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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024435
Receipt No. R000028124
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 2016/10/17
Last modified on 2017/01/17

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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 repeated ingestion of L-serin on circadian rhythm, sleep habits, and daytime alertness
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 Parallel
Randomization Non-randomized
Randomization unit
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 Ingestion of L-serin for two weeks
Interventions/Control_2 Ingestion of placebo for two 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
18 years-old <=
Age-upper limit
30 years-old >
Gender Male and Female
Key inclusion criteria Male or female univercity students or graduate students who have late sleep habits
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 30

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
Email 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
Email sangil98@gmail.com

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor FANCL Corporation
Name of secondary funder(s) FANCL Corporation

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 九州大学

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 17 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 No longer recruiting
Date of protocol fixation
2016 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 17 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 10 Month 17 Day
Last modified on
2017 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028124

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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