UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039197 |
|---|---|
| Receipt number | R000044700 |
| Scientific Title | Association of Peripheral White Blood Cell Count with Daily Fish Intake: Implication for the Anti-atherosclerotic Effect of Fish Consumption: A Cross-sectional Study |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2024/01/22 12:02:40 |
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Basic information
Public title
The relationship between fish consumption and cardiovascular risk
Acronym
Fish consumption and cardiovascular risk
Scientific Title
Association of Peripheral White Blood Cell Count with Daily Fish Intake: Implication for the Anti-atherosclerotic Effect of Fish Consumption: A Cross-sectional Study
Scientific Title:Acronym
Fish intake and WBC count
Region
| Japan |
Condition
Condition
Subjects undergoing a health check
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present cross-sectional study was aimed at analyzing the relationship between the mean weekly frequency of fish and WBC count
in apparently healthy individuals receiving health checkups.
Basic objectives2
Others
Basic objectives -Others
The present cross-sectional study was aimed at analyzing the relationship between
WBC count and serum lipid in healthy
individuals receiving health checkups.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary efficacy parameter was the relationship between the average weekly
frequency of fish intake and WBC count
Key secondary outcomes
The secondary endpoint was the relationship between WBC count and serum lipid profiles.
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 had
undergone their annual health checkups
between April 2018 and August 2018 at the
Health Planning Center of Nihon University Hospital
Key exclusion criteria
The following subjects were excluded from
this study: unwilling to provide consent
for participation in the study, current
intake of lipid-modifying therapy, positive history of ASCVD, malignant,
and TG level more than 400mg/dL.
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
Department of Health Planning Center, Nihon University Hospital
Institute
Department
Personal name
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
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 | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35650113/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35650113/
Number of participants that the trial has enrolled
1162
Results
https://pubmed.ncbi.nlm.nih.gov/35650113/
Results date posted
| 2023 | Year | 01 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://pubmed.ncbi.nlm.nih.gov/35650113/
Participant flow
https://pubmed.ncbi.nlm.nih.gov/35650113/
Adverse events
non
Outcome measures
https://pubmed.ncbi.nlm.nih.gov/35650113/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this cross-sectional study, we
investigate the association of the
frequency of fish intake (average number of days of fish intake per week) and the blood WBC count in apparently healthy
subjects in the Japanese population.
Among 4,768 Japanese subjects who had
undergone their annual health checkups
between April 2018 and August 2018 at the Health Planning Center of Nihon
University Hospital, 4,105 healthy
subjects were included this study. The
following subjects were excluded from
this study: unwilling to provide consent for participation in the study, current intake of lipid-modifying therapy,
positive history of ASCVD, malignant
neoplasm, inflammatory and allergic
disease, autoimmune disease, and subjects with a serum triglyceride level more than400mg/dL.
The primary efficacy parameter was the
relationship between the average weekly
frequency of fish intake and WBC count.
The secondary endpoint was the relationship between WBC count and serum
lipid profiles.
This study was conducted in accordance
with the ethical principles of the
Declaration of Helsinki. The study design and objective were approved by the Nihon University Hospital Ethics Committee and written informed consent was obtained
from all the study participants.
Management information
Registered date
| 2020 | Year | 01 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044700
