UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	validation of the effect of the intake of salmon extract in muscle fatigue
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Naomi Omi
Organization	University of Tsukuba
Division name	Faculty of Health and Sport Sciences, Sports and Exercise Nutrition
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	Tatsuya Konishi
Organization	Maruha Nichiro Corporation
Division name	Central Research Institute
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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 01 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 15 Day
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

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Publication of results	Unpublished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