Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT04897893
Status:
COMPLETED
Last Update Posted:
2023-11-27
First Post:
2021-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of 2.0g Daily of MAG-EPA on the AA/EPA Ratio and Inflammation Biomarkers in a Healthy Population Aged of 50+.
Sponsor:
SCF Pharma
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IO3-04
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: