Clinical trial NCT04897893: Impact of 2.0g Daily of MAG-EPA on the AA/EPA Ratio and Inflammation Biomarkers in a Healthy Population Aged of 50+.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inflammation
Keywords: COX-2, Inflammation, MAG-EPA
Lead sponsor: SCF Pharma
Sponsor class: INDUSTRY
Collaborators: name: Integrated Health and Social Services Centres (CISSS) de la Gaspésie
name: Integrated Health and Social Services Centres (CISSS) du Bas-St-Laurent
First posted: 2021-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

1. 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.
2. 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.
3. 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

1. 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.
2. 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.
3. Determine the proportion of participants who achieve an omega-3 index of at least 8%.
4. 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.

Eligibility criteria: Inclusion Criteria:

1. Participant aged 50 or over.
2. 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.
3. 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.
4. Participant who has no difficulty swallowing tablets or capsules.

Exclusion Criteria:

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

Primary outcomes:
measure: Fatty acids profile analysis
timeFrame: 12 weeks
Secondary outcomes:
measure: Research of clinical biomarkers for inflammation.
timeFrame: 12 weeks
measure: Proportion of subjects with a 8% or higher omega-3 index after 12 weeks of supplementation
timeFrame: 12 weeks
measure: Impact of supplementation on proportion of senescent white blood cells.
timeFrame: 12 weeks
measure: Comparison of pre and post-dose Lipid profile.
timeFrame: 12 weeks
measure: Obsevation and research of any adverse events
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Maria
country: Canada
facility: SCF Pharma
state: Quebec
city: Rimouski
country: Canada
facility: SCF Pharma
state: Quebec
Study officials:
affiliation: SCF Pharma
name: Samuel C Fortin, PhD
role: PRINCIPAL_INVESTIGATOR
References: