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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016714
Receipt No. R000019393
Scientific Title Effect of ingestion of eicosapentaenoic acid-rich fish oil on exercise performance in swimming
Date of disclosure of the study information 2015/03/10
Last modified on 2016/05/09

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Basic information
Public title Effect of ingestion of eicosapentaenoic acid-rich fish oil on exercise performance in swimming
Acronym Effect of EPA on exercise performance in swimming
Scientific Title Effect of ingestion of eicosapentaenoic acid-rich fish oil on exercise performance in swimming
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Shigehiro Takahashi
Organization Chukyo University
Division name School of Health and Sport Science
Zip code
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
1st name
Middle name
Last name Shigehiro Takahashi
Organization Chukyo University
Division name School of Health and Sport Science
Zip code
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

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)

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 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

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
2015 Year 02 Month 09 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000019393

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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