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

NCT04897893 | Completed Phase 4

• 1 other identifier: IO3-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Inflammation

Keywords

COX-2, Inflammation, MAG-EPA

Outcome Measures

Primary Outcomes (1)

• 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).

  12 weeks

Secondary Outcomes (5)

• Research of clinical biomarkers for inflammation.

  12 weeks

• Proportion of subjects with a 8% or higher omega-3 index after 12 weeks of supplementation

  12 weeks

• Impact of supplementation on proportion of senescent white blood cells.

  12 weeks

• Comparison of pre and post-dose Lipid profile.

  12 weeks

• Obsevation and research of any adverse events

  16 weeks

Study Arms (1)

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.

Other: Eicosapentaenoic acid monoglycerid (MAG-EPA)

Interventions

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).

Experimental Treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SCF Pharma: lead
• Integrated Health and Social Services Centres (CISSS) de la Gaspésie: collaborator
• Integrated Health and Social Services Centres (CISSS) du Bas-St-Laurent: collaborator

Study Sites (2)

SCF Pharma

Maria, Quebec, G0C 1Y0, Canada

Location

SCF Pharma

Rimouski, Quebec, G0K 1P0, Canada

Location

MeSH Terms

Conditions

Inflammation

Interventions

1-eicosapentaenoylglycerol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel C Fortin, PhD

  SCF Pharma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 24, 2021
• Study Start: April 21, 2021
• Primary Completion: April 5, 2023
• Study Completion: September 14, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Locations

CA (2)