UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016149 |
|---|---|
| Receipt number | 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 04:33:20 |
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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
Region
| Japan |
Condition
Condition
Delayed onset muscle soreness
Classification by specialty
| Not applicable | Adult |
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
| 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
| 30 | years-old | > |
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
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
700-0082
Address
3-1-1 Tsushima-naka, Kita-ku, Okayama
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
700-0082
Address
3-1-1 Tsushima-naka, Kita-ku, Okayama
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 | 01 | Month | 13 | Day |
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.
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
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.
Adverse events
Nothing
Outcome measures
MVC torque, ROM, upper arm circumference, muscle soreness as well as serum creatine kinase, myoglobin, IL6, and TNF levels in blood
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 07 | 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=R000018748
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| Registered date | File name |
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