Addiction problems to psychoactive substances are becoming more frequent, which implies a serious health problem, with social, family and work repercussions. Participants with chronic consumption present important degeneration processes mediated by Neuroinflammation, oxidative stress and excitotoxicity. At the moment there is no effective treatment that can reduce the damage. The effectiveness of Omega 5 has been demonstrated in different disorders of the nervous system; However, very little has been elucidated about the mechanisms of regulation and activation in consumer patients. Omega 5 Nano-PSO has an important role in mechanisms of cell survival in different pathological events. In this project aims to explain the possible mechanisms underlying the morphological changes and pathologies associated with oxidative stress and inflammation, since it could be a useful strategy to counteract the effects of substances of abuse on brain cells. Omega 5 (Nano PSO) will modify the levels of neurotrophic factors through the decrease in inflammation and reactive oxygen species in patient-consumers of substances, reducing neuronal death and therefore cognitive deterioration. Methodological design Type of study: Clinical trial, randomized controlled, double blind. Research Headquarters: This work will be carried out at the University Center for Health Science with the participation of the "My family is waiting for me" rehabilitation centers. Study Period: 2 years
Omega 5 (Nano PSO) has been shown to be a powerful antioxidant with neuroprotective and anti-inflammatory effects in various neurological and neurodegenerative diseases. In patients who consume psychoactive substances, who present high levels of neuroinflammation and oxidative stress, Omega 5 could help to reduce damage on neuronal and glial cells, promoting cell survival and preserving a homeostatic microenvironment in the brain. It has been suggested that Omega 5 could modify the levels of neurotrophic factors such as BDNF and VEGF, which might contribute to the protection of brain cells and the improvement of cognitive status in substance abuse patients. In addition, it has been mentioned that Omega 5 acts through the reduction of inflammation and reactive oxygen species, which could reduce neuronal death and prevent cognitive deterioration in these patients. In summary, Omega 5 (Nano PSO) seems to play an important role in protecting the brain cells of patients who consume psychoactive substances by acting as an antioxidant and anti-inflammatory, modulating neurotrophic factors and promoting cell survival in a brain environment affected by substance consumption. It has been investigated that Omega 5 (Nano PSO) exerts its beneficial effects through various regulation and activation mechanisms in patients who consume psychoactive substances: 1. Modulation of neurotrophic factors: It has been suggested that Omega 5 can modify the levels of neurotrophic factors such as brain-derived neurotrophic factor (BDNF) and vascular endothelial growth factor (VEGF) in patients who consume psychoactive substances. These factors play a crucial role in the neuroprotection, and its modulation by Omega 5 could contribute to the improvement of cognitive status and cell survival in these patients. 2. Antioxidant and anti-inflammatory action: Omega 5 has been shown to have antioxidant and anti-inflammatory effects in several pathologies of the nervous system. In patients who consume psychoactive substances, who have high levels of neuroinflammation and oxidative stress, Omega 5 can help reduce damage to neuronal and glial cells, promoting cell survival and preserving a homeostatic brain environment. 3. Protection against oxidative stress: It has been suggested that Omega 5 may be useful to reduce the damage caused by oxidative stress at the brain level in substance abuse patients. By acting as an antioxidant, Omega 5 could counteract the negative effects of oxidative stress on brain cells and contribute to neuronal protection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
During the intervention, Nano-PSO dietary supplement will be administered to the participants in the assigned group. Participants will be followed before and after treatment to assess the effects of Nano-PSO on cognitive status, serum concentrations of trophic factors, and other relevant parameters . This randomized, double-blind, controlled clinical trial design allows for a rigorous evaluation of the potential benefits of Nano-PSO in patients with substance use disorders. The study aims to provide valuable insights into the neuroprotective and cognitive-enhancing properties of Nano-PSO in this population.
In this arm of the study the participants will receive a placebo as a control treatment . The placebo is essential in clinical trials to compare the effects of the active intervention (Nano-PSO) with those of an inert substance.
Irene Guadalupe Aguilar García PhD.
Guadalajara, Jalisco, Mexico
RECRUITINGSerum Brain-derived neurotrophic factor (BDNF) and Vascular endothelial growth factor VEGF Concentrations after treatment
ELISA kittesting will be performed on blood samples to measure BDNF and VEGF concentrations before and after Nano PSO treatment.
Time frame: A BASELINE EVALUATION AND AN EVALUATION AFTER SIX MONTHS OF INTERVENTION
Changes in the Montreal Cognitive Assessment (MoCA) after treatment.
A neuropsychological battery will be designed to evaluate different cognitive aspects and the results of (Montreal Cognitive Assessment (MoCA) obtained will be interpreted.
Time frame: A BASELINE EVALUATION AND AN EVALUATION AFTER SIX MONTHS OF INTERVENTION
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