UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041368 |
|---|---|
| Receipt number | 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 | 2023/02/11 10:59:41 |
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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
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
tani.shigemasa@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Hospital
Institute
Department
Personal name
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
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
https://www.journal-of-cardiology.com/article/S0914-5087(22)00156-3/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.journal-of-cardiology.com/article/S0914-5087(22)00156-3/fulltext
Number of participants that the trial has enrolled
6950
Results
https://www.journal-of-cardiology.com/article/S0914-5087(22)00156-3/fulltext
Results date posted
| 2023 | Year | 02 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://www.journal-of-cardiology.com/article/S0914-5087(22)00156-3/fulltext
Participant flow
https://www.journal-of-cardiology.com/article/S0914-5087(22)00156-3/fulltext
Adverse events
no
Outcome measures
https://www.journal-of-cardiology.com/article/S0914-5087(22)00156-3/fulltext
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2023 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047230
