requirements, having the capacity to cooperate adequately, to understand and to follow the instructions of the doctor or his delegates.
Participant who has no difficulty swallowing tablets or capsules.

Who cannot join

Known allergy or intolerance to fish or history of allergic reactions attributable to fish, or to a compound similar to fish oil.
Pregnant or breastfeeding woman.
Participant who used omega-3 supplements within 60 days of study day 1.
Difficulty obtaining blood samples by capillary or venous puncture at the time of selection.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

SCF Pharma
Maria, Quebec, G0C 1Y0
SCF Pharma
Rimouski, Quebec, G0K 1P0

Other trials in Canada

About this study

Official title: Impact of a Daily Supplementation With 2.0g of Eicosapentaenoic Acid Monoglycerids (MAG-EPA) on the Arachidonic and Eicosapentaenoic Acids Ratio (AA/EPA) and on Blood Inflammation Markers in a Healthy Population Aged of 50 and Older.

According to scientific literature, oils containing omega-3 fatty acids may decrease certain risk factors for cardiovascular disease such as blood pressure, blood level of triglycerides (TGs) and cholesterol. The omega-3 index (amount of EPA + DHA in the blood) is a recognized biomarker for assessing risk factors for cardiovascular disease. Its optimal value is 8% compared to the Canadian population average of only 4.5%. The scientific literature contains several good studies on omega-3 fatty acids, however, it is difficult to compare dose-response relationships between studies since formulations are not similar and markers of exposure to treatment are not standardized. The AA/EPA ratio, combined with the omega-3 index, is a good way to monitor the increase in omega-3 levels in the blood, but especially to determine the inflammatory status of a patient. Indeed, eicosapentaenoic acid (EPA) is a fatty acid with inflammation-resolving properties, while arachidonic acid (AA) is a pro-inflammatory agent. A high AA/EPA ratio therefore indicates a high inflammatory status while a low ratio indicates a better balance between active inflammation and its resolution. Moreover, it was published in 2018 that a AA/EPA ratio of around 3 was directly associated with a 25% reduction in the relative risk of cardiovascular disease. Therefore, the investigator wants to determine the minimum MAG-EPA dose needed to achieve an AA/EPA ratio equivalent to 4g of EPA in the form of ethyl ester (EE-EPA). It is reasonable to estimate that 2g of MAG-EPA should be sufficient to produce an average AA/EPA ratio around 3.1.

Read the detailed description

This pilot study aims to determine the average value of the ratio of arachidonic to eicosapentaenoic acids (AA/EPA) in a population aged 50 and over without any particular medical condition when supplemented with 2g per day of MAG-EPA for 12 weeks.

1.1 Main objectives

To recruit a population of 30 subjects aged 50 and over without any particular medical condition in order to administer 2.0g of MAG-EPA per day for 12 weeks.
By measuring the omega-3 index level of all subjects before starting the study and thereafter every 6 weeks over a total period of 12 weeks, the investigator will analyse the individual levels of arachidonic acids and eicosapentaenoic acids to establish the AA/EPA ratio at each visit.
The initial AA/EPA ratio will be compared to that obtained after 12 weeks of MAG-EPA supplementation. The results of the present study will be compared to those obtained by daily supplementation with 4.0g of EE-EPA over a similar period of time (taken from the scientific literature) to determine whether MAG-EPA meets the statistical criteria for non- inferiority in terms of response to the AA/EPA ratio.

1.2 Secondary objectives

Analyze markers of inflammation such as CRP and PSA (in men only) as well as COX-2 activity before starting the study and thereafter every 6 weeks for a total period of 12 weeks in order to identify the best clinical markers of response to MAG-EPA in the context of the treatment of inflammation.
Analyze the lipid profile, before starting the study and thereafter every 6 weeks over a total period of 12 weeks in order to better characterize the effects of MAG-EPA supplementation on this clinical parameter.
Determine the proportion of participants who achieve an omega-3 index of at least 8%.
Characterize the effects of MAG-EPA supplementation on the proportion of senescent white blood cells, on the omega-6/omega-3 ratio as well as on the subject's blood trans fat content.

Conditions: Inflammation
Being tested: Eicosapentaenoic acid monoglycerid (MAG-EPA)
Keywords: COX-2, Inflammation, MAG-EPA
Medical subject headings: Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Eicosapentaenoic acid monoglycerid (MAG-EPA)Other
MAG-EPA is an omega-3 fatty acid classified in canada as a Natural Health Product (NHP). The NHP is approuved under the Natural Health Product number (NPN # 80050187).

