UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018564 |
|---|---|
| Receipt number | R000021485 |
| Scientific Title | The effect of milk components on physical function, a randomized controlled trial. |
| Date of disclosure of the study information | 2015/08/11 |
| Last modified on | 2018/08/08 09:59:54 |
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Basic information
Public title
The effect of milk components on physical function, a randomized controlled trial.
Acronym
The effect of milk components on physical function.
Scientific Title
The effect of milk components on physical function, a randomized controlled trial.
Scientific Title:Acronym
The effect of milk components on physical function.
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of improvement on physical functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
physical functions on 6, 12, 18 and 24th weeks of the study
Key secondary outcomes
parameters related to physical functions
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
YES
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
| Food |
Interventions/Control_1
Intake of milk fat globular proteins
6 tablets per day, once a day, 24 weeks
Interventions/Control_2
Intake of milk componets without milk fat globular proteins
6 tablets per day, once a day, 24 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
| 50 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healhy adults with habit of daily exercise
Key exclusion criteria
some one who has one of the followings,
some one suffering from cardial disease or orthopedic disease.
some one who has allergy for milk or orenge.
some one who is pregnant, breastfeeding or possibly pregnant.
some one who is positive for hepatitis B or C test.
Target sample size
115
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Kokai |
Organization
Sapporo Medical University
Division name
School of Medicine
Zip code
Address
S1W17, chuo-ku, Sapporo, Japan
TEL
011-611-2111
kokai@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Kokai |
Organization
Sapporo Medical University
Division name
School of Medicine
Zip code
Address
S1W17, chuo-ku, Sapporo, Japan
TEL
011-611-2111
Homepage URL
kokai@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
札幌医科大学
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29721316
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
| 2015 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 06 | Day |
Last modified on
| 2018 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021485
| Research Plan | |
|---|---|
| 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 |
