UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047122 |
|---|---|
| Receipt number | R000053753 |
| Scientific Title | A preliminary survey to determine the effect of different timing of intake of monitor products on the level of fulfillment in daily life. |
| Date of disclosure of the study information | 2022/03/09 |
| Last modified on | 2022/10/21 09:12:46 |
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Basic information
Public title
A preliminary survey to determine the effect of different timing of intake of monitor products on the level of fulfillment in daily life.
Acronym
A preliminary survey to determine the effect of different timing of intake of monitor products on the level of fulfillment in daily life.
Scientific Title
A preliminary survey to determine the effect of different timing of intake of monitor products on the level of fulfillment in daily life.
Scientific Title:Acronym
A preliminary survey to determine the effect of different timing of intake of monitor products on the level of fulfillment in daily life.
Region
| Japan |
Condition
Condition
Workers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain preliminary information for a study to determine the effect of different timing of intaking monitor products on the fulfillment of daily life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire on Sleep
Key secondary outcomes
Questionnaire on fulfillment in daily life
Questionnaire for Complaints
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
14 days intake of monitor product after breakfast
Interventions/Control_2
14 days intake of monitor product after dinner
Interventions/Control_3
14 days intake of monitor product after breakfast and after dinner
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Subjects who have obtained written consent for participation in the survey.
2)Healthy adult males and females (Those who have not had a medical checkup within the past year and do not have any items that require further examination. However, those who have been diagnosed as not requiring treatment as a result of a detailed examination may participate
3)Worker
4)Those who are able to intake the monitor product and answer the questionnaire according to the predetermined schedule..
Key exclusion criteria
1)Subjects who had a serious major organ / internal organ or who are currently undergoing treatment and who are estimated inappropriate to this study.
2)Subjects who have food allergies.
3)Pregnant and lactating women
4)Subjects who are estimated inappropriate to this survey by principal investigator.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Hamada |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Yoshinogari-cho Kanzaki-gun, Saga,
TEL
0952-52-1522
hamadako@otsuka.jp
Public contact
Name of contact person
| 1st name | Rikichika |
| Middle name | |
| Last name | Kawata |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Societal Health Relations Department
Zip code
108-8241
Address
Shinagawa Grand Central Tower, 2-16-4, Konan, Minato-ku, Tokyo
TEL
03-6717-1499
Homepage URL
kawatar@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical 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
Otsuka Pharmaceutical Co., Ltd.
Address
Shinagawa Grand Central Tower, 2-16-4, Konan, Minato-ku, Tokyo
Tel
03-6717-1499
shimizu_se@otsuka.jp
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
| 2022 | Year | 03 | Month | 09 | 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
245
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
| 2022 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 09 | Day |
Last modified on
| 2022 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053753
