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

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 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

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 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name