Recruiting

MAG-EPA

Sponsor:

Samuel Fortin

Code:

NCT06695910

Conditions

Brain Fog

Cognitive Health

Eligibility Criteria

Sex: All

Age: 19 - 55

Healthy Volunteers: Accepted

Interventions

Monoglyceride Eicosapentaenoic acid (omega-3)

Sunflower Oil

Study Details

Brief summary:

A growing body of studies shows that omega-3s act directly in molecular signaling pathways that reduce inflammation and are thought to have a positive effect on cognitive health. Brain fog is a term that has been popularized in the medical world in the wake of the COVID-19 pandemic. A significant proportion of patients with long COVID reported having cognitive sequelae that were like fogginess. It is defined as a cognitive impairment with characteristic symptoms including problems with concentration, attention and memory, confusion, difficulty understanding what others are saying, reduced mental acuity and mental fatigue. These are episodes of reduced cognitive capacity that are not representative of the person's normal state. This condition can be caused by various factors such as stress, lack of sleep, overwork, depression, hormonal changes due to pregnancy or menopause in women, head injuries, migraine, certain diseases or viral infections, certain medications as well as substance abuse (alcohol and/or street drugs). In this study, we want to test whether omega-3 monoglycerides (MAG-EPA) can modulate the cognitive health of people with brain fog.

Conditions

Brain Fog

Cognitive Health

Study ID

NCT06695910

Start date

Nov 6, 2024

Status verified date

Dec, 2025

Completion date

Jul 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Participant between 19 and 55 years of age.
2. Participant who reports having mental fatigue and/or frequent memory loss and/or difficulty concentrating and/or inattention, confusion and/or a feeling of decreased cognitive acuity for at least 28 days at the time of selection.
3. Participant who obtains a mean score on the BFS screening questionnaires (BFS1 and BFS2) total of at least 30 and/OR who obtains the following minimum score on at least one of the three factors: Factor 1 of at least 15 and/or Factor 2 of at least 15 and/or Factor 3 of at least 12.
4. 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.
5. Absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements, ability to cooperate adequately, ability to understand and observe the instructions of the research staff.
6. Participant having no difficulty in swallowing tablets, capsules or gelcaps.

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. Participant who has used omega-3 supplements in the 30 days preceding day 1 of the study.
3. Pregnant or breastfeeding woman as declared by the latter.
4. Presence of dependence on drugs of abuse or alcohol (˃ 3 units of alcohol per day, acute or chronic excessive consumption).
5. Participant included in another clinical study and who is receiving an investigational product or other research treatment.

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Phase 1: Exploratory MAG-EPA treatment group

This is a single arm phase of the study. Every subject will receive the experimental treatment (MAG-EPA) at 1,5g/day for a period of 8 weeks.

experimental: Phase 2: MAG-EPA treatment group

This phase of the study is a parallel design. Subjects will be assigned to experimental treatment (MAG-EPA) by randomization. Every subject in this arm will receive the same treatment at 1,5g/day for a period of 16 weeks.

placebo comparator: Phase 2: Placebo group

This phase of the study is a parallel design. Subjects will be assigned to Placebo treatment (sunflower oil) by randomization. Every subject will receive the same treatment at 2,0g/day for a period of 16 weeks.

Interventions

Monoglyceride Eicosapentaenoic acid (omega-3)

515 mg MAG-EPA + 33 mg MAG-DHA per capsule x 3 capsules daily: 1.5g/day (MAG-EPA). Subjects will be treated over a period of 56 days (or 112 days in phase 2) followed by a wash-out period of 28 days.

Sunflower Oil

698 mg sunflower oil per capsule x 3 capsules: 2.0g/d sunflower oil (Placebo) Subjects will be treated over a period of 112 days followed by a wash-out period of 28 days.

Primary outcome measure

  • Cognitive health assessment with the Brain Fog Scale (BFS) [ Time Frame: Phase 1: Every two (2) weeks over a period of fourteen (14) weeks in total.Phase 2: Every two (2) weeks over a period of twenty-two (22) weeks in total. ]

Central Contacts and Locations

Central contacts

Samuel Fortin, Investigator, Ph.D

1-418-750-8590sfortin@scfpharma.com

Anne-Julie Landry, Clinical Project Manager, M.Sc, DESS

4183607480ajlandry@scfpharma.com

Locations

Institut de recherche clinique du littoral (IRCL)

Recruiting

Maria, Quebec, Canada, G0C 1Y0

Contacts

Anne-Julie Landry, Clinical Project Manager, M.Sc, DESS

418-360-7480ajlandry@ircl.ca

Institut de recherche clinique du littoral (IRCL)

Recruiting

Rimouski, Quebec, Canada, G0K 1P0

Contacts

Nancy Lemoignan, RN, ASN

nancylemoignan@hotmail.com

More Information

Sponsor

Samuel Fortin

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Samuel Fortin on 2025-12-11.