UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000028165
Receipt No. R000032244
Scientific Title Influence of ingestion of eicosapentaenoic acid-rich fish oil on muscle stiffness following eccentric contractions: a randomized, double-blind, placebo-controlled, parallel-group trial
Date of disclosure of the study information 2017/07/20
Last modified on 2020/01/11 (Ver. 6)

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Basic information
Public title Influence of ingestion of eicosapentaenoic acid-rich fish oil on muscle stiffness following eccentric contractions: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym Trial of eicosapentaenoic acid on muscle stiffness
Scientific Title Influence of ingestion of eicosapentaenoic acid-rich fish oil on muscle stiffness following eccentric contractions: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym Trial of eicosapentaenoic acid on muscle stiffness
Region
Japan

Condition
Condition muscle stiffness
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is investigating the influence of eicosapentaenoic acid (EPA) for muscle muscle stiffness 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 8 weeks, subjects perform eccentric contraction (ECC) with elbow flexors. Before and after ECC,
1) muscle stiffness
2) range of motion
Key secondary outcomes After ingestion of tested materials for 8 weeks, subjects perform eccentric contraction (ECC) with elbow flexors. Before and after ECC,
1) maximal isometric contraction torque
2) muscle soreness measured as a visual analog scale

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 Prevention
Type of intervention
Food
Interventions/Control_1 Tested material: EPA-rich fish oil
Dosage: 2.4g/day
Duration: 8 weeks
Interventions/Control_2 Tested material: corn oil
Dosage: 2.4g/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

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
Zip code 184-8584
Address 3-7-2 Kajino-cho, Koganei, Tokyo, Japan
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
Zip code 184-8584
Address 3-7-2 Kajino-cho, Koganei, Tokyo, Japan
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
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee of Hosei University Sports Research Center
Address 4342 Aihara-cho, Machida, Tokyo, Japan
Tel 042-783-2732
Email tamatai@hosei.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 Faculty of Bioscience）

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 20 Day

Related information
URL releasing protocol https://jissn.biomedcentral.com
Publication of results Published

Result
URL related to results and publications https://jissn.biomedcentral.com
Number of participants that the trial has enrolled 16
Results 
MVC torque and ROM were significantly higher in the EPA group than in the PL group after ECCs. Muscle soreness, upper arm circumference, and muscle echo intensity were significantly higher in the PL group than in the EPA group after ECCs. In addition, muscle stiffness at 150 deg was significantly higher in the PL group than in the EPA group immediately after ECCs.
Results date posted
2019 Year 04 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
 Healthy men
Participant flow 
Subjects consumed either EPA 600 mg and DHA 260 mg per day or placebo supplement for 8 weeks prior to exercise. Moreover, they performed six sets of 10 ECCs at 100% maximal voluntary contraction (MVC) using a dumbbell. Measuremetns were assessed before exercise; immediately after exercise; and 1, 2, and 5 days after exercise.
Adverse events 
No events
Outcome measures 
Muscle torque, range of motion (ROM), upper arm circumference, muscle soreness, muscle echo intensity, and muscle stiffness
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2017 Year 07 Month 10 Day
Date of IRB
2017 Year 07 Month 07 Day
Anticipated trial start date
2017 Year 07 Month 20 Day
Last follow-up date
2017 Year 09 Month 22 Day
Date of closure to data entry
2017 Year 11 Month 23 Day
Date trial data considered complete
2017 Year 12 Month 30 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 10 Day
Last modified on
2020 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032244