UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017160 |
|---|---|
| Receipt number | R000019906 |
| Scientific Title | Effects of nocturnal energy intake on the night time sleep |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2018/04/19 11:42:48 |
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Basic information
Public title
Effects of nocturnal energy intake on the night time sleep
Acronym
Nocturnal energy intake and night time sleep
Scientific Title
Effects of nocturnal energy intake on the night time sleep
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yuki Tada |
Organization
Tokyo University of Agriculture
Division name
Department of Nutritional Science, Faculty of Applied Bioscience
Zip code
Address
Sakuragaoka 1-1-1, Setagaya, Tokyo
TEL
03-5477-2670
y3tada@nodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Tada |
Organization
Tokyo University of Agriculture
Division name
Department of Nutritional Science, Faculty of Applied Bioscience
Zip code
Address
Sakuragaoka 1-1-1, Setagaya, Tokyo
TEL
03-5477-2670
Homepage URL
y3tada@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 17 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019906
