UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032081 |
|---|---|
| Receipt number | R000036599 |
| Scientific Title | Motor-function recovering effect verification of effect of milk constituent content food. |
| Date of disclosure of the study information | 2018/04/23 |
| Last modified on | 2019/04/05 09:19:47 |
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Basic information
Public title
Motor-function recovering effect verification of effect of milk constituent content food.
Acronym
Motor-function recovering effect verification of effect of milk constituent content food.
Scientific Title
Motor-function recovering effect verification of effect of milk constituent content food.
Scientific Title:Acronym
Motor-function recovering effect verification of effect of milk constituent content food.
Region
| Japan |
Condition
Condition
People under certified long-term care 2.
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the motor-function recovering verification of milk constituent content food for elderly people certified long-term support and care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of TUG before and after ingestion of investigation food and exercise.
Key secondary outcomes
Evaluation of grip, the movable region of a shoulder, one-leg standing duration with vision before and after ingestion of investigation food and exercise.
Evaluation of prior questionnaire (listening comprehension of the state of the body before intervention) and post questionnaire (listening comprehension about effect feelings).
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
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
1. Take in milk constituent content food for 30 days to one bag per day, and arbitrary timing every day.
2. During the investigation, exercise with store staff when use store.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. People who use day care institution (either the store or the other).
2. People under certified long-term care 2.
3. People who can do unassisted walking (those who can reach the two-step of a pick-up station wagon without care).
Key exclusion criteria
1. People who can't understand directions by dementia.
2. People with milk or orange allergy.
3. People whose the stomach growls loose when drink milk.
4. People who is difficult to bite or take in chewable tablet.
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Youko |
| Middle name | |
| Last name | Sugiura |
Organization
Kao Corporation
Division name
Healthcare Food Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7464
sugiura.yoko@kao.com
Public contact
Name of contact person
| 1st name | Asuka |
| Middle name | |
| Last name | Ikee |
Organization
Kao Corporation
Division name
Healthcare Food Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7464
Homepage URL
ikee.asuka@kao.com
Sponsor or person
Institute
Incorporated company Internet infinity
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9220
uesaka.toshio@kao.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
通所介護施設2店舗（東京都内）／2 store of day care institution (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 23 | 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
36
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
| 2018 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 03 | Day |
Last modified on
| 2019 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036599
| 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 |
