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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024121
Receipt No. R000027771
Scientific Title The effect of tryptophan-supplement intake at breakfast on melatonin secretion at night
Date of disclosure of the study information 2016/09/21
Last modified on 2017/03/24

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Basic information
Public title The effect of tryptophan-supplement intake at breakfast on melatonin secretion at night
Acronym The effect of tryptophan-supplement intake at breakfast on melatonin secretion at night
Scientific Title The effect of tryptophan-supplement intake at breakfast on melatonin secretion at night
Scientific Title:Acronym The effect of tryptophan-supplement intake at breakfast on melatonin secretion at night
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to reveal if Tryptophan-supplement intake at breakfast can increase melatonin secretion at night.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Nocturnal melatonin secretion which is measured immediately after intervention
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food
Interventions/Control_1 Tryptophan-supplement intake at breakfast and bright light exposure during daytime (only 1day)
Interventions/Control_2 Placebo-supplement intake at breakfast and bright light exposure during daytime (only 1day)
Interventions/Control_3 Tryptophan-supplement intake at breakfast and dim light exposure during daytime (only 1day)
Interventions/Control_4 Placebo-supplement intake at breakfast and dim light exposure during daytime (only 1day)
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

Not applicable
Gender Male
Key inclusion criteria Healthy adult male
Key exclusion criteria 1. Mental diseases
2. Extreame morningness-type
3. Extreame eveningness-type
4. Sleep disorder
5. Smorker
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Morita
Organization Fukuoka Women's University
Division name Graduate School of Health and Environmental Science
Zip code
Address 1-1-1, Kasumigaoka, Higashi-ku, Fukuoka-city, Fukuoka
TEL 092-673-0293
Email morita@fwu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Morita
Organization Fukuoka Women's University
Division name Graduate School of Health and Environmental Science
Zip code
Address 1-1-1, Kasumigaoka, Higashi-ku, Fukuoka-city, Fukuoka
TEL 092-673-0293
Homepage URL
Email morita@fwu.ac.jp

Sponsor
Institute Fukuoka Women's University
Institute
Department

Funding Source
Organization MEXT(Japan)
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 09 Month 21 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
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
2014 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 08 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
2016 Year 09 Month 21 Day
Last modified on
2017 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027771

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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