UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036999 |
|---|---|
| Receipt number | R000042155 |
| Scientific Title | Improvement of cognitive function by ingestion of Phosphatidylserine containing supplement |
| Date of disclosure of the study information | 2020/06/05 |
| Last modified on | 2019/06/07 18:52:48 |
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Basic information
Public title
Improvement of cognitive function by ingestion of Phosphatidylserine containing supplement
Acronym
Improvement of cognitive function by Phosphatidylserine
Scientific Title
Improvement of cognitive function by ingestion of Phosphatidylserine containing supplement
Scientific Title:Acronym
Improvement of cognitive function by Phosphatidylserine
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To inspect the improvement effect of the cognitive function by taking of Phosphatidylserine containing supplement for 6 weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate cognitive function using Mini Mental State Examination (MMSE)
Key secondary outcomes
Standard verbal paired-associate learning test, Benton visual retention test
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take 3 tablets of Phosphatidylserine-containing supplement daily for 6 weeks
Interventions/Control_2
Take 3 placebo tablets daily for 6 weeks
Interventions/Control_3
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)persons who is 60 years old or older
(2)persons who is generally judged as healthy
(3)persons who can give voluntary written consent to participate in the present trial
Key exclusion criteria
(1)persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study
(2)persons who have changed their habitats to take supplements within past 4 weeks.
(3)persons who work in night shift or in day and night shift
(4)persons who have been treated their illness or prevention in a clinic at their informed consent
(5)persons with their medical histories as follows: serious diseases of sugar metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system
(6)persons with the medical histories of alcoholism or drug dependence
(7)persons who might be developed allergic reaction to foods.
(8)persons who are pregnant, breast-feeding, or hope to be pregnant during the study period
(9)persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device)
(10)persons who will not be judged suitable to the participants by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Ohnuki |
Organization
Faculty of Humanity-Oriented Science and Engineering, Kindai University
Division name
Food Functional Science Laboratory
Zip code
820-0011
Address
11-6,Kayanomori,Iizuka-shi, Fukuoka, Japan
TEL
0948-22-5655
ohnuki@fuk.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Ohnuki |
| Middle name | |
| Last name | Koichiro |
Organization
Faculty of Humanity-Oriented Science and Engineering, Kindai University
Division name
Food Functional Science Laboratory
Zip code
820-0011
Address
11-6,Kayanomori,Iizuka-shi, Fukuoka, Japan
TEL
0948-22-5655
Homepage URL
ohnuki@fuk.kindai.ac.jp
Sponsor or person
Institute
Faculty of Humanity-Oriented Science and Engineering, Kindai University
Institute
Department
Personal name
Funding Source
Organization
Japan Outgoing Integrated Medical Association
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kinki University Faculty of Industrial Science and Technology Ethics Committee
Address
11-6,Kayanomori,Iizuka-shi, Fukuoka, Japan
Tel
0948-22-5655
ohnuki@fuk.kindai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
一般社団法人機能性天然物研究機構（福岡県）
General Corporate Judicial Person Functional Natural Products Research Organization(Fukuoka,Japan)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 05 | 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
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
Preinitiation
Date of protocol fixation
| 2019 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 07 | Day |
Last modified on
| 2019 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042155
