UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Combination effect of milk ingredients and the external preparation for skin on physical function in healthy Japanese.
Title of the study (Brief title)	Combination effect of milk ingredients and the external preparation for skin on physical function in healthy Japanese.
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 combination effect of milk ingredients and the external preparation for skinactive gel-cream on physical function in healthy Japanese.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Sense of balance, agility, muscle strength, and motor unit activity at the beginning of the trial, one month later, and two months later of the dairy intake of milk ingredients containing tablets and the application of the external preparation to the skin.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
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 Other
Interventions/Control_1	Dairy intake of milk ingredients (1 g/day) containing tablets for 2 months. Exercise on a treadmill (15 min) twice a week for 2 months. Exercise on a bicycle ergometer (15min) twice a week for 2 months. Apply the external preparation to the skin in thighs of both legs before the exercise.
Interventions/Control_2	Dairy intake of milk ingredients (1 g/day) containing tablets for 2 months. Exercise on a treadmill (15 min) twice a week for 2 months. Exercise on a bicycle ergometer (15min) twice a week for 2 months. Apply the external preparation (placebo) to the skin in thighs of both legs before the exercise.
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	80 years-old >
Gender	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	55

Research contact person
Name of lead principal investigator	Noriyasu Ota
Organization	Kao Corporation
Division name	Biological Science Laboratories
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7828
Email	ota.noriyasu@kao.co.jp

Public contact
Name of contact person	Satoshi Sugita
Organization	Kao Corporation
Division name	Biological Science Laboratories
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7769
Homepage URL
Email	sugita.satoshi@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	医療法人北斗会宇都宮東病院（栃木県）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 13 Day
Anticipated trial start date	2016 Year 07 Month 31 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 26 Day
Last modified on	2016 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026887