UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000061485
Receipt number R000070355
Scientific Title Analysis of the diet-gut microbiota correlation for preventing fatty deposition and fibrosis of the liver
Date of disclosure of the study information 2026/05/10
Last modified on 2026/05/08 09:07:11

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Basic information

Public title

Analysis of diet-gut microbiota correlation to prevent fatty deposits and fibrosis of the liver

Acronym

Prevention of fatty deposition and fibrosis of the liver

Scientific Title

Analysis of the diet-gut microbiota correlation for preventing fatty deposition and fibrosis of the liver

Scientific Title:Acronym

Preventive Hepatology

Region

Japan


Condition

Condition

metabolic dysfunction-associated steatotic liver disease: MASLD

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

An analysis of the diet-gut microbiota correlation to prevent hepatic fat deposition and fibrosis will be conducted on participants of the Kyotango Residents Cohort Study.

Basic objectives2

Others

Basic objectives -Others

Current Status of Alcohol Consumption Among Community-Dwelling Elderly Individuals

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Identification of Gut Microbiota-Diet Clusters Involved in the Prevention of Hepatic Fat Deposition and Fibrosis

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

People Able to Visit Hospitals

Key exclusion criteria

Individuals Undergoing Treatment for Serious Illnesses

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Yuji
Middle name
Last name Naito

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Human Immunology and Nutrition Science

Zip code

602-8566

Address

465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, Japan

TEL

075-251-5124

Email

ynaito@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Yuji
Middle name
Last name Naito

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Human Immunology and Nutrition Science

Zip code

602-8566

Address

465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, Japan

TEL

075-251-5124

Homepage URL


Email

ynaito@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of Medicine

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto Prefectural University of Medicine

Address

465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, Japan

Tel

075-251-5337

Email

rinri@koto.kpu-m.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

2026 Year 05 Month 10 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

Enrolling by invitation

Date of protocol fixation

2026 Year 05 Month 01 Day

Date of IRB

2015 Year 12 Month 01 Day

Anticipated trial start date

2026 Year 05 Month 01 Day

Last follow-up date

2030 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is an analysis of liver function in participants of the Kyotango Longevity Cohort, including intergroup comparisons.


Management information

Registered date

2026 Year 05 Month 08 Day

Last modified on

2026 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070355