UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033141 |
|---|---|
| Receipt number | R000037799 |
| Scientific Title | Influence of ingestion of eicosapentaenoic acid-rich fish oil on muscular endurance and vascular endothelial function : a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2018/06/28 |
| Last modified on | 2020/01/11 04:31:11 |
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Basic information
Public title
Influence of ingestion of eicosapentaenoic acid-rich fish oil on muscular endurance and vascular endothelial function : a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym
Influence of eicosapentaenoic acid on muscular endurance and vascular endothelial function
Scientific Title
Influence of ingestion of eicosapentaenoic acid-rich fish oil on muscular endurance and vascular endothelial function : a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
Influence of eicosapentaenoic acid on muscular endurance and vascular endothelial function
Region
| Japan |
Condition
Condition
vascular endothelial function
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the influence of eicosapentaenoic acid for vascular endothelial function and muscular endurance performance after exercise
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, we will measure the flow-mediated dilatation before and after exercise
Key secondary outcomes
1) maximal isometric torque
2) RPE
3) oxygen saturation in skeletal muscle
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
| 18 | 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
24
Research contact person
Name of lead principal investigator
| 1st name | Eisuke |
| Middle name | |
| Last name | Ochi |
Organization
Hosei University
Division name
Faculty of Bioscience and Applied Chemistry
Zip code
184-8584
Address
3-7-2 Kajino, Koganei, Tokyo
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 and Applied Chemistry
Zip code
184-8584
Address
3-7-2 Kajino, Koganei, Tokyo
TEL
042-387-6337
Homepage URL
ochi@hosei.ac.jp
Sponsor or person
Institute
Hosei University
Faculty of Bioscience and Applied Chemistry
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, Faculty of Bioscience and Applied Chemistry
Address
3-7-2 Kajino, Koganei, Tokyo
Tel
042-783-2732
tamatai@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
| 2018 | Year | 06 | Month | 28 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000037799
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/31671276
Number of participants that the trial has enrolled
19
Results
Subjects in both groups reached exhaustion after the muscular endurance test, while the maximal repetitions did not differ between the groups. Similarly, there is no significant difference in the oxygen saturation in muscle tissue (StO2), an index of muscle oxygen availability, between the groups. Also, MVC and blood lactate did not change between groups.
Results date posted
| 2019 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 01 | Month | 02 | Day |
Baseline Characteristics
healthy men
Participant flow
Nineteen healthy men were randomly assigned to a placebo group or EPA+DHA group in a double-blind fashion. The EPA+DHA group was administered EPA-rich fish oil, containing 600 mg EPA and 260 mg DHA per day for 8 weeks. The placebo group received matching capsules for the same duration of time.
Adverse events
Nothing
Outcome measures
Repetitions, MVC, FMD, StO2
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 25 | 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=R000037799
