Neuroprotective Effect of (Nano PSO), in Patients Who Used to Consume Psychoactive Substances

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Пищевая добавка Nano-PSO, Pomegranate seed oil (omega-5)
  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 pr
• Другое PLACEBO
  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.

Первичные конечные точки

• Serum Brain-derived neurotrophic factor (BDNF) and Vascular endothelial growth factor VEGF Concentrations after treatment [Срок оценки: A BASELINE EVALUATION AND AN EVALUATION AFTER SIX MONTHS OF INTERVENTION]

Вторичные конечные точки (1)

• Changes in the Montreal Cognitive Assessment (MoCA) after treatment. [Срок оценки: A BASELINE EVALUATION AND AN EVALUATION AFTER SIX MONTHS OF INTERVENTION]

Критерии участия

Критерии включения

• Patients who are multiple users of methamphetamines, cocaine, and cannabis with or without alcohol and tobacco, and have a history of at least 3 years of consumption.
• Patients who accept informed consent to participate in the protocol.
• Male gender.
• Age between 18-50 years in the withdrawal phase currently in residential treatment

Критерии исключения

• Individuals under 18 years of age.
• Patients who do not sign the informed consent.
• Discharge of patients prior to the stipulated 6 months, requested by family members.
• Patients with developed or known allergies.
• Patients who are consuming NSAIDs, MAOIs (monoamine oxidase Inhibitor), active chronic inflammatory diseases, or any type of cancer

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• Irene Guadalupe Aguilar García PhD. — Guadalajara

Публикации

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• Berrios-Carcamo P, Quezada M, Quintanilla ME, Morales P, Ezquer M, Herrera-Marschitz M, Israel Y, Ezquer F. Oxidative Stress and Neuroinflammation as a Pivot in Drug Abuse. A Focus on the Therapeutic Potential of Antioxidant and Anti-Inflammatory Agents and Biomolecules. Antioxidants (Basel). 2020 Sep 4;9(9):830. doi: 10.3390/antiox9090830. PMID 32899889
• Castillo-Navarrete JL, Guzman-Castillo A, Bustos C, Rojas R. Peripheral brain-derived neurotrophic factor (BDNF) and salivary cortisol levels in college students with different levels of academic stress. Study protocol. PLoS One. 2023 Feb 22;18(2):e0282007. doi: 10.1371/journal.pone.0282007. eCollection 2023. PMID 36812175
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Идентификаторы

NCT: NCT06550167 · 23-122

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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