UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of milk components on physical function, a randomized controlled trial.
Title of the study (Brief title)	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	Yasuo Kokai
Organization	Sapporo Medical University
Division name	School of Medicine
Address	S1W17, chuo-ku, Sapporo, Japan
TEL	011-611-2111
Email	kokai@sapmed.ac.jp

Public contact
Name of contact person	Yasuo Kokai
Organization	Sapporo Medical University
Division name	School of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/29721316
Results
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/icdr_e/ctr_view.cgi?recptno=R000021485