UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018285 |
|---|---|
| Receipt number | 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 05:17:22 |
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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
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
eisukeochi@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama 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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
1-1 Hiragagakuendai, Inzai, Chiba
Tel
0476-98-1001
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021165
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