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

NCT06520878 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-06

No results posted yet for this study

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.

Conditions

  • Cognition

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.

Sponsors & Collaborators

  • Distribuidora Biolife SA de CV

    lead INDUSTRY

Principal Investigators

  • Alejandro Padilla Isassi, Geriatrician and researcher · Distribuidora Biolife S.A. de C.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-12
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06520878 on ClinicalTrials.gov