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

NCT ID: NCT04897893

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-21

Study Completion Date

2023-09-14

Brief Summary

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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

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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.

Conditions

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Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental Treatment

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.

Group Type EXPERIMENTAL

Eicosapentaenoic acid monoglycerid (MAG-EPA)

Intervention Type 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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Integrated Health and Social Services Centres (CISSS) de la Gaspésie

UNKNOWN

Sponsor Role collaborator

Integrated Health and Social Services Centres (CISSS) du Bas-St-Laurent

UNKNOWN

Sponsor Role collaborator

SCF Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel C Fortin, PhD

Role: PRINCIPAL_INVESTIGATOR

SCF Pharma

Locations

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SCF Pharma

Maria, Quebec, Canada

Site Status

SCF Pharma

Rimouski, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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IO3-04

Identifier Type: -

Identifier Source: org_study_id