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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000033141
Receipt No. 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 2019/04/01

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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
Email 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
Email ochi@hosei.ac.jp

Sponsor
Institute Hosei University
Faculty of Bioscience and Applied Chemistry
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 Research Ethics Committee of Hosei University, Faculty of Bioscience and Applied Chemistry
Address 3-7-2 Kajino, Koganei, Tokyo
Tel 042-783-2732
Email 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://www.mdpi.com/journal/nutrients
Publication of results Published

Result
URL related to results and publications https://www.mdpi.com/journal/nutrients
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
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
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
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037799

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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