UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052597 |
|---|---|
| Receipt number | R000059667 |
| Scientific Title | Investigation of the effect of L-theanine on improving sleep habits |
| Date of disclosure of the study information | 2023/10/24 |
| Last modified on | 2024/10/23 09:33:08 |
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Basic information
Public title
Investigation of the effect of L-theanine on improving sleep habits
Acronym
Investigation of the effect of L-theanine on improving sleep habits
Scientific Title
Investigation of the effect of L-theanine on improving sleep habits
Scientific Title:Acronym
Investigation of the effect of L-theanine on improving sleep habits
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to test whether L-theanine improves social jet lag via its sleep-improving effect on study subjects who normally have sleep debt and social jet lag.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in sleeping and waking times on weekdays and weekends (social jet lag)
Key secondary outcomes
Changes in sleep quality, anxiety and stress, and body temperature rhythms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
L-theanine 200mg/day for 2weeks
Interventions/Control_2
dextrin
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Workers between the ages of 18 and 59.
2) Those who have social jet lag of 1.5 hours or more and usually feel sleep deprived (social jet lag indicates the difference in median sleep time on weekdays and weekends).
(3) Those who have weekends off and work on weekdays.
(iv) Those who are able to participate in the study during the period specified here.
(5) Those who can submit the results of medical examinations taken within the past year.
Key exclusion criteria
(1) Those who regularly use sleeping pills or sleeping supplements
2) Persons who are regularly using medications (drugs that affect metabolism, such as diabetes medications, alpha-blockers, beta-blockers, etc.)
(iii) Those who have diseases that affect metabolism (diabetes, thyroid function, liver disorder, renal disorder)
(iv) Those with a diagnosis or history of psychiatric disorders
(v) Those who use pacemakers or other implantable medical devices
(6) Persons with serious cardiovascular disease
(7) Patients with cancer
(8) Those with a history of gastrointestinal surgery (mainly pharynx, esophagus, stomach, duodenum, small intestine, colon, rectum, cecum, pancreas, and liver are applicable. However, appendicectomy is acceptable)
(ix) Those who have knee or back disease and have difficulty in performing their duties.
(10) Pregnant women, nursing mothers, and those planning to become pregnant.
(11) Those with extremely irregular eating habits.
(12)Exercisers who have an exercise habit (average of 60 minutes/day or more)
(13)Participating or intending to participate in trials involving the ingestion of other foods, the administration of drugs, or the application of cosmetics, drugs, etc.
(14)Persons who are unable to put apps on their cell phones (lifestyle recording apps are used in the study)
(15) Those who have a daily nap habit of at least 30 minutes
(16)Permanent teleworkers or those who work shift work or night shifts at least one day per week
(17)Persons who snore frequently or suffer from sleep apnea
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Tahara |
Organization
Hiroshima University
Division name
Department of Public Health and Health Policy
Zip code
734-0037
Address
Kasumi 1-2-3, Hiroshima-shi, Hiroshima
TEL
07026426103
yutahara@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Tahara |
Organization
Hiroshima University
Division name
Department of Public Health and Health Policy
Zip code
734-0037
Address
Kasumi 1-2-3, Hiroshima-shi, Hiroshima
TEL
07026426103
Homepage URL
yutahara@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
TIYO KAGAKU
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3, Hiroshima-shi, Hiroshima
Tel
082-257-1551
iryo-sinsa@office.hiroshima-u.ac.jp
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
| 2023 | Year | 10 | Month | 24 | 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
| 2023 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 10 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 24 | Day |
Last modified on
| 2024 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059667
