UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063238 |
|---|---|
| Receipt number | R000072380 |
| Scientific Title | Effects of meal timing in timerestricted eating on sleep and cognitive-motor function |
| Date of disclosure of the study information | 2026/10/13 |
| Last modified on | 2026/10/10 20:51:22 |
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Basic information
Public title
A study on the effects of time-restricted eating on sleep and daytime concentration
Acronym
The effects of time-restricted eating on sleep and concentration
Scientific Title
Effects of meal timing in timerestricted eating on sleep and cognitive-motor function
Scientific Title:Acronym
Time-restricted eating, sleep, and cognitive-motor function
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to compare the effects of morning time-restricted eating (meals between 8:00 and 16:00) and evening time-restricted eating (meals between 12:00 and 20:00) on sleep and cognitive-motor function (vigilance and grip strength) in healthy adults using a crossover design.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective sleep assessment (3DSS, VAS)
Objective sleep assessment (accelerometer)
Key secondary outcomes
Cognitive function (PVT)
Grip strength
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Morning TRE (eating between 8:00 and 16:00, 14 days)
Interventions/Control_2
Evening TRE (eating between 12:00 and 20:00, 14 days)
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
| 39 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy men and women aged 18 to 39 years at the time of obtaining consent 2) Those who have received sufficient explanation about participation in the study, fully understand it, and have provided written consent of their own free will
Key exclusion criteria
1) Individuals who are currently receiving regular outpatient treatment or medication for sleep disorders, mental disorders, etc. 2) Individuals who plan overseas travel involving a time difference of 3 hours or more, or long-distance travel, during the study period 3) Individuals with a history of eating disorders or who are currently restricting their diet 4) Individuals currently under treatment for serious physical illness or injury 5) Others judged by the principal investigator to be inappropriate for participation in this study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Nishida |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192 JAPAN
TEL
0429476771
nishida@waseda.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Nishida |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
3591192
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192 JAPAN
TEL
0429476771
Homepage URL
nishida@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda 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
Waseda University Ethics Review Committee for Research Involving Human Subjects
Address
Room 101, Building 121, Waseda University, 513 Waseda Tsurumaki-cho, Shinjuku-ku, Tokyo 162-0041
Tel
03-5272-1639
rinri@list.waseda.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
| 2026 | Year | 10 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 10 | Month | 10 | Day |
Last modified on
| 2026 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072380
