UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Alaska pollock protein intake and resistance training on lower extremity muscle functions
Acronym	Effect of APP intake and resistance training on lower extremity muscle functions
Scientific Title	Effect of Alaska pollock protein intake and resistance training on lower extremity muscle functions
Scientific Title:Acronym	Effect of APP intake and resistance training on lower extremity muscle functions
Region	Japan

Condition
Condition	Sarcopenia Locomotive syndrome
Classification by specialty	Orthopedics Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate effect of Alaska pollock protein intake and resistance training on locomotion function and lower limb muscle function in young and older adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gait speed (10m), 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) 3wk before intervention, Beginning of intervention, 3wk after intervention, 6wk after intervention or 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	4
Purpose of intervention	Treatment
Type of intervention	Food Behavior,custom
Interventions/Control_1	Alaska pollock protein intake (4.5g / day/ every day) 6wk or 8wk
Interventions/Control_2	Resistance training (Leg press)(2 days/ wk) with placebo intake (every day) 6wk or 8wk
Interventions/Control_3	Alaska pollock protein intake (4.5g / day/ every day) and Resistance training (Leg press)(2 days/ wk) 6wk or 8wk
Interventions/Control_4	Control with placebo intake (every day) 6wk or 8wk
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	95 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	60

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	101-2 Yagotohonmachi, Showaku, Nagoya, Aichi
TEL	052-835-7941
Email	wkohei@lets.chukyo-u.ac.jp

Public contact
Name of contact person	1st name Tetsuzo Middle name Last name Suzuki
Organization	Chukyo University
Division name	Research support office
Zip code	4668666
Address	101-2 Yagotohonmachi, Showaku, Nagoya, Aichi
TEL	052-835-7941
Homepage URL
Email	kenkyurinri@mng.chukyo-u.ac.jp

Sponsor
Institute	Chukyo University
Institute
Department

Funding Source
Organization	Japanese Council for Science, Technology and Innovation (CSTI),Cross-ministerial Strategic Innovation Promotion Program
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Nippon Suisan Kaisha, Ltd.

IRB Contact (For public release)
Organization	Chukyo University
Address	Yagotohonmachi 101-2, Showaku,
Tel	+81528357941
Email	wkohei@lets.chukyo-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2016-006-2
Org. issuing International ID_1	Nippon Suisan Kaisha, Ltd.
Study ID_2	2015-002
Org. issuing International ID_2	Chukyo University
IND to MHLW

Institutions
Institutions	中京大学八事キャンパス

Other administrative information
Date of disclosure of the study information	2016 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	2016 Year 08 Month 02 Day
Date of IRB	2015 Year 07 Month 29 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date	2017 Year 04 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 08 Month 31 Day
Last modified on	2020 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027494