UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The influence of milk component and gymnastics on physical function
Title of the study (Brief title)	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	Noriyasu Ota
Organization	Kao Corporation
Division name	Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7450
Email	ota.noriyasu@kao.co.jp

Public contact
Name of contact person	Sayaka Hosoi
Organization	Kao Corporation
Division name	Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7817
Homepage URL
Email	hosoi.sayaka@kao.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032618