Phosphatidylserine Improves Cognitive Function in the Elderly (PICFITE)

Clinical Study on the Effect of Phosphatidylserine on Cognitive Function Improvement in the Elderly

Cognitive decline is a common symptom of aging, and age-related cognitive impairments are considered normal or inevitable, especially in people over 60, whose memory is more likely to be affected by age. As life expectancy has increased, the number of people with age-related cognitive impairment has also increased. The improvement or slowing of cognitive impairment has received more attention. Phosphatide is a naturally occurring Phosphatide, but it is the main acidic phospholipid in the brain. Phosphatidylserine (PS) is a phospholipid that regulates the function of key proteins in cell membranes and can improve brain function and repair brain damage. PS is thought to enhance neuronal membrane function, which in turn enhances cognitive function. However, there are few studies on the effect of PS on human cognitive function, especially on the elderly, and the results are inconsistent. In this study, people aged 60-70 were given PS intervention for 6 months. Montreal Cognitive Assessment (MOCA) and Mini-Mental State Examination.MMSE) and head MRI are used to evaluate the cognitive function of the subjects before and after the intervention to observe the influence of PS on the cognitive function of the elderly, which is of certain significance for the accurate assessment of the cognitive function of the elderly population and the improvement of the cognitive function of the elderly.

Study Overview

• Status: Not yet recruiting
• Conditions: Aging
• Intervention / Treatment: Dietary supplement: Phosphatidylserine; Dietary supplement: Bean powder

Detailed Description

This is a randomized, controlled, double-blind clinical trial, in which 100 subjects were randomly assigned to the treatment group and the control group 1:1 by computer generated random numbers. Before start of the study, all the subjects underwent the first magnetic resonance (MR) and electroencephalogram (EEG) data collection. The working memory capacity of subjects in the N-back paradigm was measured (collected during the N-back task in the EEG test), and the cognition was measured by MOCA and MMSE. After the first data collection was completed, subjects in the treatment group oral the PS (600mg/d, q.d.) for 6 months. Subjects in the control group were given a placebo, which was the same shape of bean powder(600mg/d, q.d.). Under the supervision of nurses, all subjects took the additive at regular times daily. At the end of the 6-month additive trial, all subjects underwent a second MR and EEG data acquisition, as well as measurements of working memory capacity and cognition.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weimin Li, Dr.; Phone Number: 0086-85323549; Email: liweimin1@xjtu.edu.cn
• Study Contact Backup: Name: Xia Liao, Dr.; Phone Number: 0086-85323549; Email: fraya0213@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710086
      • Fengdong New City Service Center for the Elderly
      • Contact: Weimin Li, Dr.; Phone Number: 0086-029-85323549; Email: liweimin1@xjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Age 60 to 70, gender is not limited.

Exclusion Criteria:

• Delirium, confusion, confusion of consciousness.
• Alzheimer's disease, Parkinson's disease, stroke, cerebral hemorrhage, brain tumor, hydrocephalus.
• Viral, fungal, and syphilis infections.
• Sufferers from cerebrovascular disease (as demonstrated by a Hachinski ischemic score, or neuroimaging test).
• Repeated mild head trauma, or head trauma resulting in loss of consciousness (more than 1h).
• Depression, mania, and other mental disorders.
• Alcoholism and drug dependence.
• The following diseases may lead to mental retardation:

Kidney disease, respiratory system disease, heart disease, liver disease, uncontrolled diabetes, endocrine, metabolic, blood disease, malignant disease, more than 2 years have not been relieved.

• Taken any medication that may cause psychosis or affect intelligence in the past 1 month.
• known allergy to phosphatidylserine or related ingredients.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phosphatidylserine group; subjects in the treatment group oral the PS (600mg/d, q.d.) for 6 months.	Dietary supplement: Phosphatidylserine; subjects in the treatment group oral the PS (600mg/d, q.d.) for 6 months.
Placebo Comparator: Bean powder group; Subjects in the control group were given a placebo, which was the same shape of bean powder(600mg/d, q.d.) for 6 months.	Dietary supplement: Bean powder; Subjects in the control group were given a placebo, which was the same shape of bean powder(600mg/d, q.d.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of functional connectivity, points .	the strength of functional connectivity, from 0 to 1	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of point in Montreal Cognitive Assessment (MoCA) test	MOCA scale from 0 to 30, higher score means higher cognitive ability	1 Year
The change of point in Mini-mental State Examination (MMSE) test, points.	MMSE scale from 0 to 30, higher score means higher cognitive ability	1 Year
The change of working memory test, points.	The computer program to test memory ability, scale from 0 to 100, higher score means higher memory ability	1Year.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Air Force Military Medical University, China; Fengdong New Town Elderlywelfare Service Center
• Investigators: Study Director: Weimin Li, Dr., The First Affiliated Hospital of Xi 'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Aging; Cognitive; Phosphatide
• Other Study ID Numbers: XJTU1AF2021LSY-200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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