Study groups in NCT04897893
Study group	Role	What they receive
Experimental Treatment	Experimental	All subjects enrolled in the study will receive an identical dose of 2g/day (4 capsules of MAG-EPA) which will be taken by the subject at home. The duration of treatment should not be prolonged in the event of missed doses, that is, treatment should end on the 84th day as planned. A deviation of ± 3 days is acceptable, which means that treatment can be stopped from day 81 to day 87 of subject's participation. Receives: Other: Eicosapentaenoic acid monoglycerid (MAG-EPA)

What is being measured

The primary outcome is the main question the study is designed to answer.

Fatty acids profile analysis
The individual content of all fatty acids present in humans will be analysed for each subject on red blood cells obtained by blood sampling after 6 and 12 weeks of supplementation with eicosapentaenoic acid monoglycerides (MAG-EPA). With the individual fatty acid contents obtained for each timepoint, it will be possible to calculate an omega-3 index (% of omega-3, EPA + DHA, on total fatty acids), the total omega-6/omega-3 ratio and finally, the ratio of arachidonic acids to eicosapentaenoic acids (AA/EPA).
Measured: 12 weeks

Secondary outcomes (5)

Research of clinical biomarkers for inflammation.
For each timepoint (0, 6 and 12 weeks), PSA (for men only) and CRP will be analysed through the health services laboratories. The activity of the COX-2 protein will also be analysed in Dr Fortin's research laboratory. The results at 6 and 12 weeks will be compared to the baseline analysis to evaluate the potential in resolution of inflammation when subjects are supplemented with 2.0g daily of MAG-EPA.
Measured: 12 weeks
Proportion of subjects with a 8% or higher omega-3 index after 12 weeks of supplementation
The omega-3 index will be analysed for all subjects included in the study after 6 and 12 weeks of supplementation with 2.0g of MAG-EPA. The proportion of subjects with an omega-3 index equal or higher to 8% will be calculated at this dose for the 12 weeks timepoint.
Measured: 12 weeks
Impact of supplementation on proportion of senescent white blood cells.
At each study visit (week 0, 6 and 12), a whole blood sample will be sent to the laboratory of Dr Fortin for a flow cytometry analysis. The proportion of senescent white blood cells at last visit will be compared to the proportion obtained at baseline.
Measured: 12 weeks
Comparison of pre and post-dose Lipid profile.
At each study visit (week 0, 6 and 12), a whole blood sample will be sent to the health services laboratory for a lipid profile analysis. The results at last visit will be compared to those obtained at baseline and week 6 to detect any change caused by supplementation.
Measured: 12 weeks
Obsevation and research of any adverse events
Subjects will be questionned about any changes in their health status at each study visit (week 0, week 6 and week 12). A telephone follow-up will be done halfway between visits (week 3 and week 9).They will also be instructed to note and report any change in their health status between follow-ups. For each adverse event, the following will be noted: start date, time and severity; end date, time, maximal severity and outcome; seriousness, causal relationship to study drug and expectedness.
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Apr 202114 Sep 2023

First posted24 May 2021
Study start21 Apr 2021
Primary completion5 Apr 2023
Study completion14 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InflammationStudies 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: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: A prospective, single-arm, phase IV pilot study where all participants receive the same treatment for a similar duration. Their pre-treatment baseline condition will serve as a comparator for the effects observed following MAG-EPA treatment. There is no control group in this study.
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04897893
Sponsor's protocol ID: IO3-04
Acronym: IO3-04
Status last verified: Nov 2023
First submitted: 18 May 2021
Last updated: 27 Nov 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis

All Inflammation trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of a Daily Supplementation With 2.0g of Eicosapentaenoic Acid Monoglycerids (MAG-EPA) on the Arachidonic and Eicosapentaenoic Acids Ratio (AA/EPA) and on Blood Inflammation Markers in a Healthy Population Aged of 50 and Older.
ClinicalTrials.gov ID: NCT04897893
Acronym / sponsor ID: IO3-04 / IO3-04
Conditions: Inflammation
Keywords: COX-2, Inflammation, MAG-EPA
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: SCF PharmaIndustry (pharma, biotech, devices)
Collaborators: Integrated Health and Social Services Centres (CISSS) de la Gaspésie, Integrated Health and Social Services Centres (CISSS) du Bas-St-Laurent
Study start: 21 Apr 2021 (actual)
Primary completion: 5 Apr 2023 (actual)
Study completion: 14 Sep 2023 (actual)
First posted: 24 May 2021 (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.

