UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of ingestion of eicosapentaenoic acid-rich fish oil on exercise performance in swimming
Title of the study (Brief title)	Effect of EPA on exercise performance in swimming
Region	Japan

Condition
Condition	Exercise performance
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is investigating the effect of EPA-rich fish oil on exercise performance for oxygen uptake and blood lactate concentration during swimming.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Oxygen uptake 2. Blood lactate concentration
Key secondary outcomes	1. Respiratory quotient 2. Swimming records 3. Blood test (triglyceride , free fatty acids, ketone, glucose, urea nitrogen, creatine kinase, myoglobin,IL-6, TNF-alpha) 4. Body composition (weight, body fat percentage, lean body mass) 5. Thermography before and after swimming 6. Visual analog scale for fatigue

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	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	Tested material: EPA-rich fish oil Dosage: 4.8g/day Duration: 8weeks
Interventions/Control_2	Tested material: Corn oil Dosage: 4.8g/day Duration: 8 weeks
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	18 years-old <=
Age-upper limit	22 years-old >=
Gender	Male
Key inclusion criteria	Swimmers or subjects with swimming experience, Healthy subjects
Key exclusion criteria	Subjects scheduled for surgery during this study, Subjects with serious diseases, Subjects with administration of anticoagulants, Subjects with food allergies to fish, Subjects with any reason in the opinion of the lead principal investigator not to take part in this study
Target sample size	20

Research contact person
Name of lead principal investigator	Shigehiro Takahashi
Organization	Chukyo University
Division name	School of Health and Sport Science
Address	101 Tokodachi, Kaizu-cho, Toyota-shi, Aichi, Japan
TEL	0565-46-6567
Email	stakahas@cnc.chukyo-u.ac.jp

Public contact
Name of contact person	Shigehiro Takahashi
Organization	Chukyo University
Division name	School of Health and Sport Science
Address	101 Tokodachi, Kaizu-cho, Toyota-shi, Aichi, Japan
TEL	0565-46-6567
Homepage URL
Email	stakahas@cnc.chukyo-u.ac.jp

Sponsor
Institute	Chukyo University School of Health and Sport Science
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	Nippon Suisan Kaisha, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	中京大学スポーツ科学部（愛知県）　　Chukyo University School of Health and Sport Science (Aichi Pref.)

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 09 Day
Anticipated trial start date	2015 Year 02 Month 25 Day
Last follow-up date	2015 Year 05 Month 31 Day
Date of closure to data entry	2015 Year 06 Month 10 Day
Date trial data considered complete	2015 Year 06 Month 20 Day
Date analysis concluded	2015 Year 07 Month 31 Day

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

Management information
Registered date	2015 Year 03 Month 05 Day
Last modified on	2016 Year 05 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019393