UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049861 |
|---|---|
| Receipt number | R000056790 |
| Scientific Title | The effect of ingestion of eicosapentaenoic acid and Docosahexaenoic acid on sleep - A systematic review |
| Date of disclosure of the study information | 2023/12/20 |
| Last modified on | 2024/06/21 13:59:04 |
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Basic information
Public title
The effect of ingestion of eicosapentaenoic acid and Docosahexaenoic acid on sleep - A systematic review
Acronym
Effect of DHA and EPA on sleep - A systematic review
Scientific Title
The effect of ingestion of eicosapentaenoic acid and Docosahexaenoic acid on sleep - A systematic review
Scientific Title:Acronym
Effect of DHA and EPA on sleep - A systematic review
Region
| Japan |
Condition
Condition
Healthy adult
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 effect of ingestion of DHA and EPA on sleep.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep assessment
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
Healthy adults
Key exclusion criteria
Participants who are suffering from illness, children (persons under 18 years) and pregnant
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Norikazu |
| Middle name | |
| Last name | Watanabe |
Organization
Yakujihou Marketing Jimusho Inc.
Division name
none
Zip code
100-8962
Address
Nagatacho 2-11-1, Chiyoda-ku, Tokyo
TEL
03-6205-3546
watanabe@yakujihou-marketing.co.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Yanagimoto |
Organization
Nissui Corporation
Division name
Food function R&D center
Zip code
105-8676
Address
Nishishinbashi 1-3-1, Minato-ku, Tokyo
TEL
08020982093
Homepage URL
yanagimoto@nissui.co.jp
Sponsor or person
Institute
Nissui Corporation.
Institute
Department
Personal name
Funding Source
Organization
Nissui Corporation
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
not applicable
Address
not applicable
Tel
0000
0000
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
| 2023 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 12 | Month | 21 | Day |
Last modified on
| 2024 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056790
