Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment
ConditionCognition
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorDistribuidora Biolife SA de CV
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
NANO-PSO (pomegranate seed oil)
Dietary supplementNANO-PSO administered orally, 2 capsules, equivalent to 640 mg of pomegranate seed oil, every 24 hours in the morning with food.
Placebo
Dietary supplementPlacebo administered orally, 2 capsules, equivalent to 640 mg of mineral oil, every 24 hours in the morning with food.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: NANO-PSOExperimental treatment 1 intervention
Group B: Mineral oilPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Assessed at baseline, 3, and 6 months.Secondary outcomes
1
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
Time frame
Assessed at baseline, 3, and 6 months.2
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.
Time frame
Assessed at baseline, 3, and 6 months.3
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
Time frame
Assessed at baseline, 3, and 6 months.Sponsors and contacts
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Source ClinicalTrials.gov