UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024956 |
|---|---|
| Receipt number | R000028714 |
| Scientific Title | Influence of ingestion of eicosapentaenoic acid-rich fish oil on muscle fatigue : a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2016/11/27 |
| Last modified on | 2020/01/11 05:30:19 |
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Basic information
Public title
Influence of ingestion of eicosapentaenoic acid-rich fish oil on muscle fatigue : a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym
Influence of eicosapentaenoic acid on muscle fatigue
Scientific Title
Influence of ingestion of eicosapentaenoic acid-rich fish oil on muscle fatigue : a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
Influence of eicosapentaenoic acid on muscle fatigue
Region
| Japan |
Condition
Condition
muscle fatigue
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 for muscle fatigue following resistance training
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
After ingestion of tested materials for 8 weeks, subjects perform resistance training with elbow flexors. Before and after resistance training,
1) maximal isometric contraction torque
2) range of motion
3) magnetic resonance imaging analysis for elbow flexors
4) muscle fatigue measured as a visual analog scale
Key secondary outcomes
After ingestion of tested materials for 8 weeks, subjects perform resistance training with elbow flexors. Before and after resistance training, derivatives of reactive oxygen metabolites (d-ROMs) and biological antioxidant potential (BAP) in blood
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
/resistance training more than five times a week for a year /no resistance training or exercise during over a year /serious liver, kidney, heart, respiratory, endocrine or metabolic diseases/ scheduled for surgery during this study/ administration of regular medication/ regular administration of supplements which affect this study / food allergies/ 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
20
Research contact person
Name of lead principal investigator
| 1st name | Eisuke |
| Middle name | |
| Last name | Ochi |
Organization
Hosei University
Division name
Faculty of Bioscience
Zip code
184-8684
Address
3-7-2 Kajino-cho, Koganei, Tokyo, Japan
TEL
042-387-6337
ochi@hosei.ac.jp
Public contact
Name of contact person
| 1st name | Eisuke |
| Middle name | |
| Last name | Ochi |
Organization
Hosei University
Division name
Faculty of Bioscience
Zip code
184-8684
Address
3-7-2 Kajino-cho, Koganei, Tokyo, Japan
TEL
042-387-6337
Homepage URL
ochi@hosei.ac.jp
Sponsor or person
Institute
Hosei 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
Research Ethics Committee of Hosei University Sports Research Center
Address
Aihara-cho, Machida, Tokyo, Japan
Tel
042-783-2732
yhayash@hosei.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
法政大学生命科学部（東京都）
（Hosei Univesity Faculty of Bioscience）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 27 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000028714
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30260740
Number of participants that the trial has enrolled
16
Results
The work output during CONs in the EPA group was greater than that in the placebo group at the fifth set. In addition, ROM in the EPA group was significantly greater than that in the placebo group immediately after exercise. The increase of CSA in the EPA group was significantly smaller than that in the placebo group immediately after exercise.
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
Subjects were randomly administered with EPA and DHA supplement or placebo by a double-blind method. The EPA group was administered EPA-rich fish oil, containing 600mg EPA and 260mg DHA per day for 8 weeks. The subjects performed 5 sets of 6 maximal CONs of elbow flexors. The work output and peak torque were assessed during exercise.
Adverse events
Nothing
Outcome measures
The work output, peak torque, MVC, ROM, upper arm circumference, muscle fatigue CSA, La
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 27 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 22 | 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=R000028714
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