UMIN-CTR Clinical Trial
| Recruitment status | Main results already published |
| Unique ID issued by UMIN | UMIN000016149 |
| Receipt No. | R000018748 |
| Scientific Title | Influence of ingestion of eicosapentaenoic acid-rich fish oil on delayed onset muscle soreness following eccentric contractions |
| Date of disclosure of the study information | 2015/01/13 |
| Last modified on | 2020/01/11 (Ver. 9) |
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| Basic information | ||
| Public title | Influence of ingestion of eicosapentaenoic acid-rich fish oil on delayed onset muscle soreness following eccentric contractions | |
| Acronym | Influence of eicosapentaenoic acid on delayed onset muscle soreness | |
| Scientific Title | Influence of ingestion of eicosapentaenoic acid-rich fish oil on delayed onset muscle soreness following eccentric contractions | |
| Scientific Title:Acronym | Influence of eicosapentaenoic acid on delayed onset muscle soreness | |
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| Condition | |||
| Condition | Delayed onset muscle soreness | ||
| Classification by specialty |
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| Classification by malignancy | Others | ||
| Genomic information | NO | ||
| Objectives | |
| Narrative objectives1 | Fish oils mainly compose of polyunsaturated fatty acids including eicosapentaenoic acid (EPA). Because EPA is especially reported for high anti-inflammatory activity, EPA-rich fish oil may possess the effect on delayed onset muscle soreness (DOMS).
The purpose of this study is investigating the influence of EPA for DOMS following eccentric contractions. |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | Confirmatory |
| Trial characteristics_2 | Pragmatic |
| Developmental phase | Not applicable |
| Assessment | |
| Primary outcomes | I. After ingestion of tested materials for 8 weeks, subjects perform eccentric contraction with elbow flexors.
Before ECC, at 0, 1,2,3,5days after ECC 1. maximal isometric torque 2. range of motion 3. upper arm circumference 4. muscle soreness measured as a visual analog scale 5. blood test creatine kinase, myoglobin,IL-6, TNF-alpha II. work output of elbow flexors during ECC |
| Key secondary outcomes | Before and after ingestion of tested materials, weight, height and body fat percentage |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Parallel |
| Randomization | Randomized |
| Randomization unit | Individual |
| Blinding | Double blind -all involved are blinded |
| Control | Placebo |
| Stratification | NO |
| Dynamic allocation | NO |
| Institution consideration | Institution is considered as a block. |
| Blocking | NO |
| Concealment | No need to know |
| Intervention | ||
| No. of arms | 2 | |
| Purpose of intervention | Prevention | |
| Type of intervention |
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| Interventions/Control_1 | Tested material: EPA-rich fish oil
Dosage: 2.4g/day Duration: 8 weeks |
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| Interventions/Control_2 | Tested material: corn oil
Dosage: 2.4g/day Duration: 8 weeks |
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| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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/ regular consumption of other functional foods for muscle soreness/ 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 |
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| Target sample size | 24 | |||
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| Name of lead principal investigator |
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| Organization | Okayama University | ||||||
| Division name | Graduate School of Education | ||||||
| Zip code | 700-0082 | ||||||
| Address | 3-1-1 Tsushima-naka, Kita-ku, Okayama | ||||||
| TEL | 086-251-7750 | ||||||
| eisukeochi@cc.okayama-u.ac.jp | |||||||
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| Name of contact person |
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| Organization | Okayama University | ||||||
| Division name | Graduate School of Education | ||||||
| Zip code | 700-0082 | ||||||
| Address | 3-1-1 Tsushima-naka, Kita-ku, Okayama | ||||||
| TEL | 086-251-7750 | ||||||
| Homepage URL | |||||||
| 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 |
| 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 | |
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| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000018748 |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4875060/ | ||||||
| Number of participants that the trial has enrolled | 24 | ||||||
| Results | MVC was significantly higher in the EPA group than in the PL group at 2 - 5 days after exercise (p < 0.05). ROM was also significantly greater in the EPA group than in the PL group at 1 - 5 days after exercise (p < 0.05). At only 3 days after exercise, muscle soreness of the brachialis was significantly greater in the PL group than in the EPA group (p < 0.05), with a concomitant increase in serum IL-6 levels in the PL group. |
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| Results date posted |
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| Results Delayed | |||||||
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| Baseline Characteristics | Healthy men |
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| Participant flow | Twenty-four healthy men were randomly assigned to consume the EPA + DHA supplement (EPA, n = 12) or placebo (PL, n = 12) by the double-blind method. Participants consumed EPA + DHA or placebo supplement for 8 weeks prior to exercise and continued it until 5 days after exercise. |
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| Adverse events | Nothing |
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| Outcome measures | MVC torque, ROM, upper arm circumference, muscle soreness as well as serum creatine kinase, myoglobin, IL6, and TNF levels in blood |
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| Recruitment status | Main results already published | ||||||
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018748 |
