UMIN-CTR Clinical Trial

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
Email	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
Email	ochi@hosei.ac.jp

Sponsor
Institute	Hosei University
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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042572