UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053447 |
|---|---|
| Receipt number | R000060878 |
| Scientific Title | A study to evaluate the effects of consumption of the test beverage on sleep quality |
| Date of disclosure of the study information | 2024/01/26 |
| Last modified on | 2024/01/12 14:58:53 |
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Basic information
Public title
A study to evaluate the effects of consumption of the test beverage on sleep quality
Acronym
A study to evaluate the effects of consumption of the test beverage on sleep quality
Scientific Title
A study to evaluate the effects of consumption of the test beverage on sleep quality
Scientific Title:Acronym
A study to evaluate the effects of consumption of the test beverage on sleep quality
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of consumption of the test beverage on sleep quality
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OSA sleep inventory MA version
Key secondary outcomes
St. Mary's Hospital Sleep Questionnaire, activity tracker
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of test food for two week (one bottle a day)
Interventions/Control_2
Consumption of placebo for two week (one bottle a day)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Males and females whose age of 20 years or more and less than 65 years
2) Subjects who have complaints for sleep
3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria
1) Subjects receiving a medical treatment for sleep disorders
2) Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
3) Subjects receiving a medical treatment for chronic diseases such as diabetes, hypertension and dyslipidemia
4) Subjects whose lifestyles are irregular because of night shift or others
5) Subjects having some problems in nocturnal sleep occurred from past irregular shift work
6) Subjects waking up for urination 2 times or more during nocturnal sleep
7) Subjects living with their infants less than 1 year old
8) Subjects sleeping with others in the same bedroom
9) Subjects drinking a lot (Subjects whose pure alcohol intake per day is 60 g or more)
10) Subjects regularly taking medicines and quasi-drugs having the effects on sleep quality
11) Subjects regularly taking Food with Functional Claims having the effects on sleep quality
12) Subjects who have severe allergic rhinitis.
13) Subjects having the possibility of developing allergic symptoms by the test food
14) Female subjects who are pregnant or lactating, or intending to become pregnant during the study
15) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
16) Subjects deemed unsuitable by the investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ishimoto |
Organization
Ezaki Glico Co., Ltd.
Division name
Applied Research Laboratory
Zip code
555-8502
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka-shi, Osaka
TEL
050-1751-2061
hiroshi.ishimoto@glico.com
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Sugino |
Organization
Soiken Inc.
Division name
R&D Division
Zip code
560-0082
Address
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka-shi, Osaka
TEL
06-6871-8888
Homepage URL
sugino@soiken.com
Sponsor or person
Institute
Ezaki Glico Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
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
IRB of Fukuda Clinic
Address
Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Tel
06-6398-0203
fukudaclinicIRB@gmail.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
| 2024 | Year | 01 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060878
| 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 |
