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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018564
Receipt No. 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

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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
Email 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
Email kokai@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021485

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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