UMIN-CTR Clinical Trial

Public title

Combination effect of milk ingredients and the external preparation for skin on physical function in healthy Japanese.

Acronym

Combination effect of milk ingredients and the external preparation for skin on physical function in healthy Japanese.

Scientific Title

Combination effect of milk ingredients and the external preparation for skin on physical function in healthy Japanese.

Scientific Title:Acronym

Combination effect of milk ingredients and the external preparation for skin on physical function in healthy Japanese.

Region

Japan

Condition

Healthy adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Noriyasu Ota

Organization

Kao Corporation

Division name

Biological Science Laboratories

Zip code

Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

+81-285-68-7828

Email

ota.noriyasu@kao.co.jp

Name of contact person

1st name
Middle name
Last name	Satoshi Sugita

Organization

Kao Corporation

Division name

Biological Science Laboratories

Zip code

Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

+81-285-68-7769

Homepage URL

Email

sugita.satoshi@kao.co.jp

Institute

Kao Corporation

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人北斗会宇都宮東病院（栃木県）

Date of disclosure of the study information

2016

Year

07

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

07

Month

13

Day

Date of IRB

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

Other related information

Registered date

2016

Year

07

Month

26

Day

Last modified on

2016

Year

12

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026887