UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049568 |
|---|---|
| Receipt number | R000056415 |
| Scientific Title | Effects of fish protein ingestion on neuromuscular and muscle mass adaptation in humans |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2023/05/22 09:10:40 |
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Basic information
Public title
Effects of fish protein ingestion on neuromuscular and muscle mass adaptation in humans
Acronym
Effects of fish protein ingestion on neuromuscular and muscle mass adaptation in humans
Scientific Title
Effects of fish protein ingestion on neuromuscular and muscle mass adaptation in humans
Scientific Title:Acronym
Effects of fish protein ingestion on neuromuscular and muscle mass adaptation in humans
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of fish protein ingestion on muscle mass and neuromuscular adaptation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neuromuscular properties
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Fish protein
Interventions/Control_2
Placebo (whey protein)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
History of neuromuscular disorders or surgery involving their legs
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Watanabe |
Organization
Chukyo University
Division name
School of Health and Sport Sciences
Zip code
4700393
Address
101 Tokodachi, Kaizu-cho, Toyota, Aichi, JAPAN
TEL
0565-46-6599
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
School of Health and Sport Sciences
Zip code
4700393
Address
101 Tokodachi, Kaizu-cho, Toyota, Aichi, JAPAN
TEL
0565-46-6599
Homepage URL
wkohei@lets.chukyo-u.ac.jp
Sponsor or person
Institute
School of Health and Sport Sciences, Chukyo University
Institute
Department
Personal name
Funding Source
Organization
Nippon Suisan Kaisha, Ltd.
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
Research Ethics Committee of Chukyo University
Address
101 Tokodachi, Kaizu-cho, Toyota, Aichi, JAPAN
Tel
0565-46-6150
kenkyurinri@ml.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
| 2022 | Year | 12 | 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
36
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
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 21 | Day |
Last modified on
| 2023 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056415
