Omega-3 for Brain Fog

(NBF-MG01 Trial)

Recruiting at 1 trial location

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

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Samuel Fortin

Disqualifiers: Fish allergy, Omega-3 use, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if omega-3s, specifically monoglyceride eicosapentaenoic acid (MAG-EPA), can enhance mental clarity and alleviate brain fog symptoms. Brain fog includes difficulties such as trouble concentrating, memory lapses, and mental fatigue, often observed in individuals after COVID-19. Participants will be randomly assigned to receive either the omega-3 treatment or a placebo, with the trial lasting up to 16 weeks. Individuals experiencing frequent mental fatigue or memory issues for at least 28 days might be suitable candidates. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using omega-3 supplements, you must stop them at least 30 days before the study starts.

What is the safety track record for Monoglyceride Eicosapentaenoic acid (omega-3)?

Studies have shown that omega-3 fatty acids, such as EPA, are generally safe for use. Research indicates that omega-3 supplements rarely cause serious side effects. Many people use omega-3s for their health benefits, including improved heart health and brain function. While mild side effects like a fishy aftertaste or slight stomach upset can occur, they are uncommon and usually easy to manage. Overall, omega-3s have a strong safety record based on past research and use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Monoglyceride Eicosapentaenoic acid (MAG-EPA) for brain fog because it offers a novel approach by utilizing omega-3 fatty acids, which are known for their anti-inflammatory properties and potential cognitive benefits. Unlike standard treatments that might focus on managing symptoms with medications like stimulants or cognitive enhancers, MAG-EPA targets inflammation and brain health directly. This treatment is derived from a specific omega-3 fatty acid, eicosapentaenoic acid, in a monoglyceride form, which may enhance its absorption and effectiveness in the brain. This unique delivery method and active ingredient could offer a promising alternative or complement to existing treatments for individuals experiencing brain fog.

What evidence suggests that omega-3 might be an effective treatment for brain fog?

Research has shown that omega-3 fatty acids, such as eicosapentaenoic acid (EPA), can enhance learning, memory, and overall brain health. One study found that taking 3.36 grams of EPA and DHA daily slowed cognitive aging by 2.5 years in people with heart disease. Another study suggested that omega-3s improve thinking skills in those with mild memory issues. Omega-3s may boost learning and memory and increase blood flow to the brain. These findings offer hope that omega-3s could alleviate brain fog, a type of mental confusion. In this trial, participants will receive Monoglyceride Eicosapentaenoic acid (MAG-EPA) to explore its potential benefits for brain fog. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing 'brain fog' with symptoms like trouble concentrating, memory issues, and mental fatigue. It's not specified who can't join the trial, but typically those with certain medical conditions or taking medications that could interfere might be excluded.

Inclusion Criteria

Participant having no difficulty in swallowing tablets, capsules or gelcaps

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

I am between 19 and 55 years old.

Exclusion Criteria

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

Known allergy or intolerance to fish or history of allergic reactions attributable to fish, or to a compound similar to fish oil

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment Phase 1

Participants receive MAG-EPA treatment at 1.5g/day for 8 weeks

8 weeks

4 visits (in-person), 3 visits (telephone follow-up)

Wash-out

Participants undergo a wash-out period with no treatment

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Monoglyceride Eicosapentaenoic acid (omega-3)

Trial Overview The study tests if omega-3 monoglycerides (MAG-EPA), which may reduce inflammation and improve cognitive health, can help people with brain fog. Participants will also receive sunflower oil as a comparison.

How Is the Trial Designed?

Group I: Phase 2: MAG-EPA treatment group Experimental Treatment 1 Intervention

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.

Group II: Phase 1: Exploratory MAG-EPA treatment group Experimental Treatment 1 Intervention

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.

Group III: Phase 2: Placebo group Placebo Group 1 Intervention

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.

Monoglyceride Eicosapentaenoic acid (omega-3) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Vascepa for:

• Hypertriglyceridemia
• Heart disease
• Depression

Approved in European Union as Eicosapentaenoic acid for:

• Hypertriglyceridemia
• Heart disease

Approved in Canada as MAG-EPA for:

• General health and wellness
• Heart health

Who Is Running the Clinical Trial?

