UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045108 |
|---|---|
| Receipt number | R000051532 |
| Scientific Title | Survey of senior citizens after injectioning monitor foods |
| Date of disclosure of the study information | 2021/08/16 |
| Last modified on | 2021/08/10 14:00:13 |
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Basic information
Public title
Survey of senior citizens after injectioning monitor foods
Acronym
Survey of senior citizens after injectioning monitor foods
Scientific Title
Survey of senior citizens after injectioning monitor foods
Scientific Title:Acronym
Survey of senior citizens after injectioning monitor foods
Region
| Japan |
Condition
Condition
Senior citizens
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the usability of the monitor foods when it is consumed by the senior citizens, and to obtain reference information for product brand development.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The usability of the monitor foods
Key secondary outcomes
Acceptance and evaluation of the monitor foods
Daily diary (physical condition, intake of the monitor foods, etc.)
Participant background (age, medical history, allergies, stress etc.)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
30 days intake of monitor food
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Subjects who have obtained written consent for participation in the survey.
2)Men and women between 65 and 79.
3)Subjects who have a family doctor whom they can consult in case of illness or injury, and who are in daily contact with their family doctor.
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)Subjects who have high stress level
4)Subjects who are estimated inappropriate to this survey by principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Ikeda |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
AIR Project
Zip code
108-8241
Address
Shinagawa Grand Central Tower, 2-16-4, Konan, Minato-ku, Tokyo
TEL
03-6717-1499
Ikeda.Yasutaka@otsuka.jp
Public contact
Name of contact person
| 1st name | Rikichika |
| Middle name | |
| Last name | Kawata |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
AIR Project
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
| 2021 | Year | 08 | Month | 16 | 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
| 2021 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | 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
| 2021 | Year | 08 | Month | 10 | Day |
Last modified on
| 2021 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051532
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
