RecruitingPhase 2NCT06520878

Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment

Impact of NANO-PSO (omega 5) Supplementation on Cognitive Abilities of Older Adults with Mild to Moderate Non-vascular Cognitive Impairment


Sponsor

Distribuidora Biolife SA de CV

Enrollment

60 participants

Start Date

Feb 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this randomized, triple-blind, placebo-controlled clinical trial is to compare NANO-PSO therapy against placebo in improving cognitive abilities in older adults with mild to moderate non-vascular cognitive impairment over six months of treatment. The primary questions it aims to answer are: • Does NANO-PSO therapy improve cognitive abilities in older adults with mild to moderate non-vascular cognitive impairment over six months of treatment compared to placebo? The researchers will compare NANO-PSO therapy against placebo to see if it benefits the cognitive abilities of geriatric patients. Participants will be required to: * Consume two capsules of NANO-PSO or placebo daily in the morning for six months. * Be evaluated monthly by phone to identify potential risks and ensure adherence to the treatment. * Be evaluated in person at 90 and 180 days of treatment. * The patient or primary caregiver must maintain a log to confirm daily dose consumption and will have a direct communication line with the attending physicians in case of questions about ingestion or possible adverse reactions. * At the end of the final patient evaluation, a quality questionnaire will be administered.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying NANO-PSO (pomegranate seed oil) and Placebo for people with cognition. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTNANO-PSO (pomegranate seed oil)

NANO-PSO administered orally, 2 capsules, equivalent to 640 mg of pomegranate seed oil, every 24 hours in the morning with food.

DIETARY_SUPPLEMENTPlacebo

Placebo administered orally, 2 capsules, equivalent to 640 mg of mineral oil, every 24 hours in the morning with food.


Locations(1)

Hospital Español. Av Ejercito Nacional 613, Miguel Hidalgo, CDMX, 11520

Miguel Hidalgo, Mexico City, Mexico

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NCT06520878


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