UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033932
Receipt number R000038701
Scientific Title Effect of combination of milk derived component and exercise on neuromuscular function
Date of disclosure of the study information 2018/09/01
Last modified on 2020/03/10 07:29:43

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Basic information

Public title

Effect of combination of milk derived component and exercise on neuromuscular function

Acronym

Milk derived component and neuromuscular function

Scientific Title

Effect of combination of milk derived component and exercise on neuromuscular function

Scientific Title:Acronym

Milk derived component and neuromuscular function

Region

Japan


Condition

Condition

Healthy older adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to clarify effect of combination of milk derived component and exercise on neuromuscular function

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

-Maximal strength of knee extensor
-Cross sectional area of quadriceps femoris
-Electromyography and motor unit activation pattern of quadriceps femoris in knee extensor
-Questionnaires

Key secondary outcomes

-Electromyography and motor unit activation pattern of quadriceps femoris in knee extensor
-Questionnaires


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


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Isometric knee extension training with active food

Interventions/Control_2

Isometric knee extension training with placebo food

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

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Who volunteered to this trial in response to a letter of recruitment from the lead principal investigator

Key exclusion criteria

Who restricted exercise by medical doctors, has milk allergy

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kohei Watanabe

Organization

Chukyo University

Division name

School of International Liberal Studies

Zip code


Address

101-2 Yagotohonmachi, Showa-ku, Nagoya, Aichi

TEL

0528357941

Email

wkohei@lets.chukyo-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name HIROAKI MIYOSHI

Organization

Chukyo University

Division name

Research support office

Zip code


Address

101-2

TEL

0528357941

Homepage URL


Email

kenkyurinri@mng.chukyo-u.ac.jp


Sponsor or person

Institute

Chukyo University

Institute

Department

Personal name



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

中京大学(愛知県)


Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 01 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


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 08 Month 09 Day

Date of IRB

2017 Year 07 Month 18 Day

Anticipated trial start date

2018 Year 09 Month 01 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2019 Year 07 Month 30 Day

Date analysis concluded

2019 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2018 Year 08 Month 29 Day

Last modified on

2020 Year 03 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038701


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name