UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of nocturnal energy intake on the night time sleep
Title of the study (Brief title)	Nocturnal energy intake and night time sleep
Region	Japan

Condition
Condition	Healthy female
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to determine the effects of the nocturnal energy intake on the night time sleep among female.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Autonomic nervous system at sleeping period after taking the test meal.
Key secondary outcomes	Sleep latency, sleep efficiency, No. of awakenings after taking the test meal.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	High nocturnal intake
Interventions/Control_2	Low nocturnal intake
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	Not applicable
Gender	Female
Key inclusion criteria	Healthy volunteer
Key exclusion criteria	Who has strenuous exercise habit, pregnancy or lactation, taking any medications affecting on sleep, smoking habits or drinking habits
Target sample size	30

Research contact person
Name of lead principal investigator	Yuki Tada
Organization	Tokyo University of Agriculture
Division name	Department of Nutritional Science, Faculty of Applied Bioscience
Address	Sakuragaoka 1-1-1, Setagaya, Tokyo
TEL	03-5477-2670
Email	y3tada@nodai.ac.jp

Public contact
Name of contact person	Yuki Tada
Organization	Tokyo University of Agriculture
Division name	Department of Nutritional Science, Faculty of Applied Bioscience
Address	Sakuragaoka 1-1-1, Setagaya, Tokyo
TEL	03-5477-2670
Homepage URL
Email	y3tada@nodai.ac.jp

Sponsor
Institute	Tokyo University of Agriculture
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization	Government offices of other countries
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

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 17 Day
Anticipated trial start date	2015 Year 06 Month 05 Day
Last follow-up date	2016 Year 07 Month 25 Day
Date of closure to data entry	2016 Year 12 Month 30 Day
Date trial data considered complete	2017 Year 07 Month 30 Day
Date analysis concluded	2017 Year 12 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 17 Day
Last modified on	2018 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019906