UMIN-CTR Clinical Trial

Basic information
Public title	Motor-function recovering effect verification of effect of milk constituent content food.
Acronym	Motor-function recovering effect verification of effect of milk constituent content food.
Scientific Title	Motor-function recovering effect verification of effect of milk constituent content food.
Scientific Title:Acronym	Motor-function recovering effect verification of effect of milk constituent content food.
Region	Japan

Condition
Condition	People under certified long-term care 2.
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate the motor-function recovering verification of milk constituent content food for elderly people certified long-term support and care.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of TUG before and after ingestion of investigation food and exercise.
Key secondary outcomes	Evaluation of grip, the movable region of a shoulder, one-leg standing duration with vision before and after ingestion of investigation food and exercise. Evaluation of prior questionnaire (listening comprehension of the state of the body before intervention) and post questionnaire (listening comprehension about effect feelings).

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food Behavior,custom
Interventions/Control_1	1. Take in milk constituent content food for 30 days to one bag per day, and arbitrary timing every day. 2. During the investigation, exercise with store staff when use store.
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. People who use day care institution (either the store or the other). 2. People under certified long-term care 2. 3. People who can do unassisted walking (those who can reach the two-step of a pick-up station wagon without care).
Key exclusion criteria	1. People who can't understand directions by dementia. 2. People with milk or orange allergy. 3. People whose the stomach growls loose when drink milk. 4. People who is difficult to bite or take in chewable tablet.
Target sample size	85

Research contact person
Last name of lead principal investigator	1st name Youko Middle name Last name Sugiura
Organization	Kao Corporation
Division name	Healthcare Food Research
Zip code	131-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL	+81-3-5630-7464
Email	sugiura.yoko@kao.com

Public contact
1st name of contact person	1st name Asuka Middle name Last name Ikee
Organization	Kao Corporation
Division name	Healthcare Food Research
Zip code	131-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL	+81-3-5630-7464
Homepage URL
Email	ikee.asuka@kao.com

Sponsor
Institute	Incorporated company Internet infinity
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Human Research Ethics Committee, Kao Corporation
Address	Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel	+81-3-5630-9220
Email	uesaka.toshio@kao.com

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	通所介護施設2店舗（東京都内）／2 store of day care institution (Tokyo)

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 23 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	36
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	2018 Year 03 Month 28 Day
Date of IRB	2018 Year 03 Month 28 Day
Anticipated trial start date	2018 Year 04 Month 23 Day
Last follow-up date	2018 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 03 Day
Last modified on	2019 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036599