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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023869
Receipt No. R000027494
Scientific Title Effect of Alaska pollock protein intake and resistance training on lower extremity muscle functions
Date of disclosure of the study information 2016/09/01
Last modified on 2019/04/03

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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 No longer recruiting
Date of protocol fixation
2016 Year 08 Month 02 Day
Date of IRB
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
2019 Year 04 Month 03 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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