UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038003 |
|---|---|
| Receipt number | R000042572 |
| Scientific Title | Influence of ingestion of eicosapentaenoic acid-rich fish oil on muscle damage and delayed onset muscle soreness following eccentric contractions: a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2019/09/13 |
| Last modified on | 2021/07/26 14:59:58 |
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Basic information
Public title
Influence of ingestion of eicosapentaenoic acid-rich fish oil on muscle damage and delayed onset muscle soreness following eccentric contractions: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym
Influence of eicosapentaenoic acid on muscle damage and delayed onset muscle soreness
Scientific Title
Influence of ingestion of eicosapentaenoic acid-rich fish oil on muscle damage and delayed onset muscle soreness following eccentric contractions: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
Influence of eicosapentaenoic acid on muscle damage and delayed onset muscle soreness
Region
| Japan |
Condition
Condition
muscle damage and delayed onset muscle soreness
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the influence of eicosapentaenoic acid for muscle damage and delayed onset muscle soreness following eccentric contractions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
After ingestion of tested materials for 4 weeks, subjects perform eccentric contraction ( ECC ) with elbow flexors. Before and after ECC,
1) Range of motion
2) Maximal isometric contraction torque
3) Muscle soreness measured as a visual analog scale
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
Tested material: EPA-rich fish oil
Dosage: 2.4g/day
Duration: 4 weeks
Interventions/Control_2
Tested material: corn oil
Dosage: 2.4g/day
Duration: 4 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
Key inclusion criteria
Healthy male subjects
Key exclusion criteria
Subjects with
/resistance training more than five times a week for a year /no resistance training or exercise during over a year /serious liver, kidney, heart, respiratory, endocrine or metabolic diseases/ scheduled for surgery during this study/ administration of regular medication/ regular administration of supplements which affect this study / food allergies/ participation of other clinical trial during this study/ restriction of exercise/ any reason in the opinion of the lead principal investigator not to take part in this study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Eisuke |
| Middle name | |
| Last name | Ochi |
Organization
Hosei University
Division name
Faculty of Bioscience and Applied Chemistry
Zip code
1848584
Address
3-7-2 Kajino, Koganei, Tokyo
TEL
042-387-6337
ochi@hosei.ac.jp
Public contact
Name of contact person
| 1st name | Eisuke |
| Middle name | |
| Last name | Ochi |
Organization
Hosei University
Division name
Faculty of Bioscience and Applied Chemistry
Zip code
1848584
Address
3-7-2 Kajino, Koganei, Tokyo
TEL
042-387-6337
Homepage URL
ochi@hosei.ac.jp
Sponsor or person
Institute
Hosei University
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
Teikyo Heisei University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Teikyo Heisei University
Address
Higashiikebukuro, Toshima, Tokyo, Japan
Tel
03-5843-3152
rec@thu.ac.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
法政大学生命科学部（東京都）（Hosei Univesity）
帝京平成大学（東京都）（Teikyo Heisei Univesity）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
https://jissn.biomedcentral.com/articles/10.1186/s12970-021-00411-x
Publication of results
Published
Result
URL related to results and publications
https://jissn.biomedcentral.com/articles/10.1186/s12970-021-00411-x
Number of participants that the trial has enrolled
22
Results
ROM was significantly higher in the EPA and DHA group than in the PL group immediately after performing ECCs (p？<？0.05). A significant difference was observed in serum CK 3 days after ECCs (p？<？0.05).
Results date posted
| 2021 | Year | 07 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy young men
Participant flow
Twenty-two untrained men were recruited in this double-blind, placebo-controlled, parallel design study and the subjects were randomly assigned to the EPA and DHA group (EPA and DHA, n？=？11) and placebo group (PL, n？=？11). They consumed either EPA 600 mg and DHA 260 mg per day or placebo supplement for 4 weeks prior to exercise. Subjects performed 60 ECCs at 100？% maximal voluntary contraction (MVC) using a dumbbell. Changes in MVC torque, range of motion (ROM), upper arm circumference, muscle soreness, echo intensity, muscle thickness, serum creatine kinase (CK), and interleukin-6 (IL-6) were assessed before exercise; immediately after exercise; and 1, 2, 3, and 5 days after exercise.
Adverse events
None
Outcome measures
MVC torque, range of motion (ROM), serum creatine kinase (CK), and interleukin-6 (IL-6)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 13 | Day |
Last modified on
| 2021 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042572
