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

About this trial

Last updated 5 months ago

Study ID

NBF-MG01

Status

Recruiting

Type

Interventional

Phase

Phase 4

Placebo

Accepting

19 to 55 Years

All Sexes

Trial Timing

Started 2 years ago

What is this trial about?

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.

What are the participation requirements?

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.