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

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 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

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://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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name