UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024121 |
|---|---|
| Receipt number | 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 10:11:03 |
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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
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
morita@fwu.ac.jp
Sponsor or person
Institute
Fukuoka Women's University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027771
| 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 |
