UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056261 |
|---|---|
| Receipt number | R000064279 |
| Scientific Title | A study on the effects of eicosapentaenoic acid-rich fish oil on exercise performance and conditioning in runners |
| Date of disclosure of the study information | 2024/12/08 |
| Last modified on | 2024/11/25 11:33:42 |
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Basic information
Public title
Study on the effects of eicosapentaenoic acid on exercise performance and conditioning
Acronym
Study on the effects of eicosapentaenoic acid on exercise performance and conditioning
Scientific Title
A study on the effects of eicosapentaenoic acid-rich fish oil on exercise performance and conditioning in runners
Scientific Title:Acronym
Study on the effects of eicosapentaenoic acid on exercise performance and conditioning in runners
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine whether the intake of eicosapentaenoic acid-rich fish oil influences exercise performance and conditioning during regular training and races.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
evaluation items related to exercise performance
evaluation items related to exercise conditioning
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the EPA-rich oil for 8 weeks.
Interventions/Control_2
Ingestion of the corn oil for 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy exercise practitioners
Key exclusion criteria
Subjects
1) with serious liver, kidney, heart, respiratory, endocrine or metabolic diseases
2) are taking medication for serious diseases listed in 1)
3) with a planned surgery during the trial period
4) who have experienced shock, allergic reactions or anaemia when having blood taken or an injection at a medical institution, etc.
5) who have experienced cerebral anaemia when bleeding normally
6) who have red, swollen mosquito bites that do not heal easily
7) who are allergic to fish or gelatine
8) who regularly take supplements containing EPA and DHA
9) who eat oily fish (mackerel, sardines, etc.) at least four days a week
10) who are participating in other human trials
11) who have not given consent to participate in this trial
12) who the principal investigator has judged to be unsuitable for participation in this trial
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Ichikawa |
Organization
ASICS Corporation
Institute of Sport Science
Division name
Human Attribute Research Department
Zip code
651-2271
Address
6-2-1 Takatsukadai, Nishi-ku, Kobe City, Hyogo Prefecture
TEL
050-1744-3179
masaru.ichikawa@asics.com
Public contact
Name of contact person
| 1st name | Ayano |
| Middle name | |
| Last name | Imai |
Organization
ASICS Corporation Institute of Sport Science
Division name
Human Attribute Research Department
Zip code
651-2271
Address
6-2-1 Takatsukadai, Nishi-ku, Kobe City, Hyogo Prefecture
TEL
050-1744-3572
Homepage URL
marugame2024.epa-iss@asics.com
Sponsor or person
Institute
ASICS Corporation
Institute
Department
Personal name
Funding Source
Organization
ASICS Corporation
Nissui Corporation
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
HealthCare Systems Ethics Review Committee
Address
1-14-18 Shirokane, Showa-ku, Nagoya City, Aichi Prefecture
Tel
052-734-8885
soumu@hc-sys.jp
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
| 2024 | Year | 12 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 25 | Day |
Last modified on
| 2024 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064279
