AgingPICFITENCT04920305
Phosphatidylserine Improves Cognitive Function in the Elderly
A study testing Phosphatidylserine and Bean powder in people with Aging, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Phosphatidylserine and Bean powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 to 70, gender is not limited.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fengdong New City Service Center for the Elderly
Xi'an, Shaanxi, 710086
Weimin Li, Dr., 0086-029-85323549, liweimin1@xjtu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Aging
- Being tested
- Phosphatidylserine, Bean powder
- Keywords
- Aging, Phosphatide, Cognitive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhosphatidylserineDietary supplement
subjects in the treatment group oral the PS (600mg/d, q.d.) for 6 months.
Bean powderDietary supplement
Subjects in the control group were given a placebo, which was the same shape of bean powder(600mg/d, q.d.).
| Study group | Role | What they receive |
|---|---|---|
| Phosphatidylserine group | Experimental | subjects in the treatment group oral the PS (600mg/d, q.d.) for 6 months. Receives: Dietary Supplement: Phosphatidylserine |
| Bean powder group | Placebo comparator | Subjects in the control group were given a placebo, which was the same shape of bean powder(600mg/d, q.d.) for 6 months. Receives: Dietary Supplement: Bean powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of functional connectivity, points .
the strength of functional connectivity, from 0 to 1
Measured: 1 Year
Secondary outcomes (3)
The change of point in Montreal Cognitive Assessment (MoCA) test
MOCA scale from 0 to 30, higher score means higher cognitive ability
Measured: 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
Measured: 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
Measured: 1Year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Sep 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China, Fengdong New Town Elderlywelfare Service Center
- Responsible party
- Sponsor
- Investigators
- Weimin Li, Dr., Study director, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920305
- Sponsor's protocol ID
- XJTU1AF2021LSY-200
- Acronym
- PICFITE
- Status last verified
- May 2021
- First submitted
- 21 May 2021
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effect of Phosphatidylserine on Cognitive Function Improvement in the Elderly
- ClinicalTrials.gov ID
- NCT04920305
- Acronym / sponsor ID
- PICFITE / XJTU1AF2021LSY-200
- Conditions
- Aging
- Keywords
- Aging, Phosphatide, Cognitive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China, Fengdong New Town Elderlywelfare Service Center
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phosphatidylserine group | Experimental | Dietary Supplement: Phosphatidylserinesubjects in the treatment group oral the PS (600mg/d, q.d.) for 6 months. |
| Bean powder group | Placebo comparator | Dietary Supplement: Bean powderSubjects in the control group were given a placebo, which was the same shape of bean powder(600mg/d, q.d.) for 6 months. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 60 to 70, gender is not limited.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phosphatidylserinesubjects in the treatment group oral the PS (600mg/d, q.d.) for 6 months. | Dietary supplement | Phosphatidylserine group |
| Bean powderSubjects in the control group were given a placebo, which was the same shape of bean powder(600mg/d, q.d.). | Dietary supplement | Bean powder group |
Primary outcome
The change of functional connectivity, points .
Time frame: 1 Year
the strength of functional connectivity, from 0 to 1
3 secondary outcomes
The change of point in Montreal Cognitive Assessment (MoCA) test
Time frame: 1 Year
The change of point in Mini-mental State Examination (MMSE) test, points.
Time frame: 1 Year
The change of working memory test, points.
Time frame: 1Year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No
Related trials for Aging
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Active, not recruiting
Iterative Design Trial to Assess Dietary Supplements and Other Aging-targeted Therapies
Aging, Longevity
Not yet recruitingObservational study
Biological Aging Following Full-Arch Implant-Supported Fixed Rehabilitation in Edentulous Patients
Edentulism, Biological Aging
Recruiting
Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation
Skin Aging
Not yet recruitingPhase 2
Effects of Switch to Doravirine/Islatravir vs. Continued Antiretroviral Therapy on Biomarkers of Aging Among Virologically Suppressed People With HIV
Epigenetic Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weimin Li, Dr. study director
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phosphatidylserine and Bean powder in people with Aging, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weimin Li, Dr. (0086-85323549, liweimin1@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of functional connectivity, points . (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022; AzTrials last refreshed its copy on 28 Oct 2026.