UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of sleep curtailment on energy balance and appetite
Title of the study (Brief title)	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	Eiichi Yoshimura
Organization	Prefectural University of Kumamoto
Division name	Faculty of Environmental and Symbiotic Sciences
Address	3-1-100 Tsukide, Higashi-ku, Kumamoto
TEL	096-383-2929
Email	publichealth-kku@umin.ac.jp

Public contact
Name of contact person	Eiichi Yoshimura
Organization	Prefectural University of Kumamoto
Division name	Faculty of Environmental and Symbiotic Sciences
Address	3-1-100 Tsukide, Higashi-ku, Kumamoto
TEL	096-383-2929
Homepage URL
Email	publichealth-kku@umin.ac.jp

Sponsor
Institute	Prefectural University of Kumamoto
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 01 Day
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

Related information
URL releasing protocol	https://www.sciencedirect.com/science/article/pii/S0031938417303992?via%3Dihub
Publication of results	Published
URL releasing results	https://www.sciencedirect.com/science/article/pii/S0031938417303992?via%3Dihub
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).
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028584