UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042169
Receipt number R000048120
Scientific Title Systematic Review of The Inhibiion Effect of Intake of Eicosapentanoic acid and Docosahexaenoic acid on Level of Triglycerides
Date of disclosure of the study information 2020/11/01
Last modified on 2020/10/20 07:45:20

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Basic information

Public title

Systematic Review of The Inhibiion Effect of Intake of Eicosapentanoic acid and Docosahexaenoic acid on Level of Triglycerides

Acronym

SR of EPA and DHA on Level of Triglycerides

Scientific Title

Systematic Review of The Inhibiion Effect of Intake of Eicosapentanoic acid and Docosahexaenoic acid on Level of Triglycerides

Scientific Title:Acronym

SR of EPA and DHA on Level of Triglycerides

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the effect of intake of EPA and DHA on Level of Triglycereides in healghy adults.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Level of Triglycerides

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy adults

Key exclusion criteria

Sick Person, Pregnant

Target sample size



Research contact person

Name of lead principal investigator

1st name Mochida
Middle name
Last name Key

Organization

RCT Japan Co., Ltd.

Division name

R&D

Zip code

150-0002

Address

Shibuya-Hikarie 8F, 2-21-1, Shibuya, Shibuya-ku, Tokyo, Japan

TEL

03-3400-3200

Email

info@rctjapan.org


Public contact

Name of contact person

1st name Mochida
Middle name
Last name Key

Organization

RCT Japan Co., Ltd.

Division name

R&D

Zip code

150-0002

Address

Shibuya-Hikarie 8F, 2-21-1, Shibuya, Shibuya-ku, Tokyo, Japan

TEL

03-3400-3200

Homepage URL


Email

info@rctjapan.org


Sponsor or person

Institute

Kino-Ken Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

RCT Japan Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

RCT Japan Co., Ltd.

Address

Shibuya-Hikarie 8F, 2-21-1, Shibuya, Shibuya-ku, Tokyo, Japan

Tel

03-3400-3200

Email

info@rctjapan.org


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

2020 Year 11 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


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

Preinitiation

Date of protocol fixation

2020 Year 10 Month 19 Day

Date of IRB


Anticipated trial start date

2020 Year 10 Month 30 Day

Last follow-up date

2021 Year 11 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Key words
Eicosapentanoic acid, Docosahexaenoic acid,
Triglycerides


Management information

Registered date

2020 Year 10 Month 19 Day

Last modified on

2020 Year 10 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048120


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name