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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036364
Receipt No. 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

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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
Email 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
Email research@mhrri.com

Sponsor
Institute Sugarlady Cosmetics Co., Ltd
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039339

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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