Detailed description

1.1 Main objectives

To recruit a population of 30 subjects aged 50 and over without any particular medical condition in order to administer 2.0g of MAG-EPA per day for 12 weeks.
By measuring the omega-3 index level of all subjects before starting the study and thereafter every 6 weeks over a total period of 12 weeks, the investigator will analyse the individual levels of arachidonic acids and eicosapentaenoic acids to establish the AA/EPA ratio at each visit.
The initial AA/EPA ratio will be compared to that obtained after 12 weeks of MAG-EPA supplementation. The results of the present study will be compared to those obtained by daily supplementation with 4.0g of EE-EPA over a similar period of time (taken from the scientific literature) to determine whether MAG-EPA meets the statistical criteria for non- inferiority in terms of response to the AA/EPA ratio.

1.2 Secondary objectives

Analyze markers of inflammation such as CRP and PSA (in men only) as well as COX-2 activity before starting the study and thereafter every 6 weeks for a total period of 12 weeks in order to identify the best clinical markers of response to MAG-EPA in the context of the treatment of inflammation.
Analyze the lipid profile, before starting the study and thereafter every 6 weeks over a total period of 12 weeks in order to better characterize the effects of MAG-EPA supplementation on this clinical parameter.
Determine the proportion of participants who achieve an omega-3 index of at least 8%.
Characterize the effects of MAG-EPA supplementation on the proportion of senescent white blood cells, on the omega-6/omega-3 ratio as well as on the subject's blood trans fat content.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A prospective, single-arm, phase IV pilot study where all participants receive the same treatment for a similar duration. Their pre-treatment baseline condition will serve as a comparator for the effects observed following MAG-EPA treatment. There is no control group in this study.

Arm	Type	Receives
Experimental Treatment	Experimental	Other: Eicosapentaenoic acid monoglycerid (MAG-EPA)All subjects enrolled in the study will receive an identical dose of 2g/day (4 capsules of MAG-EPA) which will be taken by the subject at home. The duration of treatment should not be prolonged in the event of missed doses, that is, treatment should end on the 84th day as planned. A deviation of ± 3 days is acceptable, which means that treatment can be stopped from day 81 to day 87 of subject's participation.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Participant aged 50 or over.
Available for the entire duration of the study and willing to participate based on the information provided in the ICF duly read and signed by the latter.
Participant not presenting any intellectual problems likely to limit the validity of the consent to participate in the study and the respect of protocol requirements, having the capacity to cooperate adequately, to understand and to follow the instructions of the doctor or his delegates.
Participant who has no difficulty swallowing tablets or capsules.

Key exclusion criteria (4 listed)

Known allergy or intolerance to fish or history of allergic reactions attributable to fish, or to a compound similar to fish oil.
Pregnant or breastfeeding woman.
Participant who used omega-3 supplements within 60 days of study day 1.
Difficulty obtaining blood samples by capillary or venous puncture at the time of selection.

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
Eicosapentaenoic acid monoglycerid (MAG-EPA)MAG-EPA is an omega-3 fatty acid classified in canada as a Natural Health Product (NHP). The NHP is approuved under the Natural Health Product number (NPN # 80050187).	Other	Experimental Treatment

Primary outcome

Fatty acids profile analysis
Time frame: 12 weeks
The individual content of all fatty acids present in humans will be analysed for each subject on red blood cells obtained by blood sampling after 6 and 12 weeks of supplementation with eicosapentaenoic acid monoglycerides (MAG-EPA). With the individual fatty acid contents obtained for each timepoint, it will be possible to calculate an omega-3 index (% of omega-3, EPA + DHA, on total fatty acids), the total omega-6/omega-3 ratio and finally, the ratio of arachidonic acids to eicosapentaenoic acids (AA/EPA).

5 secondary outcomes

Research of clinical biomarkers for inflammation.
Time frame: 12 weeks
Proportion of subjects with a 8% or higher omega-3 index after 12 weeks of supplementation
Time frame: 12 weeks
Impact of supplementation on proportion of senescent white blood cells.
Time frame: 12 weeks
Comparison of pre and post-dose Lipid profile.
Time frame: 12 weeks
Obsevation and research of any adverse events
Time frame: 16 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 27 Nov 2023.

Related trials for Inflammation

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis

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 C Fortin, PhD principal investigator

SCF Pharma

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 Eicosapentaenoic acid monoglycerid (MAG-EPA) in people with Inflammation, run by SCF Pharma 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 27 Nov 2023. 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?

Fatty acids profile analysis (time frame: 12 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 NCT04897893.

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 27 Nov 2023.