A Phase 4 interventional study of Eicosapentaenoic acid monoglycerid (MAG-EPA) in Inflammation, sponsored by SCF Pharma. Completed at 2 sites in Canada. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-27.
Sponsored by SCF Pharma · Phase 4, Interventional, and Supportive care
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.
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
1.2 Secondary objectives
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 2,577 interventional studies indexed under Inflammation.
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Exclusion Criteria:
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.
Other: 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).
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).
Time frame: 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 16 weeks
Ran from Apr 2021 to primary completion in Apr 2023, 23 months.
Of 86 phase 4 interventional studies under Inflammation, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's 23 months is close to that.
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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