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RECRUITING
NCT06520878
PHASE2

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

Sponsor: Distribuidora Biolife SA de CV

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-02-12

Completion Date

2025-12-01

Last Updated

2025-02-06

Healthy Volunteers

No

Conditions

Interventions

DIETARY_SUPPLEMENT

NANO-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_SUPPLEMENT

Placebo

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