UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036396
Receipt number R000041466
Scientific Title Effect of Alaska pollock protein intake and resistance training on lower extremity muscle functions and motor unit activation properties
Date of disclosure of the study information 2019/04/10
Last modified on 2019/04/03 13:05:49

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Basic information

Public title

Effect of Alaska pollock protein intake and resistance training on lower extremity muscle functions and motor unit activation properties

Acronym

Effect of Alaska pollock protein intake and resistance training on lower extremity muscle functions and motor unit activation properties

Scientific Title

Effect of Alaska pollock protein intake and resistance training on lower extremity muscle functions and motor unit activation properties

Scientific Title:Acronym

Effect of Alaska pollock protein intake and resistance training on lower extremity muscle functions and motor unit activation properties

Region

Japan


Condition

Condition

Healthy

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of fish protein intake and resistance training on muscle strength and motor unit activation properties

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Maximal knee extension joint force, Muscle volume of knee extensors (Ultrasonography), Muscle volume of lower limb (Body Impedance), Motor unit activation of knee extensor muscle (Electromyography)
2wk before intervention, Beginning of intervention, 2wk after intervention, 4wk after intervention, 6wk after intervention, 8wk after intervention

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food Behavior,custom

Interventions/Control_1

Casein 4.5g/day/every day
Resistance training 2 days/wk
8weeks

Interventions/Control_2

FIsh protein 4.5g/day/every day
Resistance training 2 days/wk
8weeks

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

Person who is not restricted exercise by medical doctor

Key exclusion criteria

Person who has habituation of high intensity resistance training

Target sample size

50


Research contact person

Name of lead principal investigator

1st name KOHEI
Middle name
Last name WATANABE

Organization

Chukyo University

Division name

School of International Liberal Studies

Zip code

4668666

Address

Yagotohonmachi 101-2, Showaku,

TEL

+81528357941

Email

wkohei@lets.chukyo-u.ac.jp


Public contact

Name of contact person

1st name KOHEI
Middle name
Last name WATANABE

Organization

Chukyo University

Division name

Research support office

Zip code

4668666

Address

Yagotohonmachi 101-2, Showaku,

TEL

+81528357941

Homepage URL


Email

wkohei@lets.chukyo-u.ac.jp


Sponsor or person

Institute

Chukyo University

Institute

Department

Personal name



Funding Source

Organization

Nippon Suisan Kaisha

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Aichi


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chukyo University

Address

101-2

Tel

+81528357941

Email

kenkyurinri@mng.chukyo-u.ac.jp


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



Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 10 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

Open public recruiting

Date of protocol fixation

2019 Year 04 Month 01 Day

Date of IRB

2015 Year 07 Month 29 Day

Anticipated trial start date

2019 Year 04 Month 02 Day

Last follow-up date

2019 Year 12 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

2019 Year 04 Month 03 Day

Last modified on

2019 Year 04 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041466


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name