UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031702 |
|---|---|
| Receipt number | R000036189 |
| Scientific Title | Effects of Intake of EPA and DHA on Triglyceride: Systematic Review |
| Date of disclosure of the study information | 2018/03/20 |
| Last modified on | 2019/09/12 11:39:32 |
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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
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
Akemi_Uwaya@jp.morinda.com
Sponsor or person
Institute
Product & Relations, Morinda Worldwide, Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036189
