UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	validation study of the anti-fatigue effects of Salmon extra containing anserine for the person performing daily exercise
Title of the study (Brief title)	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	Kenichi Itao
Organization	WIN Frontier Co., Ltd.
Division name	WIN Frontier Co., Ltd.
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	Tatsuya Konishi
Organization	Maruha Nichiro Corporation
Division name	Central Research Institute
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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