Samuel Fortin

Lead Sponsor

Trials

3

Recruited

90+

Institut de recherche clinique du littoral (IRCL)

Collaborator

Trials

3

Recruited

100+

Published Research Related to This Trial

A study using Long Evans rats showed that eicosapentaenoic acid (EPA) significantly contributes to the turnover of docosahexaenoic acid (DHA) in the brain, indicating its potential role in maintaining brain DHA levels.

After 8 weeks of dietary intervention, EPA was primarily converted to phosphatidylethanolamine (PE) in the liver and accumulated in the brain, suggesting that EPA supplementation could be beneficial for brain health and possibly for managing symptoms of major depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma unesterified eicosapentaenoic acid is converted to docosahexaenoic acid (DHA) in the liver and supplies the brain with DHA in the presence or absence of dietary DHA. Metherel, AH., Rezaei, K., Lacombe, RJS., et al.[2021]

Omega-3 polyunsaturated fatty acids (PUFAs) have been linked to various health benefits, including positive effects on cardiovascular disease, diabetes, and mental health conditions like depression, based on numerous epidemiological studies.

Despite the reported benefits, there are ongoing debates regarding the efficacy of omega-3 PUFAs for certain health outcomes, highlighting the need for further research to clarify their role in human health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 Polyunsaturated Fatty Acids and Their Health Benefits. Shahidi, F., Ambigaipalan, P.[2019]

Alzheimer's disease is linked to imbalances in brain lipids and the accumulation of amyloid-β, which leads to neuronal damage and cognitive decline.

Medium chain fatty acids (MCFAs) and omega-3 polyunsaturated fatty acids (ω-3-PUFAs) may help improve brain health by reducing amyloid-β deposition and oxidative stress, potentially benefiting patients with mild cognitive impairment and Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Medium Chain and Polyunsaturated ω-3-Fatty Acids on Amyloid-β Deposition, Oxidative Stress and Metabolic Dysfunction Associated with Alzheimer's Disease. Mett, J.[2021]

Alzheimer's disease (AD) is linked to lower levels of omega-3 fatty acids, particularly DHA, in both plasma and specific brain regions, indicating a potential dietary influence on the disease.

The study found significant differences in fatty acid profiles between individuals with AD, mild cognitive impairment (MCI), and those with no cognitive impairment (NCI), suggesting that altered fatty acid metabolism may play a role in the progression of cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma and brain fatty acid profiles in mild cognitive impairment and Alzheimer's disease. Cunnane, SC., Schneider, JA., Tangney, C., et al.[2022]

Diets lacking omega-3 polyunsaturated fatty acids (PUFA) can significantly disrupt brain function, but these effects can often be reversed by reintroducing omega-3 PUFA, highlighting their importance for neural health.

Recent clinical studies suggest that omega-3 PUFA, particularly docosahexaenoic acid (DHA), may be beneficial in treating neuropsychological disorders like depression, with complex mechanisms of action beyond just affecting cell membrane properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega 3 fatty acids and the brain: review of studies in depression. Sinclair, AJ., Begg, D., Mathai, M., et al.[2007]

A systematic review of nine randomized clinical trials involving 1319 participants found that omega-3 fatty acids significantly enhance cognitive functions such as learning and memory, as well as improve blood flow in the brain.

Omega-3 treatments were shown to be well-tolerated and risk-free, making them a beneficial option, especially for individuals who are lonelier, elderly, or have diets low in healthy omega-3 sources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Omega-3 Polyunsaturated Fatty Acids on Brain Functions: A Systematic Review. Dighriri, IM., Alsubaie, AM., Hakami, FM., et al.[2022]

Mice fed a canola:soybean oil diet showed significant changes in brain fatty acid profiles, including increased oleic acid and docosahexaenoic acid (DHA), which are linked to improved neuronal function in the entorhinal cortex.

This dietary change resulted in enhanced neuronal firing activity and shorter action potentials, suggesting that canola oil-based diets may positively influence learning and memory by modifying the intrinsic properties of neurons in the entorhinal-hippocampal circuit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary intake of unsaturated fatty acids modulates physiological properties of entorhinal cortex neurons in mice. Arsenault, D., Julien, C., Chen, CT., et al.[2018]

The 2010 NIH State of the Science Conference found insufficient evidence to recommend any primary prevention therapy for Alzheimer's disease, including omega-3 fatty acids (n-3 LC-PUFA), despite public interest and use.

