Modulation of the Brain Fog Scale by Eicosapentaenoic Acid Monoglycerides (MAG-EPA).
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19-55
SponsorSamuel Fortin
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Monoglyceride Eicosapentaenoic acid (omega-3)
Dietary supplement515 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
Other intervention698 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.
Treatment groups
48 Participants
are divided into 3 treatment groupsGroup A: Phase 1: Exploratory MAG-EPA treatment groupExperimental treatment 1 intervention
Group B: Phase 2: MAG-EPA treatment groupExperimental treatment 1 intervention
Group C: Phase 2: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
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).
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.Secondary outcomes
1
Omega-3 intake assessment by Omega-3 index analysis
Measure the subjects' omega-3 index four times during the study (Day 0, Day 28, Day 56 and Day 84 in Phase 1; Day 0, Day 56, Day 112 and Day 140 in Phase 2) to validate if the level of omega-3 index correlates with BFS scores and that the subjects in the test group adhere to the treatment. This measurement is also used to check that subjects in the placebo group are not supplemented with omega-3 during the study. Blinded personnel and subjects will not have access to the results of omega-3 index testing.
Time frame
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 2.2
Demographic data analysis
Demographic data such as age, gender, body mass index (BMI), substance use habits (alcohol, tobacco), sports habits, sleep habits as well as daily time spent using electronics will be collected to draw a detailed portrait of the studied population. These data will allow to correct for potential confounding variables in the event of an imbalance between the groups.
Time frame
From week 0 to 12 in Phase 1; From week 0 to 20 in Phase 2.3
Adverse Event reporting
Evaluate adverse events potentially related to MAG-EPA throughout the supplementation period as well as during the withdrawal period.
Time frame
From week 2 to 12 in Phase 1; From week 2 to week 20 in Phase 2.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Samuel Fortin
Lead sponsor
SCF Pharma
Sponsor institution
Institut de recherche clinique du littoral (IRCL)
Collaborator
Source ClinicalTrials.gov