UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036364 |
|---|---|
| Receipt number | R000039339 |
| Scientific Title | Double-blind randomized controlled trial investigating the neurocognitive effects of pig liver-derived phosphatidylcholine in healthy adult volunteer. |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/09/29 13:39:11 |
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Basic information
Public title
Double-blind randomized controlled trial investigating the neurocognitive effects of pig liver-derived phosphatidylcholine in healthy adult volunteer.
Acronym
The neurocognitive effects of pig liver-derived phosphatidylcholine
Scientific Title
Double-blind randomized controlled trial investigating the neurocognitive effects of pig liver-derived phosphatidylcholine in healthy adult volunteer.
Scientific Title:Acronym
The neurocognitive effects of pig liver-derived phosphatidylcholine
Region
| Japan | Asia(except Japan) |
Condition
Condition
healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The neurocognitive effects of pig liver-derived phosphatidylcholine
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function was evaluated at the pre-dose point and after 4 weeks of active treatment by means of WMS-R
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
active (phosphatidylcholine)
Interventions/Control_2
placebo
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy adult volunteer.
Key exclusion criteria
1. pregnancy
2. do not undergo neurophysiological test
3. dietary of having memory effect
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tatsuro |
| Middle name | |
| Last name | Mori |
Organization
Mori neurosurgical clinic
Division name
clinic
Zip code
142-0053
Address
Nakanobe 5-2-2, Shinagawa-ku, Tokyo, Japan
TEL
03-3788-1777
research@mhrri.com
Public contact
Name of contact person
| 1st name | Tatsuro |
| Middle name | |
| Last name | Mori |
Organization
Mori neurosurgical clinic
Division name
clinic
Zip code
142-0053
Address
Nakanobe 5-2-2, Shinagawa-ku, Tokyo, Japan
TEL
03-3788-1777
Homepage URL
research@mhrri.com
Sponsor or person
Institute
Sugarlady Cosmetics Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Sugarlady Cosmetics Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical and Health Resources Research Institute
Address
4-38-7, Higashi0Ikebukuor, Toshima-ku, Tokyo 170-0013, Japan
Tel
03-5904-8534
research@mhrri.com
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 01 | 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
60
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
| 2019 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 25 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 17 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 31 | Day |
Last modified on
| 2019 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039339
