UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027505 |
|---|---|
| Receipt number | R000031527 |
| Scientific Title | Effect of L-serin ingestion on circadian photoentrainment -a randomized, double-blind, and placebo-controlled study- |
| Date of disclosure of the study information | 2017/05/26 |
| Last modified on | 2017/05/26 19:09:06 |
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Basic information
Public title
Effect of L-serin ingestion on circadian photoentrainment -a randomized, double-blind, and placebo-controlled study-
Acronym
Effect of L-serin ingestion on circadian photoentrainment
Scientific Title
Effect of L-serin ingestion on circadian photoentrainment -a randomized, double-blind, and placebo-controlled study-
Scientific Title:Acronym
Effect of L-serin ingestion on circadian photoentrainment
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effects of ingestion of L-serin on circadian photoentrainment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dim Light Melatonin Onset (DLMO)
Key secondary outcomes
Psychomotor Vigilance Task (PVT)
Karolinska. Sleepiness Scale (KSS)
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
Single ingestion of L-serin 30 minutes before bed time
Interventions/Control_2
Single ingestion of placebo 30 minutes before bed time
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
Male univercity students or graduate students
Key exclusion criteria
1)Subjects who take hyponotics and sedatives
2)Subjects who are shift worker or night worker
3)Subjects whose DLMO was not detected by screening test
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigekazu Higuchi |
Organization
Kyushu University
Division name
Department of Human Science
Zip code
Address
4-9-1, Shiobaru, Minami-ku, Fukuoka
TEL
092-553-4523
higu-s@design.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sang-il Lee |
Organization
Kyushu University
Division name
Department of Human Science
Zip code
Address
4-9-1, Shiobaru, Minami-ku, Fukuoka
TEL
092-553-4523
Homepage URL
sangil98@gmail.com
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
九州大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 26 | 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
| 2014 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | 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 | 05 | Month | 26 | Day |
Last modified on
| 2017 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031527
