UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037162 |
|---|---|
| Receipt number | R000042345 |
| Scientific Title | The effect of sleep curtailment and sleep timing on appetite and food preference |
| Date of disclosure of the study information | 2019/06/25 |
| Last modified on | 2020/09/09 18:19:20 |
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Basic information
Public title
The effect of sleep curtailment and sleep timing on appetite and food preference
Acronym
The effect of sleep curtailment and sleep timing on appetite and food preference
Scientific Title
The effect of sleep curtailment and sleep timing on appetite and food preference
Scientific Title:Acronym
The effect of sleep curtailment and sleep timing on appetite and food preference
Region
| Japan |
Condition
Condition
Healthy lean adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify whether sleep curtailment affect on energy intake, appetite, food preference.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
energy intake
Key secondary outcomes
food preference, appetite regulating hormone, subjective sleep drive, subjective appetite, eye tracking, blood hormone
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
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Continuous 4 nights sleep curtailment (5h,26:00-7:00).
Washout period is 3 weeks. Women present for the study within 14 days after the menstrual period.
Interventions/Control_2
Continuous 4 nights sleep (8h,23:00-7:00).
Washout period is 3 weeks. Women present for the study within 14 days after the menstrual period.
Interventions/Control_3
Continuous 4 nights sleep curtailment (5h,23:00-4:00).
Washout period is 3 weeks. Women present for the study within 14 days after the menstrual period.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Aged >20 years
BMI <25 kg/m2
Key exclusion criteria
Metabolic disorders
Sleep disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Yoshimura |
Organization
Prefectural University of Kumamoto
Division name
Faculty of Environmental and Symbiotic Sciences
Zip code
8628502
Address
3-1-100 Tsukide, Higashi-ku, Kumamoto
TEL
096-383-2929
publichealth-kku@umin.ac.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Yoshimura |
Organization
Prefectural University of Kumamoto
Division name
Faculty of Environmental and Symbiotic Sciences
Zip code
8628502
Address
3-1-100 Tsukide, Higashi-ku, Kumamoto
TEL
096-383-2929
Homepage URL
publichealth-kku@umin.ac.jp
Sponsor or person
Institute
Prefectural University of Kumamoto
Institute
Department
Personal name
Funding Source
Organization
Japan Society For The Promotion Of Science
Grant-in-Aid for Scientific Research (C), Japan Society For The Promotion Of Science Grant-in-Aid for JSPS Fellows
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Prefectural University of Kumamoto
Address
3-1-100 Tsukide, Higashi-ku, Kumamoto
Tel
096-383-2929
publichealth-kku@umin.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
| 2019 | Year | 06 | Month | 25 | 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
24
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
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 06 | Month | 25 | Day |
Last modified on
| 2020 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042345