Epidemiological data suggest that low intake of n-3 LC-PUFA is associated with a higher risk of cognitive decline, but clinical trials have not specifically targeted these at-risk populations, indicating a gap in research that needs to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current evidence for the clinical use of long-chain polyunsaturated n-3 fatty acids to prevent age-related cognitive decline and Alzheimer's disease. Dacks, PA., Shineman, DW., Fillit, HM.[2021]

A lower concentration of eicosapentaenoic acid (EPA) in the blood was identified as a significant risk factor for ischemic stroke in a study involving 130 participants (65 with stroke and 65 controls).

The study also found that a lower EPA/arachidonic acid (AA) ratio and lower body mass index were significant risk factors specifically for the cardioembolism subtype of ischemic stroke, suggesting that monitoring these factors could help in stroke prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of eicosapentaenoic acid concentrations in plasma between patients with ischemic stroke and control subjects. Ikeya, Y., Fukuyama, N., Kitajima, W., et al.[2022]

Observational studies suggest that higher intake of fish or DHA is linked to lower cognitive impairment, but intervention studies in healthy older adults have not shown significant benefits from EPA and DHA supplementation over two years.

While supplementation with EPA and DHA appears to have positive effects in individuals with mild cognitive impairment, it does not seem to benefit those with established Alzheimer's disease, indicating that timing and patient selection may be crucial for efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ω-3 fatty acids in the prevention of cognitive decline in humans. Cederholm, T., Salem, N., Palmblad, J.[2023]

Long-term use of omega-3 fatty acid supplements was associated with a 64% reduced risk of developing Alzheimer's disease in a study of 1,135 participants over 6 years.

A meta-analysis of 48 studies involving over 103,000 participants indicated that dietary intake of omega-3 fatty acids could lower the risk of all-cause dementia or cognitive decline by approximately 20%, particularly highlighting the benefits of docosahexaenoic acid (DHA).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relationship of Omega-3 Fatty Acids with Dementia and Cognitive Decline: Evidence from Prospective Cohort Studies of Supplementation, Dietary Intake, and Blood Markers. Wei, BZ., Li, L., Dong, CW., et al.[2023]

Observational studies suggest that omega-3 fatty acids, particularly DHA, may have beneficial effects on cognition and could help prevent Alzheimer's disease, although results are inconsistent.

Recent randomized studies did not show overall positive effects of omega-3 fatty acids on cognitive decline, but some individuals with mild Alzheimer's may benefit, indicating that these fatty acids could serve as an adjuvant therapy in specific cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are omega-3 fatty acids options for prevention and treatment of cognitive decline and dementia? Cederholm, T., Palmblad, J.[2013]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06695910/modulation-of-the-brain-fog-scale-by-eicosapentaenoic-acid-monoglycerides-mag-epa

Modulation of the Brain Fog Scale by Eicosapentaenoic ... In this study, we want to test whether omega-3 monoglycerides (MAG-EPA) can alter the cognitive health of people with brain fog. Read more ...

2. withpower.com withpower.com/trial/omega-3-for-brain-fog-14818

Omega-3 for Brain Fog (NBF-MG01 Trial) Research shows that omega-3 fatty acids, including eicosapentaenoic acid (EPA), can improve learning, memory, and overall brain health. Long-term use of omega-3 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36637075/

Omega-3 fatty acids and cognitive function - PubMed - NIH In cognitively healthy individuals with clinical coronary artery disease (CAD), 3.36 g EPA and DHA daily slowed cognitive ageing by 2.5 years.

4. sciencedirect.com sciencedirect.com/science/article/pii/S156816372200277X

New perspectives on randomized controlled trials with ... Cognition of people with mild cognitive impairments could benefit from an omega-3 fatty acid supplement. •. A better rationale and justification of the research ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9641984/

Effects of Omega-3 Polyunsaturated Fatty Acids on Brain ... Ingestion of omega-3 fatty acids increases learning, memory, cognitive well-being, and blood flow in the brain.

6. ods.od.nih.gov ods.od.nih.gov/factsheets/Omega3FattyAcids-HealthProfessional/

Omega-3 Fatty Acids - Health Professional Fact Sheet Omega 3 fatty acids overview for health professionals. Research health effects, dosing, sources, deficiency, side effects, and interactions here.