UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Intake of EPA and DHA on Triglyceride: Systematic Review
Acronym	A Systematic Review of EPA and DHA
Scientific Title	Effects of Intake of EPA and DHA on Triglyceride: Systematic Review
Scientific Title:Acronym	A Systematic Review of EPA and DHA
Region	Japan

Condition
Condition	Healthy adults with normal or mildly high triglyceride
Classification by specialty	Not applicable 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 triglyceride.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Triglyceride
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy adults
Key exclusion criteria	People with metabolic syndrome pregnant wemen, and lactation
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Fumiyuki Middle name Last name Isami
Organization	Morinda Worldwide, Inc.
Division name	Product & Relations
Zip code	160-0023
Address	Morinda Bldg., 3-2-2 Nishisinjuku, Shinjuku-ku, Tokyo Japan
TEL	03-4330-8720
Email	Fumiyuki_Isami@jp.morinda.com

Public contact
Name of contact person	1st name Akemi Middle name Last name Uwaya
Organization	Morinda Worldwide, Inc.
Division name	Product & Relations
Zip code	160-0023
Address	Morinda Bldg., 3-2-2 Nishisinjuku, Shinjuku-ku, Tokyo Japan
TEL	03-4330-8720
Homepage URL
Email	Akemi_Uwaya@jp.morinda.com

Sponsor
Institute	Product & Relations, Morinda Worldwide, Inc.
Institute
Department

Funding Source
Organization	Product & Relations, Morinda Worldwide, Inc.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Morinda Worldwide Inc.
Address	Morinda Bldg., 3-2-2 Nishisinjuku, Shinjuku-ku, Tokyo Japan
Tel	03-4330-8740
Email	Tetsuya_Hosoya@jp.morinda.com

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	2018 Year 03 Month 20 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	Completed
Date of protocol fixation	2018 Year 03 Month 12 Day
Date of IRB	2019 Year 09 Month 12 Day
Anticipated trial start date	2018 Year 03 Month 20 Day
Last follow-up date	2019 Year 09 Month 12 Day
Date of closure to data entry	2019 Year 09 Month 12 Day
Date trial data considered complete	2019 Year 09 Month 12 Day
Date analysis concluded	2019 Year 09 Month 12 Day

Other

Other related information

Search Research papers, systematic reviews and clinical trial registrations are searched from 2 databases. Literature screening and data extraction Based on eligibility criteria, screening of literature and extraction of data are carried out independently by 2 reviewers. Bias risk assessment Bias risks are assessed independently by 2 reviewers. If there is any discrepancy in the assessment, it should be consulted and decided with another reviewer.

Management information
Registered date	2018 Year 03 Month 13 Day
Last modified on	2019 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036189