UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016714 |
|---|---|
| Receipt number | 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 16:18:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
stakahas@cnc.chukyo-u.ac.jp
Sponsor or person
Institute
Chukyo University School of Health and Sport Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019393
