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

August 9, 2024 updated by: Irene Guadalupe Aguilar García, Distribuidora Biolife SA de CV

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nano-PSO
Nano-PSO or Pomegranate seed oil with nanotechnology, capsules with a net content of 640mg with a dosage indicated by sponsor of 2 capsules in fast
Dietary supplement: 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 provide valuable insights into the neuroprotective and cognitive-enhancing properties of Nano-PSO in this population.

Other Names:
  • Oil of pomegranate seed with nanotechnology
Placebo Comparator: PLACEBO
Placebo physically identical to Nano-PSO capsules Soft gelatin capsules 640 mg edible oil for PLACEBO being the following information: oil edible, oval shape, 640 mg
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Brain-derived neurotrophic factor (BDNF) and Vascular endothelial growth factor VEGF Concentrations after treatment
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.
A BASELINE EVALUATION AND AN EVALUATION AFTER SIX MONTHS OF INTERVENTION

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Montreal Cognitive Assessment (MoCA) after 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.
A BASELINE EVALUATION AND AN EVALUATION AFTER SIX MONTHS OF INTERVENTION

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Distribuidora Biolife SA de CV

Investigators

  • Principal Investigator: Irene G Aguilar, PH, University of Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2024

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

March 15, 2027

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

August 9, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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