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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046557
Receipt No. 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 2022/02/01

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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
Email 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
Email tani.shigemasa@nihon-u.ac.jp

Sponsor
Institute Department of Health Planning Center, Nihon University Hospital
Institute
Department

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
Email 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 Open public recruiting
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
2022 Year 02 Month 01 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053119

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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