UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028501 |
|---|---|
| Receipt number | R000032618 |
| Scientific Title | The influence of milk component and gymnastics on physical function |
| Date of disclosure of the study information | 2017/08/02 |
| Last modified on | 2019/02/01 09:22:44 |
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Basic information
Public title
The influence of milk component and gymnastics on physical function
Acronym
The influence of milk component and gymnastics on physical function
Scientific Title
The influence of milk component and gymnastics on physical function
Scientific Title:Acronym
The influence of milk component and gymnastics on physical function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the influence of milk component and gymnastics on motor units.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
muscle power and motor unit activity before and after the start of the test
Key secondary outcomes
Body composition, blood test (neuromuscular function, cognitive function), cognitive function test and agility before and after the start of the test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intake milk component-containing tablet and perform dairy gymnastics for 4 weeks
Interventions/Control_2
Intake placebo tablet and perform dairy gymnastics for 4 weeks
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
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females
Key exclusion criteria
An allergy to milk
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyasu Ota |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7450
ota.noriyasu@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sayaka Hosoi |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7817
Homepage URL
hosoi.sayaka@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Address
Tel
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
花王株式会社（栃木県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 02 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 17 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 02 | Day |
Last modified on
| 2019 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032618
