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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028603
Receipt No. R000032739
Scientific Title Effect of L-theanine on depressive symptoms and cognitive functions
Date of disclosure of the study information 2017/08/09
Last modified on 2019/10/04

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Basic information
Public title Effect of L-theanine on depressive symptoms and cognitive functions
Acronym Effect of L-theanine on depressive symptoms and cognitive functions
Scientific Title Effect of L-theanine on depressive symptoms and cognitive functions
Scientific Title:Acronym Effect of L-theanine on depressive symptoms and cognitive functions
Region
Japan

Condition
Condition healthy person
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to evaluate effects of L-theanine administration on depressive symptoms and cognitive functions in healthy people.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in depressive symptoms before administration, after 4 weeks, 6 weeks, and 10 weeks after administration
Key secondary outcomes Change in cognitive functions before administration, after 4 weeks, 6 weeks, and 10 weeks after administration

Base
Study type Interventional

Study design
Basic design Cross-over
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 Taking L-theanine 200mg/day once a day for 4 weeks
Interventions/Control_2 Taking placebo once a day for 4 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
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria People who have not been diagnosed with psychiatric disorders
Key exclusion criteria First, people who have been diagnosed with psychiatric disorders. Second, people during pregnancy or so suspected. Third, people who suffer from any serious physical disorders.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Kunugi
Organization National Center of Neurology and Psychiatry
Division name Department of Mental Disorder Research, National Institute of Neuroscience
Zip code
Address 4-1-1, Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL 042-341-2712
Email hkunugi@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinsuke Hidese
Organization National Center of Neurology and Psychiatry
Division name Department of Mental Disorder Research, National Institute of Neuroscience
Zip code
Address 4-1-1, Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL 042-341-2712
Homepage URL http://www.ncnp.go.jp/nin/guide/r3/index_e.html
Email shidese@ncnp.go.jp

Sponsor
Institute Department of Mental Disorder Research, National Institute of Neuroscience, National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization An Intramural Research Grants for Neurological and Psychiatric Disorders of National Center of Neurology and Psychiatry and an unrestricted research grant provided by the Taiyo Kagaku Co. Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Research and Development, Nutrition Division, Taiyo Kagaku Co. Ltd, Mie, Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 08 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 30
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
2017 Year 03 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 09 Day
Last modified on
2019 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032739

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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