UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018285
Receipt No. R000021165
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 2015/07/14
Last modified on 2020/01/11 (Ver. 10)

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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 investigating the influence of eicosapentaenoic acid (EPA) 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 1. After ingestion of tested materials for 8 weeks, subjects perform eccentric contraction (ECC) with elbow flexors. During ECC,
1) electromyogram
2) isotonic contraction torque

2. After ingestion of tested materials for 8 weeks, subjects perform eccentric contraction (ECC) with elbow flexors. Before and after ECC,
1) ultrasonic imaging analysis for elbow flexors
2) reactivity of electrical micro-stimulation
3) maximal isometric contraction torque
4) range of motion
5)muscle soreness measured as a visual analog scale
6)muscle soreness measured by algesiometer
Key secondary outcomes 1. After ingestion of tested materials for 8 weeks, subjects perform eccentric contraction (ECC) with elbow flexors. During ECC, analyzing ultrasonic imaging for elbow flexors.

2. After ingestion of tested materials for 8 weeks, subjects perform eccentric contraction (ECC) with elbow flexors. Before and after ECC,
testing blood makers (creatine kinase, myoglobin, IL-6, TNF-alpha).

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Healthy male subjects
Key exclusion criteria Subjects with
/regular resistance training /no exercise /serious liver, kidney, heart, respiratory, endocrine or metabolic diseases/ scheduled for surgery during this study/ administration of regular medication / food allergies to fish/ 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 Okayama University
Division name Graduate School of Education
Zip code 700-8530
Address 3-1-1 Tsushima-naka, Kita-ku, Okayama City, Okayama , Japan
TEL 086-251-7750
Email eisukeochi@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name Eisuke
Middle name
Last name Ochi
Organization Okayama University
Division name Graduate School of Education
Zip code 700-8530
Address 3-1-1 Tsushima-naka, Kita-ku, Okayama City, Okayama , Japan
TEL 086-251-7750
Homepage URL
Email eisukeochi@cc.okayama-u.ac.jp

Sponsor
Institute Okayama 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 Juntendo University
Address 1-1 Hiragagakuendai, Inzai, Chiba
Tel 0476-98-1001
Email ytsuchi@juntendo.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

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 14 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000021165
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5508798/
Number of participants that the trial has enrolled 21
Results 
Compared with the control group, M-wave latency was significantly shorter in the fish oil group immediately after exercise (p = 0.040), MVC torque was significantly higher at 1 day after exercise (p = 0.049), ROM was significantly greater at post and 2 days after exercise (post; p = 0.006, day 2; p = 0.014), and there was significantly less delayed onset muscle soreness at 1 and 2 days after exercise (day 1; p = 0.049, day 2; p = 0.023).
Results date posted
2020 Year 01 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
 Healthy men
Participant flow 
The subjects were randomly assigned to the fish oil group (n = 10) or control group (n = 11). The fish oil group consumed eight 300-mg EPA-rich fish oil softgel capsules (containing, in total, 600 mg EPA and 260 mg DHA) per day for 8 weeks before the exercise, and continued this for a further 5 days. The control group consumed an equivalent number of placebo capsules.
Adverse events 
Nothing
Outcome measures 
M-wave latency, MVC torque,  ROM, upper arm circumference, DOMS
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 07 Month 10 Day
Date of IRB
2015 Year 07 Month 10 Day
Anticipated trial start date
2015 Year 07 Month 18 Day
Last follow-up date
2015 Year 09 Month 23 Day
Date of closure to data entry
2015 Year 11 Month 20 Day
Date trial data considered complete
2015 Year 12 Month 30 Day
Date analysis concluded
2016 Year 01 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 13 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=R000021165