UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030351
Receipt number R000034650
Scientific Title Analytical protocol of Iwaki Health Promotion Project-Analyses with focus on visceral fat
Date of disclosure of the study information 2018/01/01
Last modified on 2020/06/17 12:20:25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Analytical protocol of Iwaki Health Promotion Project-Analyses with focus on visceral fat

Acronym

Analytical protocol of Iwaki Health Promotion Project

Scientific Title

Analytical protocol of Iwaki Health Promotion Project-Analyses with focus on visceral fat

Scientific Title:Acronym

Analytical protocol of Iwaki Health Promotion Project

Region

Japan


Condition

Condition

Visceral obesity

Classification by specialty

Medicine in general Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate an associated factor on visceral fat, we analyse with focus on oral and intestinal flora, and on nervous system such as cognitive, visual and auditory functions

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Association between visceral fat accumulation and the other factors (Health check data was obtained from community resident annually from 2015 to 2017)

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Japanese men and women at age of 20 and more living in Iwaki area of Hirosaki city, Aomori Pref.

Key exclusion criteria

none

Target sample size

600


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigeyuki Nakaji

Organization

Hirosaki University

Division name

Department of Social Medicine, School of Medicine

Zip code


Address

5 Zaifu-cho Hirosaki, Aomori 036-8562, Japan

TEL

0172-39-5041

Email

nakaji@hirosaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mitsuhiro Katashima

Organization

Hirosaki University

Division name

Department of Active Life Promotion, School of Medicine

Zip code


Address

5 Zaifu-cho Hirosaki, Aomori 036-8562, Japan

TEL

0172-39-5478

Homepage URL


Email

katashima.mitsuhiro@kao.co.jp


Sponsor or person

Institute

Department of Active Life Promotion, School of Medicine, Hirosaki University

Institute

Department

Personal name



Funding Source

Organization

Hirosaki city, Aomori pref.

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Kao Corporation

Name of secondary funder(s)

Kao Corporation


IRB Contact (For public release)

Organization


Address


Tel


Email



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

弘前大学医学部社会医学講座


Other administrative information

Date of disclosure of the study information

2018 Year 01 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

1000

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

No longer recruiting

Date of protocol fixation

2015 Year 04 Month 22 Day

Date of IRB


Anticipated trial start date

2015 Year 05 Month 30 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Investigation with focus on visceral fat using the health check data obtained from Japanese
adult men and women living around Iwaki area of Hirosaki city, Aomori Pref since 2015.


Management information

Registered date

2017 Year 12 Month 11 Day

Last modified on

2020 Year 06 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034650


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name