UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055921 |
|---|---|
| Receipt number | R000063904 |
| Scientific Title | Investigation of the effect of different dinner timings on nocturnal sleep architecture and sleep quality: A randomized crossover trial |
| Date of disclosure of the study information | 2024/10/23 |
| Last modified on | 2025/04/24 09:01:26 |
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Basic information
Public title
The effect of different dinner timings on nocturnal sleep
Acronym
Different dinner timings and nocturnal sleep
Scientific Title
Investigation of the effect of different dinner timings on nocturnal sleep architecture and sleep quality: A randomized crossover trial
Scientific Title:Acronym
Different dinner timings: Effects on nocturnal sleep architecture and quality
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our study aims to examine the effect of different dinner timings on nocturnal sleep quality by setting three dinner times: 16:00, 19:00, and 22:00.
Basic objectives2
Others
Basic objectives -Others
Sleep
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep-related index (sleep stage appearance probability, sleep efficiency, sleep onset latency, Awakenings (>5 min), Wake after sleep onset, sleep stage transitions
Key secondary outcomes
Glycemic variability, cardiac nervous activity (%HF, LF/HF), core body temperature, subjective assessments using visual analogue scales
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
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Setting the dinner time to 19:00 on the day of the nocturnal sleep measurement.
Interventions/Control_2
Setting the dinner time to 16:00 on the day of the nocturnal sleep measurement.
Interventions/Control_3
Setting the dinner time to 22:00 on the day of the nocturnal sleep measurement.
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
| 29 | years-old | >= |
Gender
Male
Key inclusion criteria
Male individuals aged 18 to 29
Key exclusion criteria
1.Individuals with a extreme morning or evening chronotype
2.Individuals with a smoking habit
3.Individuals with diseases, sleep disorders, or mental disorders that impair their capacity for self-care, or those under medical prescription
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Yoshizaki |
Organization
Toyo University
Division name
Faculty of Health and Sports Sciences
Zip code
115-8650
Address
1-7-11 Akabanedai, Kita-city, Tokyo
TEL
03-5924-2823
yoshizaki@toyo.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Yoshizaki |
Organization
Toyo University
Division name
Faculty of Health and Sports Sciences
Zip code
115-8650
Address
1-7-11 Akabanedai, Kita-city, Tokyo
TEL
03-5924-2823
Homepage URL
yoshizaki@toyo.jp
Sponsor or person
Institute
Toyo University
Institute
Department
Personal name
Funding Source
Organization
Toyo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Concerning Medical Research Involving Human Subjects
Address
2100 Kujirai, Kawagoe-shi, Saitama, Japan 350-8585
Tel
049-239-1440
hoshi@toyo.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
| 2024 | Year | 10 | Month | 23 | 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
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 23 | Day |
Last modified on
| 2025 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063904
