UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051592 |
|---|---|
| Receipt number | R000058862 |
| Scientific Title | Effects of consumption of phosphatidylserine on the cognitive function: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2023/07/12 |
| Last modified on | 2024/08/29 15:49:17 |
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Basic information
Public title
Effects of consumption of phosphatidylserine on the cognitive function: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Acronym
Effects of consumption of phosphatidylserine on the cognitive function: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title
Effects of consumption of phosphatidylserine on the cognitive function: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of phosphatidylserine on the cognitive function
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main objective of this trial is to verify the effects of consumption of the test food for 12 weeks on the cognitive function in healthy Japanese subjects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of the standardized score of composite memory at 12 weeks after consumption (12w)
Key secondary outcomes
1. The amount of change of the standardized score of composite memory between screening (before consumption; Scr) and 12w
2. The measured value of the standardized scores of each cognitive domain {neurocognition index (NCI), verbal memory, visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, social acuity, reasoning, working memory, sustained attention, simple attention and motor speed} at 12w and the amount of change of each item from Scr to 12w
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: DHAPS(R) product
Administration: Take 4 capsules per day after breakfast with warm water.
*Daily dose should be taken within the day. If a dose is missed, take it as soon as you remember within that day. Avoid carrying over a dose to the following day.
Interventions/Control_2
Duration: 12 weeks
Test food: BioPS(R) product
Administration: Take 4 capsules per day after breakfast with warm water.
*Daily dose should be taken within the day. If a dose is missed, take it as soon as you remember within that day. Avoid carrying over a dose to the following day.
Interventions/Control_3
Duration: 12 weeks
Test food: Microcrystalline Cellulose (Placebo)
Administration: Take 4 capsules per day after breakfast with warm water.
*Daily dose should be taken within the day. If a dose is missed, take it as soon as you remember within that day. Avoid carrying over a dose to the following day.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Male and female
3. Subjects aged 35-65
4. Healthy subjects
5. Subjects who notice a decline in memory
6. Subjects whose scoring of Mini Mental State Examination (MMSE) is 24 or more
7. Subjects who met the inclusion criteria 1~6 and have relatively low standardized score in composite memory measured using Cognitrax at Scr (Selection of those with relatively low standardized scores will be conducted in blocks of "Subjects aged 50 or over" and "Subjects aged under 50")
8. Subjects who are judged as eligible to participate in the study by the physician
Key exclusion criteria
1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction
2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who have dementia
5. Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues
6. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage, as part of their daily intake
7. Subjects who take supplements or foods that may improve cognitive functions, such as phosphatidylserine, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), and plasmalogen, as part of their daily intake
8. Subjects who take blue-backed fish such as sardines, mackerel, and saury for 4 days/week or over
9. Subjects who use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) as part of their daily life
10. Subjects regularly taking medications (including herbal medicines) and supplements
11. Subjects who are allergic to medications and/or the test food related products
12. Subjects who are pregnant, breast-feeding or planning for pregnancy during the trial period
13. Subjects who have been enrolled in other clinical trials 28 days before the agreement to participate in this trial or those who plan to enroll in another clinical trial during the trial period
14. Subjects who are deemed ineligible to participate by the principal investigator
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
ECA Healthcare Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT05962008
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
114
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2033 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058862
