UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020588 |
|---|---|
| Receipt number | R000023295 |
| Scientific Title | validation of the effect of the intake of salmon extract in muscle fatigue |
| Date of disclosure of the study information | 2016/01/16 |
| Last modified on | 2016/06/15 10:50:45 |
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Basic information
Public title
validation of the effect of the intake of salmon extract in muscle fatigue
Acronym
validation of the effect of the intake of salmon extract in muscle fatigue
Scientific Title
validation of the effect of the intake of salmon extract in muscle fatigue
Scientific Title:Acronym
validation of the effect of the intake of salmon extract in muscle fatigue
Region
| Japan |
Condition
Condition
verification of the antifatigue effect
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This test is intended to validate the antifatigue effects by intake of salmon extract.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Yo-Yo test(endurance test)(0 week and 5week)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of the control product(5week)
Interventions/Control_2
Oral ingestion of the test product(fish sausage containing salmon extract)(5week)
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
Men over 20 years old belonging to the
soccer club of Tsukuba University
Key exclusion criteria
1) Individuals judged inappropriate for the
study by the principal
2) Individuals using medical products
3) Individuals who had a habit to ingest health foods or supplements
4) Individuals who are sensitive to test
products
5) Individuals who have a history of serious
hepatopathy, kidney damage, heart disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naomi Omi |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences, Sports and Exercise Nutrition
Zip code
Address
1-1-1, Tennodai, Tsukuba-city, Ibaraki, 305-8574 Japan
TEL
029-853-6319
ominaomi@taiiku.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Konishi |
Organization
Maruha Nichiro Corporation
Division name
Central Research Institute
Zip code
Address
16-2, Wadai, Tsukuba-Ciy, Ibaraki, 300-4295 Japan
TEL
029-864-6714
Homepage URL
t-konishi@maruha-nichiro.co.jp
Sponsor or person
Institute
Maruha Nichiro Corporation
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Maruha Nichiro Corporation
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
Address
Tel
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
| 2016 | Year | 01 | Month | 16 | 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 | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 15 | Day |
Last modified on
| 2016 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023295
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
