Irene Guadalupe Aguilar García PhD.
Guadalajara, Jalisco, Mexico
Location status: Recruiting
NCT Number: NCT06550167
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
Interested in participating?
Request Info18 year–50 year
Male
Interventional
Not applicable
Guadalajara, Jalisco, Mexico
Location status: Recruiting
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Oil of pomegranate seed with nanotechnology
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.
Time frame: A BASELINE EVALUATION AND AN EVALUATION AFTER SIX MONTHS OF INTERVENTION
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
A neuropsychological battery will be designed to evaluate different cognitive aspects and the results of (Montreal Cognitive Assessment (MoCA) obtained will be interpreted.
Contact information is provided by the study sponsor or research team.
Irene G Aguilar, PH
CONTACT
Rolando Castañeda, PH
CONTACT
Distribuidora Biolife SA de CV
Industry
Neuroprotective Effect of Omega (Nano PSO), Changes in Neurotrophic BDNF and VEGF, and Their Association With Cognitive Status in Patients Who Used to Consume Psychoactive Substances
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