UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041456 |
|---|---|
| Receipt number | R000047320 |
| Scientific Title | The effects food intake during the day on sleep |
| Date of disclosure of the study information | 2020/08/19 |
| Last modified on | 2021/02/24 09:17:44 |
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Basic information
Public title
The effects food intake during the day on sleep
Acronym
The effects food intake during the day on sleep
Scientific Title
The effects food intake during the day on sleep
Scientific Title:Acronym
The effects food intake during the day on sleep
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of food ingestion during the day on sleep
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep self-assessment
Key secondary outcomes
Sleep Quality Instrument Measurement
Mood State Self-Assessment
Pre-survey
Pre-sleep survey
Post-survey
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test food
Interventions/Control_2
Control food
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy person from 20 to 70 years of age
(2)A person who are anxious about sleep
(3)A person who eats three meals a day ,regularly
(4)A person who sleep more than 5 hours a day
(5)A person who are able to go to bed
and get up on time and live as usual during the test period
(6)A person who can sleep in the same place for the during the test period
(7)A person who refrain from exercise during the test period
(8)A person who refrain from exercise during the test period
(9)A person who refrain from consuming caffeine after dinner during the test period
(10)A person who can come to the site
on the first and last day of the test
(11)A person who have eaten test food and control food and have no problems with intake
Key exclusion criteria
(1)Pregnat,lactating or menstruating women during the test period
(2)A person in an environment that may affect sleep
(3)A person who take sleep-related treatments,medications or supplements
(4)A person who have food allergies
(5)A person who have allergies to metal,rubber,etc
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Jinguu |
Organization
Kanazawa Institute of Technology
Division name
Department of Information Frontier Studies,Psychological Sciences Section
Zip code
924-0838
Address
3-1, Yatsukaho, Hakusan-shi, Ishikawa
TEL
076-274-7296
jinguh@neptune.kanazawa-it.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Osawa |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
Homepage URL
Oosawa_Kenji@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
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
Shiba Palace Clinic
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1590
jimukyoku@mail.souken-r.com
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
| 2020 | Year | 08 | Month | 19 | 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
62
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
| 2020 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2021 | Year | 02 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 18 | Day |
Last modified on
| 2021 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047320
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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