UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046557 |
|---|---|
| Receipt number | R000053119 |
| Scientific Title | Fish consumption may be associated with increased serum bilirubin leading to exerting an anti-inflammatory effect: anti-cardiovascular events of fish consumption |
| Date of disclosure of the study information | 2022/01/13 |
| Last modified on | 2023/09/15 11:01:33 |
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Basic information
Public title
Association between serum bilirubin, and inflammation
Acronym
Association between serum bilirubin, and inflammation
Scientific Title
Fish consumption may be associated with increased serum bilirubin leading to exerting an anti-inflammatory effect: anti-cardiovascular events of fish consumption
Scientific Title:Acronym
Association between fish consumption, serum bilirubin concentration, and anti-Inflammation
Region
| Japan |
Condition
Condition
Atherosclerotic cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to investigate the relationship between fish consumption in daily eating habits and serum TB concentration in health check-ups with no history of ASCVD, and to find the relationship between serum TB concentration and the serum CRP concentration and blood WBC count using a cross-sectional method.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was the relationship between the weekly amount of fish consumption and serum TB concentration.
Key secondary outcomes
The secondary endpoint is the relationship between serum TB concentration and inflammatory predictive markers of the development of ASCVD, i.e., white blood cell (WBC) count and serum C-reactive protein (CRP) concentration.
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 and Female
Key inclusion criteria
Japanese subjects who underwent their annual health checkups
Key exclusion criteria
Past medical history of ASCVD
No records of frequency of fish intake
Serum total bilirubin level more than 2.0 mg/dL
Inflammatory disease
Positive for HBs antigen
Positive for HCV antigen
Hepatic cirrhosis
Hepatocellular carcinoma
Metastatic liver cancer
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
Department of Health Planning Center
Zip code
101-8309
Address
1-6 Kandasurugadai, chiyodaku, Tokyo, Japan
TEL
81-3-3293-1711
tani.shigemasa@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigemasa |
| Middle name | |
| Last name | Tani |
Organization
Nihon University Hospital
Division name
Health Planning Center
Zip code
101
Address
1-6 Kandasurugadai, chiyodaku, Tokyo, Japan
TEL
0332931711
Homepage URL
tani.shigemasa@nihon-u.ac.jp
Sponsor or person
Institute
Department of Health Planning Center, Nihon University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Health Planning Center, Nihon 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, Tokyo, Japan
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
| 2022 | Year | 01 | Month | 13 | 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
| 2021 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 30 | 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 | 01 | Month | 06 | Day |
Last modified on
| 2023 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053119
