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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020588
Receipt No. 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

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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
Email 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
Email t-konishi@maruha-nichiro.co.jp

Sponsor
Institute Maruha Nichiro Corporation
University of Tsukuba
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023295

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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