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).

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 55
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Canada
Institut de recherche clinique du littoral (IRCL)
RECRUITING
Maria
Institut de recherche clinique du littoral (IRCL)
RECRUITING
Rimouski
Contact Information
Primary
Samuel Fortin, Investigator, Ph.D
sfortin@scfpharma.com
1-418-750-8590
Backup
Anne-Julie Landry, Clinical Project Manager, M.Sc, DESS
ajlandry@scfpharma.com
4183607480
Time Frame
Start Date: 2024-11-06
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 48
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Institut de recherche clinique du littoral (IRCL)
Leads: Samuel Fortin

This content was sourced from clinicaltrials.gov