UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036152 |
|---|---|
| Receipt number | R000040924 |
| Scientific Title | Evaluation of sleep improvement by intake of milk-derived foods |
| Date of disclosure of the study information | 2020/03/07 |
| Last modified on | 2019/06/17 08:13:56 |
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Basic information
Public title
Evaluation of sleep improvement by intake of milk-derived foods
Acronym
Evaluation of sleep improvement
Scientific Title
Evaluation of sleep improvement by intake of milk-derived foods
Scientific Title:Acronym
Evaluation of sleep improvement
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to evaluate sleep improvement by intake of milk-derived foods, a double blind crossover comparison test was conducted to evaluate Epworth Sleepiness Scale, saliva test, deliver test article, saliva collection (at home), watch pad (sleep survey).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Epworth Sleepiness Scale
Key secondary outcomes
Blood/Saliva test
Watch pad (sleep survey)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test Food
night
1 hour before bedtime
10 capsules/once
Take it with water once a day, 1h before bedtime.
Interventions/Control_2
Pracebo food
night
1 hour before bedtime
10 capsules/once
Take it with water once a day, 1h before bedtime.
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese men and women aged 20 to 59 years old at the time of acquiring consent
2) Persons who have no drunk habit
3) Persons who are living a regular life (nearly constant sleeping time)
4) Healthy person
5) Persons who are not satisfied with sleeping (bad sleeping, nocturnal awakening, waking up is bad, etc.)
6) Persons who are aware of chronic fatigue
Key exclusion criteria
1) Persons with mental disorders such as depression or those suspected of them
2) Persons who have experience in alcoholism, drug addiction or abuse
3) Persons who are taking or applying medicine (sleeping pill etc.) that seems likely to affect the examination result
4) Persons who regularly use antihistamines (for rhinitis, allergies etc.) currently, or those planning to use during the test period
5) Persons currently participating in other clinical trials
6) Persons who are in a profession with night work
7) Persons who are planning to travel domestically or overseas during the test period
8) Persons who can not consent to abstinence on the brain wave measurement day during the examination period
9) Persons who may have an allergy such as having a history of hypersensitivity to the test article
10) Persons with irregular life rhythms
11) During pregnancy or possibly pregnant, or those who are breastfeeding
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
1050013
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
03-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Kou |
| Middle name | |
| Last name | Masuda |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
1050013
Address
3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
03-5408-1555
Homepage URL
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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 | 03 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 11 | Day |
Last modified on
| 2019 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040924
| 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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| Registered date | File name |
