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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024005
Receipt No. R000027637
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.
Date of disclosure of the study information 2016/10/01
Last modified on 2016/09/13

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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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