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UMIN ID:

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

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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
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 700-0082
Address 3-1-1 Tsushima-naka, Kita-ku, Okayama
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018748

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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