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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039802
Receipt No. R000045394
Scientific Title Association of Fish Intake with the Serum Lipid in Apparently Healthy Subjects
Date of disclosure of the study information 2020/05/01
Last modified on 2020/06/05

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Basic information
Public title Relationship between fish intake, serum lipid, and lifestyle behaviors
Acronym Fish intake, serum lipid, and lifestyle behaviors
Scientific Title Association of Fish Intake with the Serum Lipid in Apparently Healthy Subjects
Scientific Title:Acronym Relationship between fish intake, serum lipid, and lifestyle behaviors
Region
Japan

Condition
Condition apparently healthy males visiting the Health Planning Center of Nihon University Hospital
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This cross-sectional study was conducted to investigate the association of the frequency of fish intake (average number of days of fish intake per week) and the serum lipid and lifestyle behaviors in apparently healthy males in the Japanese population.
Basic objectives2 Others
Basic objectives -Others none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate the association of the frequency of fish intake (average number of days of fish intake per week) and the serum L/H ratio 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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Subjects who had undergone their annual health checkups at Nihon University Hospital, Health Planning Center
Key exclusion criteria History of atherosclerotic cardiovascular disease
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
Address 1-6 Kandasurugadai, chiyodaku, Tokyo, 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, Japan
TEL 0332931711
Homepage URL
Email tani.shigemasa@nihon-u.ac.jp

Sponsor
Institute Nihon University Hospital, Health Planning Center
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 05 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 Open public recruiting
Date of protocol fixation
2020 Year 02 Month 01 Day
Date of IRB
2020 Year 04 Month 01 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation Study

Management information
Registered date
2020 Year 03 Month 13 Day
Last modified on
2020 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045394

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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