UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046025 |
|---|---|
| Receipt number | R000052480 |
| Scientific Title | Evaluation of effects of food intake or meditation on sleep state |
| Date of disclosure of the study information | 2021/11/12 |
| Last modified on | 2023/11/13 07:05:31 |
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Basic information
Public title
Evaluation of effects of food intake or meditation on sleep state
Acronym
Evaluation of effects of food intake or meditation on sleep state
Scientific Title
Evaluation of effects of food intake or meditation on sleep state
Scientific Title:Acronym
Evaluation of effects of food intake or meditation on sleep state
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of food intake or meditation on sleep state
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OSA sleep inventory MA version
at 0-1week on term 1-6 and untreated term
Key secondary outcomes
Sleep monitoring
Diary
Questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
7
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Perform meditation for 1 week
Interventions/Control_2
Intake test food 1 for 1 week
Interventions/Control_3
Intake test food 2 for 1 week
Interventions/Control_4
Intake test food 3 for 1 week
Interventions/Control_5
Intake test food 4 for 1 week
Interventions/Control_6
Intake placebo for 1 week
Interventions/Control_7
No treatment
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged 30 to 59 years old
2) Subjects who lead a regular life (sleep almost constantly)
3) Subjects who work full-time on weekdays (Monday through Friday) and have weekends and holidays off
4) Healthy adults who are not visiting hospitals or taking medication for the treatment of illness
5) Subjects who are dissatisfied with their sleep (difficulty falling asleep, waking up in the middle of sleep, difficulty waking up, etc.)
6) Subjects who are aware of chronic fatigue
7) Subjects who can consent not to drink alcohol though the test period
8) Subjects who sleep alone in bed
9) Subjects who use beds with mattress whose thickness is within the range of 5 cm or more and 50 cm or less
10) Subjects who can put a device (175 mm x 175 mm, 13 mm thin) under the mattress to measure sleep conditions
11) Subjects who use smartphones with iOS 12.0.0 or higher, Android 6.0 or higher
12) Subjects who can consent to install an application to their smartphones to monitor their sleep conditions
13) Subjects who sleep an average of 5 hours or more
14) Subjects who can consent to consume around 1GB of data to upload to the application to monitor their sleep conditions
Key exclusion criteria
1) Subjects who are undergoing treatment for insomnia or sleep disorders
2) Subjects who are said to snore frequently during the night, and those who are often awakened by snoring
3) Smokers
4) Subjects who have a habit of drinking at least once a week
5) Subjects with or suspected of having a mental illness such as depression
6) Subjects with a history of alcoholism, drug dependence, or abuse
7) Subjects who regularly use medicines or health foods (related to sleep, stress, and fatigue) that may affect the test results.
8) Subjects who are currently using antihistamines regularly or who plan to use them during the study period
9) Subjects who plan to be transferred or change jobs during the test period
8) Shift workers or midnight shift workers
8) Subjects who plan to travel abroad during the test period
10) Subjects who plan to travel domestically or go on domestic business trips with overnight stays during one or more of the following periods: the pre-observation period, the test food intake period, and the meditation period
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Kaneko |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1555
Homepage URL
m_kaneko@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
EZAKI GLICO CO.,LTD.
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2021 | Year | 11 | Month | 12 | 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
120
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
| 2021 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 10 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052480
