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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024035
Receipt No. R000025952
Scientific Title Does tryptophan-containing supplement improve depressive mood and autonomic nervous system function?
Date of disclosure of the study information 2016/10/01
Last modified on 2017/03/14

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Basic information
Public title Does tryptophan-containing supplement improve depressive mood and autonomic nervous system function?
Acronym Does tryptophan-containing supplement improve depressive mood and autonomic nervous system function?
Scientific Title Does tryptophan-containing supplement improve depressive mood and autonomic nervous system function?
Scientific Title:Acronym Does tryptophan-containing supplement improve depressive mood and autonomic nervous system function?
Region
Japan

Condition
Condition depressive mood
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify whether tryptophan-containing supplement can improve depressive mood and autonomic nervous system function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes depressive mood
- pre and post 1 week-intervention
Key secondary outcomes autonomic nerve activity
body composition
blood biochemical parameters
- pre and post 1 week-intervention

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 Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 1-week oral ingestion of test supplement
Interventions/Control_2 1-week oral ingestion of placebo supplement
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
18 years-old <=
Age-upper limit
29 years-old >=
Gender Male and Female
Key inclusion criteria healthy university students and graduate students
Key exclusion criteria 1. individuals who have mental disorders
2. individuals during pregnancy or breast-feeding
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Hayashi
Organization Kyoto University
Division name Graduate School of Human and Environmental Studies
Zip code
Address Yoshidanihonmatsu-cho, Sakyo-ku, Kyoto, Japan
TEL 075-753-6640
Email tatsuya@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Natsuki Tsujita
Organization Kyoto University
Division name Graduate School of Human and Environmental Studies
Zip code
Address Yoshidanihonmatsu-cho, Sakyo-ku, Kyoto, Japan
TEL 075-753-6640
Homepage URL
Email natsuki.morita823@gmail.com

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Program(SIP),(funding agency: Bio-oriented Technology Research Advancement Institution, NARO)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2016 Year 10 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
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
2016 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2017 Year 03 Month 14 Day
Date of closure to data entry
2017 Year 03 Month 14 Day
Date trial data considered complete
2017 Year 03 Month 14 Day
Date analysis concluded
2017 Year 03 Month 14 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 13 Day
Last modified on
2017 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025952

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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