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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022743
Receipt No. R000025249
Scientific Title validation study of the anti-fatigue effects of Salmon extra containing anserine for the person performing daily exercise
Date of disclosure of the study information 2016/07/19
Last modified on 2016/08/17

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Basic information
Public title validation study of the anti-fatigue effects of Salmon extra containing anserine for the person performing daily exercise
Acronym the anti-fatigue effects of Salmon extra containing anserine
Scientific Title validation study of the anti-fatigue effects of Salmon extra containing anserine for the person performing daily exercise
Scientific Title:Acronym the anti-fatigue effects of Salmon extra containing anserine
Region
Japan

Condition
Condition validation of the anti-fatigue effects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This test is intended to validate the anti-fatigue effects of the person performing daily exercise by intake of salmon extract containing anserine.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes performance test (shot of tennis) 2week after
Key secondary outcomes Obstructive Sleep Apnoea(OSA)
POMS
Pulse wave
Heart rate
amylase activating in saliva

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 Treatment
Type of intervention
Food
Interventions/Control_1 Oral ingestion of the control product(2week)
Interventions/Control_2 Oral ingestion of the test product(jelly
containing anserine)(2week)
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
50 years-old >
Gender Male and Female
Key inclusion criteria Continued tennis rally is more than 10 times
Key exclusion criteria 1) Individuals judged inappropriate for the study by the principal
2) Individuals using medical products( sleeping drug)
3) Individuals who had a habit to ingest health foods or supplements(Sleep improvement functional food)
4) Individuals who are sensitive to test products
5) Individuals who have a history of serious hepatopathy, kidney damage, heart disease
6) Smoker
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Itao
Organization WIN Frontier Co., Ltd.
Division name WIN Frontier Co., Ltd.
Zip code
Address 247 Shin-Yurakucho Building, 1-12-1 Yurakucho, Chiyoda-ku, Tokyo, 100-0006 Japan
TEL 03-6266-2050
Email kenichi.itao@winfrontier.com

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-City, Ibaraki, 300-4295 Japan
TEL 029-864-6712
Homepage URL
Email t-konishi@maruha-nichiro.co.jp

Sponsor
Institute WIN Frontier Co., Ltd.
Maruha Nichiro Corporation
Specified Nonprofit Corporation Palm International Shonan
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 07 Month 19 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 05 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 05 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 06 Month 15 Day
Last modified on
2016 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025249

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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