Modulation of the Brain Fog Scale by Eicosapentaenoic Acid Monoglycerides (MAG-EPA).

NCT06695910 | Recruiting Phase 4

• 1 other identifier: NBF-MG01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Cognitive health assessment with the Brain Fog Scale (BFS)

  * Evaluate the brain fog of all subjects using the Brain Fog Scale (BFS) before the start of treatment, then every 14 days over a period of 98 days (BFS 1 to 8) in phase 1 or a period of 154 days in phase 2 (BFS 1 to 12). * For each BFS measured after the start of treatment (BFS 3 to 8 in phase 1 or BFS 3 to 12 in phase 2), compare the score of each individual factor (Factor 1: mental fatigue; Factor 2: impaired cognitive acuity; Factor 3: confusion) with that obtained at the pre-treatment BFS measures (BFS 1 and 2). * For each BFS measured after the start of treatment (BFS 3 to 8 in phase 1 or BFS 3 to 12 in phase 2), compare the total score with that obtained at the pre-treatment BFS measures (BFS 1 and 2).

  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.

Secondary Outcomes (3)

• Omega-3 intake assessment by Omega-3 index analysis

  At 0, 4, 8 and 12 weeks in phase 1; At 0, 8, 16 and 20 weeks after the start of the study in Phase 2.

• Demographic data analysis

  From week 0 to 12 in Phase 1; From week 0 to 20 in Phase 2.

• Adverse Event reporting

  From week 2 to 12 in Phase 1; From week 2 to week 20 in Phase 2.

Study Arms (3)

Phase 1: Exploratory MAG-EPA treatment group

EXPERIMENTAL

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.

Dietary Supplement: Monoglyceride Eicosapentaenoic acid (omega-3)

Phase 2: MAG-EPA treatment group

EXPERIMENTAL

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.

Dietary Supplement: Monoglyceride Eicosapentaenoic acid (omega-3)

Phase 2: Placebo group

PLACEBO COMPARATOR

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.

Other: Sunflower Oil

Interventions

Monoglyceride Eicosapentaenoic acid (omega-3) DIETARY_SUPPLEMENT

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.

Also known as: MAG-EPA

Phase 1: Exploratory MAG-EPA treatment group; Phase 2: MAG-EPA treatment group

Sunflower Oil OTHER

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.

Also known as: Placebo

Phase 2: Placebo group

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant between 19 and 55 years of age.
• 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.
• 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.
• 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.
• 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.
• Participant having no difficulty in swallowing tablets, capsules or gelcaps.

You may not qualify if:

• Known allergy or intolerance to fish or history of allergic reactions attributable to fish, or to a compound similar to fish oil.
• Participant who has used omega-3 supplements in the 30 days preceding day 1 of the study.
• Pregnant or breastfeeding woman as declared by the latter.
• Presence of dependence on drugs of abuse or alcohol (˃ 3 units of alcohol per day, acute or chronic excessive consumption).
• Participant included in another clinical study and who is receiving an investigational product or other research treatment.

Sponsors & Collaborators

• Samuel Fortin: lead
• Institut de recherche clinique du littoral (IRCL): collaborator

Study Sites (2)

Institut de recherche clinique du littoral (IRCL)

Maria, Quebec, G0C 1Y0, Canada

RECRUITING

Institut de recherche clinique du littoral (IRCL)

Rimouski, Quebec, G0K 1P0, Canada

RECRUITING

Related Publications (1)

• Agata Debowska, Daniel Boduszek, Marek Ochman, Tomasz Hrapkowicz, Martyna Gaweda, Anastazja Pondel, Beata Horeczy, Brain Fog Scale (BFS): Scale development and validation, Personality and Individual Differences Volume 216, 2024, 112427, ISSN 0191-8869.

  BACKGROUND

MeSH Terms

Conditions

Mental Fatigue

Interventions

1-eicosapentaenoylglycerol; Docosahexaenoic Acids; Sunflower Oil

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Central Study Contacts

Samuel Fortin, Investigator, Ph.D

CONTACT

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

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

CONTACT

4183607480; ajlandry@scfpharma.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President

Model Details: The study is divided in two phases. Phase 1: Single arm. 8 subjects treated with MAG-EPA over a period of 56 days followed by a 28 days wash-out period. Phase 2: Two arms, placebo controlled, double-blind study. 40 subjects are assigned either to MAG-EPA or Placebo (sunflower oil) and are treated over a 112 days period followed by a 28 days wash-out period.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)