UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043206 |
|---|---|
| Receipt number | R000049313 |
| Scientific Title | Associations between Fish Intake, Chronic inflammation, and Sleep Duration of Japanese Men aged over 40 Years: A Possible Mechanism of the Anti-atherosclerotic Effect of Fish Consumption |
| Date of disclosure of the study information | 2021/02/03 |
| Last modified on | 2023/02/03 11:07:07 |
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Basic information
Public title
Relationship between fish intake, chronic inflammation, and sleep duration
Acronym
Relationship between fish intake, chronic inflammation, and sleep duration
Scientific Title
Associations between Fish Intake, Chronic inflammation, and Sleep Duration of Japanese Men aged over 40 Years: A Possible Mechanism of the Anti-atherosclerotic Effect of Fish Consumption
Scientific Title:Acronym
Fish intake, WBC count, and sleep duration
Region
| Japan |
Condition
Condition
Individuals receiving an annual health check
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This cross-sectional study investigated the association between the frequency of fish intake, and blood WBC count on sleep duration in healthy men aged over 40 years without receiving medical drug treatments or no history of ASCVD.
Basic objectives2
Others
Basic objectives -Others
Non
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the association between the weekly frequency of fish intake (average number of days of fish intake per week), sleep duration, and the peripheral blood WBC cell count in Japanese men over 40 years of age.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
Among 11379 healthy Japanese participants who had undergone their annual health checkups between April 2018 and March 2019 at the Health Planning Center of Nihon University Hospital
Key exclusion criteria
The exclusion criteria included refusal to provide consent for participation in the study, women participants, current intake of lipid-modifying therapy, antidiabetic therapy, antihypertensive therapy, or antihyperuricemic therapy, positive history of ASCVD, no measurement of WBC count, and absence of a record of the weekly frequency of fish intake and sleep duration.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Shigemasa |
| Middle name | |
| Last name | Tani |
Organization
Nihon University Hospital
Division name
Health Planning Center
Zip code
101-8309
Address
1-6 kandasurugadai,chiyodaku, Tokyo
TEL
0332931711
tani.shigemasa@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigemasa |
| Middle name | Takahashi |
| Last name | Tani |
Organization
Nihon University Hospital
Division name
Health Planning Center
Zip code
101-8309
Address
1-6 Kandasurugadai, chiyodaku
TEL
0332931711
Homepage URL
takahashi.atsuhiko@nihon-u.ac.jp
Sponsor or person
Institute
Department of Health Planning Center
Institute
Department
Personal name
Funding Source
Organization
Department Nihon UniversityNihon University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Hospital IRB
Address
1-6 Kandasurugadai, chiyodaku
Tel
0332931711
tani.shigemasa@nihon-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 | 02 | Month | 03 | 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
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design and Study Populations
We conducted a cross-sectional study to investigate the association between the weekly frequency of fish intake (average number of days of fish intake per week), sleep duration, and the peripheral blood WBC cell count in Japanese men over 40 years of age. Among 11379 healthy Japanese participants who had undergone their annual health checkups between April 2018 and March 2019 at the Health Planning Center of Nihon University Hospital, we recruited 3899 men for this study.
This study was conducted following the ethical principles of the Declaration of Helsinki. The Nihon University Hospital Ethics Committee approved the study design and objective (approved number: 20200405) and written informed consent was obtained from the study participants.
Management information
Registered date
| 2021 | Year | 02 | Month | 01 | Day |
Last modified on
| 2023 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049313
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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