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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041368
Receipt No. R000047230
Scientific Title The Associations with Frequency of Fish Intake with Monocyte/high-density Lipoprotein Cholesterol Ratio and Lifestyle Behaviors in Japanese Males over 50 years of age: A Possible Mechanism of Anti-atherosclerotic Effect of Fish Consumption
Date of disclosure of the study information 2020/08/10
Last modified on 2021/01/19

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Basic information
Public title The Associations with Frequency of Fish Intake with Monocyte/high-density Lipoprotein Cholesterol Ratio and Lifestyle Behaviors in Japanese Males over 50 Years of Age
Acronym Fish intake, monocyte /HDL-C ratio, and Lifestyle Behaviors
Scientific Title The Associations with Frequency of Fish Intake with Monocyte/high-density Lipoprotein Cholesterol Ratio and Lifestyle Behaviors in Japanese Males over 50 years of age: A Possible Mechanism of Anti-atherosclerotic Effect of Fish Consumption
Scientific Title:Acronym Fish intake and monocyte /HDL-C ratio
Region
Japan

Condition
Condition Japanese males over 50 years of age, who had undergone their annual health checkups
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the present cross-sectional study was to investigate the relationship between the average number of days of fish intake per week and the MHR and lifestyle behaviors, in males over 50 years of age.
Basic objectives2 Others
Basic objectives -Others And furthermore, to explore risk stratification of ASCVD with the combined MHR with serum HDL-C level
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint was the associations of the average weekly frequency of fish intake with MHR and lifestyle behaviors.
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
50 years-old <=
Age-upper limit
80 years-old >
Gender Male
Key inclusion criteria Males over 50 years of age receiving an annual health check
Key exclusion criteria refusal to provide consent for participation in the study, female subjects, current intake of lipid-modifying therapy, which has a remodeling effect on the serum HDL-C, positive history of ASCVD, triglyceride level over 400mg/dL, no measurement of WBC subclass, and absence of a record of the weekly frequency of fish intake.
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 101-8309, Japan
TEL 0332931711
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 101-8309
Address 1-6 kandasurugadai, chiyodaku, Tokyo 101-8309, Japan
TEL 0332931711
Homepage URL
Email tani.shigemasa@nihon-u.ac.jp

Sponsor
Institute Nihon University Hospital
Institute
Department

Funding Source
Organization Nihon University Hospital, Health Planning Center
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 101-8309, 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
2020 Year 08 Month 10 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
2020 Year 04 Month 01 Day
Date of IRB
2020 Year 04 Month 15 Day
Anticipated trial start date
2020 Year 08 Month 10 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cross-sectional study

Management information
Registered date
2020 Year 08 Month 10 Day
Last modified on
2021 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047230

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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