UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024839 |
|---|---|
| Receipt number | R000028584 |
| Scientific Title | The effect of sleep curtailment on energy balance and appetite |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2018/01/31 18:09:55 |
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Basic information
Public title
The effect of sleep curtailment on energy balance and appetite
Acronym
The effect of sleep curtailment on energy balance and appetite
Scientific Title
The effect of sleep curtailment on energy balance and appetite
Scientific Title:Acronym
The effect of sleep curtailment on energy balance and appetite
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 physical activity, energy intake, and subjective and objective appetite.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Energy balance (physical activity and energy intake)
Key secondary outcomes
Blood hormone, subjective appetite, subjective sleep drive, and calculation task
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
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
continuous 3 nights sleep curtailment (4h)
Washout period is 1 month. Women present for the study within 14 days after the menstrual period.
Interventions/Control_2
continuous 3 nights normal sleep time (7h)
Washout period is 1 month. Women present for the study within 14 days after the menstrual period.
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
| 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 | |
| Middle name | |
| Last name | Eiichi Yoshimura |
Organization
Prefectural University of Kumamoto
Division name
Faculty of Environmental and Symbiotic Sciences
Zip code
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 | |
| Middle name | |
| Last name | Eiichi Yoshimura |
Organization
Prefectural University of Kumamoto
Division name
Faculty of Environmental and Symbiotic Sciences
Zip code
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
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
熊本県立大学
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0031938417303992?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0031938417303992?via%3Dihub
Number of participants that the trial has enrolled
Results
Sedentary time and sedentary to light-intensity activity time were significantly increased in short sleep condition (SS) compared with control sleep condition (CS). However, these significant effects were clearly attenuated after adjustment for awake time (p>0.05). Total energy intake was not significantly different between conditions. Insulin and cortisol levels after SS were significantly higher than after CS (p<0.05).
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
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 15 | Day |
Last modified on
| 2018 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028584
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
