Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment (COGMEG5)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognition
• Intervention / Treatment: Dietary supplement: NANO-PSO (pomegranate seed oil); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alejandro Padilla Isassi, Geriatrician and researcher; Phone Number: +525589510727; Email: alejandropadillaisassi@gmail.com
• Study Contact Backup: Name: Abraham Samra Saad, Geriatrician and researcher; Phone Number: +525589510727; Email: abrahamsamra@gmail.com

Study Locations

• Mexico
  • Cdmx
    • Miguel Hidalgo, Cdmx, Mexico, 11520
      • Recruiting
      • Hospital Español. Av Ejercito Nacional 613, Miguel Hidalgo, CDMX, 11520
      • Contact: Alejandro Padilla Isassi, Geriatrician; Phone Number: 5625592234; Email: alejandropadillaisassi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients attended at the Hospital Español.
• Patients of any gender who are 60 years or older.
• Patients presenting with mild to moderate cognitive impairment.
• Meet the diagnostic criteria for "probable dementia" of the National Institute on Aging and the Alzheimer's Association (NIA-AA) (2011).
• Meet the criteria for the typical variant of Alzheimer's disease, specifically a specific clinical phenotype.
• Progressive and gradual change in memory functions reported by the patient or the informant for at least 6 months.
• Objective evidence of a hippocampal-type amnesic syndrome, based on significant impairment in the performance of episodic memory tests with established specificity for AD.
• Subjects are primary and secondary school graduates and have the ability to complete cognitive capacity tests and other specified tests in the program.
• Total score on the Hachinski Ischemic Scale (HIS) ≤ 4.
• Patients who sign the informed consent.

Exclusion Criteria:

• Patients with known allergy to any component of the NANO-PSO capsule (e.g., fish).
• Patients with short bowel syndrome, bariatric surgery, or gluten reaction that may affect intestinal absorption.
• Patients in palliative care with a life expectancy of less than 6 months according to the NECPAL scale.
• Patients with terminality criteria established in the comprehensive palliative care management guide of Mexico.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NANO-PSO; 640 mg of NANO-PSO (pomegranate seed oil)	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.; Other Names: Granagard; Omega 5
Placebo Comparator: Mineral oil; 640 mg of mineral oil	Dietary supplement: Placebo; Placebo administered orally, 2 capsules, equivalent to 640 mg of mineral oil, every 24 hours in the morning with food.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive status assessment	Cognitive status assessment using the Mini-Mental State Examination, which ranges from 0 to 30 points and the higher score is better with higher cognition	Assessed at baseline, 3, and 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Selective attention and processing speed	Selective attention and processing speed will be evaluated using the Trail Making Test (TMT), where the average time for TMT Part A is 29 seconds, with more than 78 seconds being considered deficient. For TMT Part B, the average time is 75 seconds, and more than 273 seconds is considered deficient.	Assessed at baseline, 3, and 6 months.
Frailty	Frailty will be assessed using the Fried Frailty Criteria (Phenotype Model), which comprises five criteria. Based on these criteria. 0 criteria = No frailty; 1 to 2 criteria = Pre-frailty; 3 or more criteria = Frailty	Assessed at baseline, 3, and 6 months.
Patients' fatigue status	Evaluation using the 9-item Fatigue Severity Scale, which measures the severity of fatigue and its impact on the daily activities and lifestyle of patients. The scale ranges from 9 to 63 points and the higher the score, the worse the feeling of fatigue	Assessed at baseline, 3, and 6 months.

Collaborators and Investigators

• Sponsor: Distribuidora Biolife SA de CV
• Investigators: Principal Investigator: Alejandro Padilla Isassi, Geriatrician and researcher, Distribuidora Biolife S.A. de C.V.

Publications and helpful links

General Publications

• Binyamin O, Nitzan K, Frid K, Ungar Y, Rosenmann H, Gabizon R. Brain targeting of 9c,11t-Conjugated Linoleic Acid, a natural calpain inhibitor, preserves memory and reduces Abeta and P25 accumulation in 5XFAD mice. Sci Rep. 2019 Dec 5;9(1):18437. doi: 10.1038/s41598-019-54971-9. Erratum In: Sci Rep. 2020 Jan 23;10(1):1320. doi: 10.1038/s41598-020-58232-y.

Study record dates

Study Major Dates

• Study Start (Estimated): February 12, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 20, 2024
• First Submitted That Met QC Criteria: July 20, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Antioxidants; Supplementation; Cognitive impairment; NANO-PSO; Omega 5
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: ENS-2024-TL001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Sharing the information has not been considered or thought of due to the confidentiality statuses of the Hospital Español

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No