Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institut de recherche clinique du littoral (IRCL) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
The study is divided into two phases. The first will include eight (8) subjects and all will receive the study treatment (MAG-EPA). This is a single arm phase. If signs of improvement in cognitive health are perceived in Phase 1, the study may continue with Phase 2.
Phase two will include forty (40) participants divided into two treatment groups. Assignment to any of the treatment groups will be done by randomization. This phase will be double-blind and controlled by placebo.
Participants will be asked to complete a Brain Fog Scale (BFS) questionnaire at Visit 0, immediately after signing the informed consent form. This questionnaire covers the 14 days preceding Visit 0. The subject will be asked to complete the BFS again at Visit 1, which should take place 14 days after Visit 0. These two questionnaires will provide a self-declared state of the participant's cognitive health in the 28 days preceding the start of treatment. The results of the first two questionnaires (BFS1 and BFS2) will determine whether the participant's cognitive state is severe enough to be eligible for participation in the study. Indeed, an exclusion criterion was written in the protocol to avoid including participants with normal cognitive health. Once enrolled in the study, subjects will be required to complete a BFS every 14 days until day 140, that is to say at each visit as well as at each telephone follow-up in between visits (V1, day 0; T1, day 14; V2, day 28; T2, day 42; V3, day 56; T3, day 70; V4, day 84; T4, day98; V5, day 112; T5, day 126 and V6, day 140).
Treatment will be given to each subject, MAG-EPA in phase 1 or either MAG-EPA or placebo (sunflower oil) in phase 2, to be taken daily from day 0 to day 112 (112 consecutive days in total, also corresponding to 16 weeks of treatment). Every subject will take 3 gelcaps daily for a total dose of 1.5g/day of MAG-EPA or 2.0g/day of sunflower oil. A wash-out period of 28 days, form day 112 to day 140, will follow treatment.
For research purposes, the Omega-3 Index will be measured from blood samples collected at Visit 1, 3, 5 and 6. The Omega-3 Index is a quantitative analysis that measures the blood level of Omega-3. This test is used both to confirm the adherence of subjects to treatment (for all subjects in Phase 1 as well as for the test group in Phase 2) and to control the restriction of Omega-3 in subjects in the control group (the placebo treatment in Phase 2). The Omega-3 Index results are indicative of the treatment received for each subject, therefore, the analysis reports will not be given to research staff who are blinded.
Demographic information will also be noted for every subject to better characterise the study population in each group.
Any adverse change to subject's health will be noted and followed until resolution or other final outcome.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive health assessment with the Brain Fog Scale (BFS) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de recherche clinique du littoral (IRCL) | Recruiting | Maria | Quebec | G0C 1Y0 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
Not provided
Not provided
Sharing participant data require subject consent for sharing. We do not plan to recontact study subjects for data sharing consent.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005222 | Mental Fatigue |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C588285 | 1-eicosapentaenoylglycerol |
| D004281 | Docosahexaenoic Acids |
| D000074242 | Sunflower Oil |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
|
| 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. |
|
|
| 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 | 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. | From week 0 to 12 in Phase 1; From week 0 to 20 in Phase 2. |
| Adverse Event reporting | Evaluate adverse events potentially related to MAG-EPA throughout the supplementation period as well as during the withdrawal period. | From week 2 to 12 in Phase 1; From week 2 to week 20 in Phase 2. |
| Institut de recherche clinique du littoral (IRCL) | Recruiting | Rimouski | Quebec | G0K 1P0 | Canada |
|
| D001519 | Behavior |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |