UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046012 |
|---|---|
| Receipt number | R000051761 |
| Scientific Title | Effects on blood fatty acid composition by continuous consumption of fish |
| Date of disclosure of the study information | 2021/11/09 |
| Last modified on | 2023/07/10 16:03:33 |
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Basic information
Public title
Effects on blood fatty acid composition by continuous consumption of fish
Acronym
Blood fatty acid composition by fish meal
Scientific Title
Effects on blood fatty acid composition by continuous consumption of fish
Scientific Title:Acronym
Blood fatty acid composition by fish meal
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine changes in blood fatty acids when eating fish.
Basic objectives2
Others
Basic objectives -Others
Examining the effects of the Japanese diet, which was mainly fish.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect of 2 weeks of fish consumption on blood fatty acid composition
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Fish meal
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy
Key exclusion criteria
Allergy to mackerel and salmon
Lactation and pregnancy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yukako |
| Middle name | |
| Last name | Hayashi |
Organization
Kyoto University
Division name
Graduate School of Agriculture
Zip code
611-0011
Address
Gokasho Uji
TEL
0774383750
hayashi.yukako.7s@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukako |
| Middle name | |
| Last name | Hayashi |
Organization
Kyoto University
Division name
Graduate School of Agriculture
Zip code
611-0011
Address
Gokasho Uji
TEL
0774383750
Homepage URL
hayashi.yukako.7s@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
ZENSHO HOLDINGS 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
Kyoto University
Address
Uji
Tel
0774383750
hayashi.yukako.7s@kyoto-u.ac.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
| 2021 | Year | 11 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
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
| 2021 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 09 | Day |
Last modified on
| 2023 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051761
