UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023869 |
|---|---|
| Receipt number | 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 | 2020/03/04 10:46:37 |
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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
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
kenkyurinri@mng.chukyo-u.ac.jp
Sponsor or person
Institute
Chukyo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027494
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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