UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053972 |
|---|---|
| Receipt number | R000059956 |
| Scientific Title | Verification of the relationship between fish intake and body composition and health indicators |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/09/20 10:41:26 |
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Basic information
Public title
Verification of the relationship between fish intake and body composition and health indicators
Acronym
Verification of the relationship between fish intake and body composition and health indicators
Scientific Title
Verification of the relationship between fish intake and body composition and health indicators
Scientific Title:Acronym
Verification of the relationship between fish intake and body composition and health indicators
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The health benefits of fish are clear, as there are many reports of fish oil's effectiveness in reducing the risk of cardiac disease and improving cognitive performance, among a wide range of other benefits, but the guidelines for fish consumption are not explicitly stated. In addition, although fish is an important source of protein for Japanese people, there are not many reports on its usefulness. In order to clarify the relationship between fish-derived protein intake and health indicators among Japanese, this study will examine the relationship between fish intake and body composition and health-related indicators among the registered users of the health application "Asuken.
Translated with www.DeepL.com/Translator (free version)
Basic objectives2
Others
Basic objectives -Others
NONE
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Lifestyle habits related to fish intake
Key secondary outcomes
Base
Study type
Observational
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
From the dietary data registered in "Asken," a total of 1,800 men and women, 300 low, 300 medium, and 300 high fish intakes on a daily basis, will be selected.
Key exclusion criteria
NONE
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Tahara |
Organization
Hiroshima University
Division name
Department of Public Health and Health Policy
Zip code
734-0037
Address
Kasumi 1-2-3, Hiroshima-shi, Hiroshima
TEL
07026426103
yutahara@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Tahara |
Organization
Hiroshima University
Division name
Department of Public Health and Health Policy
Zip code
734-0037
Address
Kasumi 1-2-3, Hiroshima-shi, Hiroshima
TEL
07026426103
Homepage URL
yutahara@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Yu Tahara
Funding Source
Organization
Nissui Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University
Address
Kasumi 1-2-3, Hiroshima-shi, Hiroshima
Tel
082-257-5907
iryo-sinsa@office.hiroshima-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
| 2026 | Year | 04 | Month | 01 | 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
| 2023 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | 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
Online survey
Management information
Registered date
| 2024 | Year | 03 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059956
