UMIN-CTR Clinical Trial

Basic information
Public title	Dietary milk fat globule membrane with semiweekly light exercise improves choice stepping reaction time in healthy Japanese elderly subjects: A randomized double blind, placebo-controlled trial.
Acronym	Combination effect of milk fat globule membrane and light exercise on agility in healthy Japanese elderly.
Scientific Title	Dietary milk fat globule membrane with semiweekly light exercise improves choice stepping reaction time in healthy Japanese elderly subjects: A randomized double blind, placebo-controlled trial.
Scientific Title:Acronym	Combination effect of milk fat globule membrane and light exercise on agility in healthy Japanese elderly.
Region	Japan

Condition
Condition	Healthy elderly
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the combination effect of milk fat globule membrane intake and light exercise on agility in healthy elderly.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Choice stepping reaction time before and after the 5-week intervention (daily intake of test tablets and semiweekly light exercise)
Key secondary outcomes	Muscle mass before and after the 5-week intervention (daily intake of test tablets and semiweekly light exercise)

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	Food Behavior,custom
Interventions/Control_1	Daily intake of milk fat globule membrane containing tablets, and semiweekly light exercise (30 min/day) for 5 weeks.
Interventions/Control_2	Daily intake of placebo tablets, and semiweekly light exercise (30 min/day) for 5 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	60 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	-A person who hasn't had a motor dysfunction. -A person who is able to participate in a functional fitness test. -A person who hasn't used a cardiac pacemaker and/or an artificial joint.
Key exclusion criteria	-A person who has had severe diseases or the past illness on liver, kidney, heart, lung, digestive organs, blood, endocrine, nerve and metabolic system. -A person who has had severe damage on the locomotive organs such as fracture, tendon rupture, or muscle strain in the past 1 year. -A person who has had dietary allergy. -A person who has taken a lot of milk products. -A person who has had a habit to do strength training. -A person who has been ordered not to do exercise by a medical doctor. -A person who are not eligible due to medical doctor's judgment.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Noriyasu Ota
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Zip code
Address	2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7828
Email	ota.noriyasu@kao.co.jp

Public contact
Name of contact person	1st name Middle name Last name Satoko Soga
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Zip code
Address	2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7828
Homepage URL
Email	soga.satoko@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)

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	北斗会宇都宮東病院（栃木県）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://www.jarcp.com/2905-dietary-milk-fat-globule-membrane-with-semiweekly-light-exercise-improves-
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	2012 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date	2012 Year 09 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2013 Year 05 Month 20 Day
Date analysis concluded	2013 Year 05 Month 20 Day

Other
Other related information

Management information
Registered date	2016 Year 09 Month 12 Day
Last modified on	2016 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027637

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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