Eicosapentaenoic Acid Monoglycerides for Brain Fog

Modulation of the Brain Fog Scale by Eicosapentaenoic Acid Monoglycerides (MAG-EPA) in Volunteers Who Reported Suffering From Haze or Mental Fatigue on a Regular Basis. Exploratory Study (NBF-MG01).

This study is testing if a supplement called Eicosapentaenoic Acid Monoglycerides can help people who are experiencing brain fog after having COVID-19 feel better mentally.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 19 Years to 55 Years
• Sex: All
• Sponsor: SCF Pharma (industry)
• Locations: 2 sites (Maria, Quebec and 1 other locations)
• Trial ID: NCT06695910 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of Eicosapentaenoic Acid Monoglycerides (MAG-EPA) on cognitive health, particularly focusing on symptoms of brain fog, which have been reported by many individuals post-COVID-19. The study is divided into two phases: the first phase involves a single-arm treatment with eight participants, while the second phase will include 40 participants randomized into treatment and placebo groups. Participants will complete a Brain Fog Scale questionnaire to assess their cognitive health before and during the treatment period. The goal is to determine if MAG-EPA can improve cognitive function in those experiencing brain fog.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 19 to 55 who have experienced cognitive impairments such as mental fatigue and memory loss for at least 28 days.

Not a fit: Patients with normal cognitive health or those with intellectual problems that limit their ability to consent or comply with the study protocol may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve cognitive function and quality of life for patients suffering from brain fog.

How similar studies have performed: Other studies have shown promising results with omega-3 fatty acids in improving cognitive health, suggesting that this approach may be effective.

Eligibility criteria

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.

Where this trial is running

Maria, Quebec and 1 other locations

• Institut de recherche clinique du littoral (IRCL) — Maria, Quebec, Canada (RECRUITING)
• Institut de recherche clinique du littoral (IRCL) — Rimouski, Quebec, Canada (RECRUITING)

Study contacts

• Study coordinator: Samuel Fortin, Investigator, Ph.D

Conditions: Brain Fog, Cognitive Health