UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035899 |
|---|---|
| Receipt number | R000040901 |
| Scientific Title | Association of serum non-high-density lipoprotein cholesterol level with daily fish intake: implication for the anti-atherosclerotic effect of fish consumption |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2022/02/19 13:15:28 |
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Basic information
Public title
Association of serum non-high-density lipoprotein cholesterol level with daily fish intake: implication for the anti-atherosclerotic effect of fish consumption
Acronym
Fish intake and non-HDL-C
Scientific Title
Association of serum non-high-density lipoprotein cholesterol level with daily fish intake: implication for the anti-atherosclerotic effect of fish consumption
Scientific Title:Acronym
Fish intake and non-HDL-C
Region
| Japan |
Condition
Condition
apparently healthy subjects over the age of 50 with no history of lipid-modifying therapy or ASCVD, undergoing medical examinations at the Health Planning Center of Nihon University Hospital
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study was to explore the association of daily fish intake with serum non-HDL-C level in apparently healthy subjects using a cross-sectional study method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the relationship between daily fish consumption and serum non-HDL-C
level
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 and Female
Key inclusion criteria
over the age of 50 with no history of lipid-modifying therapy or ASCVD
Key exclusion criteria
under 50 years old, no history of lipid-modifying therapy or
ASCVD
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, Japan
TEL
09080537841
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 chiyoaku, Tokyo
TEL
09080537841
Homepage URL
tani.shigemasa@nihon-u.ac.jp
Sponsor or person
Institute
Department of Health Planning Center, Nihon University Hospital, Tokyo Japan
Institute
Department
Personal name
Funding Source
Organization
Japan Society of Health Evaluation and Promotion
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 Kanda-Surugadai, Chiyoda-ku
Tel
0332931711
ttanishigem@yahoo.co.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
| 2019 | Year | 03 | 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
Main results already published
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collecting data
Management information
Registered date
| 2019 | Year | 02 | Month | 17 | Day |
Last modified on
| 2022 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040901
