SCF Pharma NCT06695910

NBF-MG01; Interventional - Natural Health Product

Modulation of the Brain Fog Scale by monoglycerides of eicosapentaenoic acids (MAG-EPA) in volunteers reporting regular mental fog or fatigue. Exploratory study (NBF-MG01).

Head Trauma/Stroke Mental fog Cognitive Inflammation

Summary

This study is the first in SCF Pharma’s cognitive health research axis. It aims to evaluate the potential of eicosapentaenoic acid monoglycerides (MAG-EPA) in the form of supplements to modulate the Brain Fog Scale in volunteers claiming to suffer from brain fog or mental fatigue on a regular basis. A first cohort of eight participants will be recruited at the Maria site. Subsequently, the study will expand to the Rimouski site to recruit 40 additional participants distributed between the two research sites. The volunteers' participation extends over a period of twenty-two (22) weeks in total.

Description

Fatty acids are the basic building blocks of fats found in all living organisms. The essential fatty acids are divided into two main categories: omega-3 and omega-6. These oils are naturally present almost everywhere in consumer products. They oppose each other in their mechanism of action at the molecular level. It is widely recognized in the scientific literature that omega-3s have anti-inflammatory properties as opposed to omega-6s which have mechanisms of action that promote inflammation. During research in the field, it has been indirectly observed that EPA (Eicosapentaenoic Acid) omega-3s offer beneficial effects in terms of mood, fatigue, and cognitive health. The mechanism of action at the molecular level as well as the direct link remain to be demonstrated by additional studies. Some research teams believe that temporary problems with cognitive health may be linked to neuroinflammation. The anti-inflammatory action of EPA could act at this level. SCF Pharma, which specializes in pre-activated omega-3 oils (monoglycerides or MAG), dedicates part of its research program to cognitive health.

Omega-3 monoglycerides (MAG-O3) developed by SCF Pharma are a new generation of omega-3s that are believed to be more effective due to their better absorption by the body. Omega-3s are generally ingested as dietary supplements in the form of ethyl esters which require several steps of metabolization before they can be absorbed by the tissues. Monoglycerides (MAG) are the final form of these metabolization steps. MAG-03 acts at the cellular level to activate the production of SPM (specialized pro-resolution mediators) which are key players against inflammation. Through their anti-inflammatory action, Omega-3 monoglycerides have a potential in treating Brain fog/mental fatigue that needs to be explored.

The recent COVID-19 pandemic has brought the phenomenon of brain fog into the spotlight as thousands of patients worldwide have described it as one of the main symptoms of long COVID. Brain fog 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 acuity that are not representative of the person's normal state. These episodes can be caused by various factors such as stress, lack of sleep, overwork, depression, hormonal changes due to pregnancy or menopause in women, head trauma, migraine, certain diseases or viral infections, certain medications as well as substance abuse (alcohol and/or street drugs). 

The Brain Fog Scale (BFS) is a psychometric tool that measures brain fog quantitatively. Therefore, the BFS allows for comparison of inter- and intra-individual results in a clinical or research setting. The aim of this study is to evaluate the potential of the MAG-EPA to modulate BFS in participants reporting regular episodes of brain fog.

Sponsor

SCF Pharma

Open to recruitment
Last modification:
2025-06-11
Research sites
IRCL Rimouski, IRCL Maria
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