UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058094 |
|---|---|
| Receipt number | R000066396 |
| Scientific Title | A systematic review of the triglyceride-lowering effects of DHA/EPA in healthy individuals, including those with high triglyceride or LDL cholesterol(blood lipids) levels |
| Date of disclosure of the study information | 2025/06/09 |
| Last modified on | 2025/06/05 17:30:42 |
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Basic information
Public title
Triglyceride-lowering effect of DHA/EPA intake : Systematic Review
Acronym
Triglyceride-lowering effect of DHA/EPA : Systematic Review
Scientific Title
A systematic review of the triglyceride-lowering effects of DHA/EPA in healthy individuals, including those with high triglyceride or LDL cholesterol(blood lipids) levels
Scientific Title:Acronym
A systematic review of the triglyceride-lowering effects of DHA and EPA in healthy subjects
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aim to evaluate the triglyceride-lowering effects of sustained DHA/EPA intake in healthy adults, including individuals with borderline high blood lipid levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Triglyceride level
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Clinical trials under the following PICOS criteria:
P : Healthy adults, including those with mild dyslipidemia
I : Oral intake of foods containing DHA/EPA
C : Oral intake of placebo foods
O : Serum triglyceride levels
S : Randomized, placebo-controlled trials
2) Original articles published in peer-reviewed journals
Key exclusion criteria
1) trials include participants with serum triglyceride levels of 200 mg/dL or greater, or LDL cholesterol levels of 160 mg/dL or greater.
2) trials in which factors other than DHA/EPA intake may have influenced the outcomes
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Hagiuda |
Organization
Sankyo Co.,Ltd.
Division name
Scientific affairs Dept.
Zip code
417-0061
Address
3178-1 Denbo, Fuji-shi, Shizuoka
TEL
0545-54-1248
hagiuda-d@sankyocoltd.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Hagiuda |
Organization
Sankyo Co.,Ltd.
Division name
Scientific affairs Dept.
Zip code
417-0061
Address
3178-1 Denbo, Fuji-shi, Shizuoka
TEL
0545-54-1248
Homepage URL
hagiuda-d@sankyocoltd.co.jp
Sponsor or person
Institute
Sankyo Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Sankyo Co.,Ltd.
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
N/A
Address
N/A
Tel
0545-54-1248
hagiuda-d@sankyocoltd.co.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 09 | 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
| 2025 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1)This systematic research review will be conducted in accordance with PRISMA 2020.
2)A systematic literature search will be performed using following databases
-PubMed
-Ichushi-Web
-Cochrane Library
Management information
Registered date
| 2025 | Year | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066396
