UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028603 |
|---|---|
| Receipt number | 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 13:17:52 |
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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
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
shidese@ncnp.go.jp
Sponsor or person
Institute
Department of Mental Disorder Research, National Institute of Neuroscience, National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032739
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
