UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048829
Receipt number R000055641
Scientific Title Association of higher n-3 polyunsaturated fatty acids (N-3 PUFAs) consumption and lifestyle behaviors with a lower ratio of neutrophil-to-lymphocyte:
Date of disclosure of the study information 2022/09/02
Last modified on 2023/09/04 11:41:21

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Basic information

Public title

Relationship between n-3 PUFAs, lifestyle behaviors, and the ratio of neutrophil-to-lymphocyte

Acronym

Relationship between n-3PUFA, lifestyle behavior, and neutrophil/lymphocyte count

Scientific Title

Association of higher n-3 polyunsaturated fatty acids (N-3 PUFAs) consumption and lifestyle behaviors with a lower ratio of neutrophil-to-lymphocyte:

Scientific Title:Acronym

Association of higher N-3 PUFAs consumption and lifestyle behaviors with a lower ratio of neutrophil-to-lymphocyte:

Region

Japan


Condition

Condition

Atherosclerotic cardiovascular disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigated the association of n-3 PUFAs and lifestyle with NLR using cross-sectional methods

Basic objectives2

Others

Basic objectives -Others

The secondary endpoint was the association of n3-PUFAs consumption and lifestyle behaviors with NLR.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary endpoint was NLR according to the amount of n-3 PUFAs consumption.

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

18 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Japanese individuals who underwent annual health checkups between April 2019 and March 2020 at the Health Planning Center of Nihon University Hospital

Key exclusion criteria

The exclusion criteria were as follows: unwillingness to provide informed consent for participation; positive history of ASCVD; absence of data on the frequency of fish consumption and WBC subclass; current intake of lipid-modifying, antihypertensive, antidiabetic, or antihyperuricemic drugs.

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

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

101-0062

Address

Kandasurugadai 1-6, Chiyodaku

TEL

0332931711

Homepage URL


Email

tani.shigemasa@nihon-u.ac.jp


Sponsor or person

Institute

Nihon University Hospital

Institute

Department

Personal name



Funding Source

Organization

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 IRB

Address

Kandasurugadai1-6, Chiyodaku

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

2022 Year 09 Month 02 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/35835639/

Publication of results

Unpublished


Result

URL related to results and publications

J Cardiol . 2022 Jul 11;S0914-5087(22)00156-3. doi: 10.1016/j.jjcc.2022.06.010. Online ahead of prin

Number of participants that the trial has enrolled

6950

Results

A higher n-3 PUFA consumption and habitual aerobic exercise may be associated with a lower NLR. This association may partially explain the preventive effects of higher n-3 PUFAs consumption on CAD

Results date posted

2022 Year 09 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Among 11673 Japanese individuals who underwent annual health checkups between April 2019 and March 2020 at the Health Planning Center of Nihon University Hospital, 6950 were included in this study.

Participant flow

No

Adverse events

No

Outcome measures

The primary endpoint was NLR according to the amount of n-3 PUFAs consumption. The secondary endpoint was the association of n3-PUFAs consumption and lifestyle behaviors with NLR.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 04 Month 01 Day

Date of IRB

2020 Year 04 Month 09 Day

Anticipated trial start date

2019 Year 04 Month 01 Day

Last follow-up date

2020 Year 03 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Sross-setional study


Management information

Registered date

2022 Year 09 Month 02 Day

Last modified on

2023 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055641


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name