UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044148
Receipt number R000050379
Scientific Title Examination of simple intervention using genetic polymorphism information for excessive drinking
Date of disclosure of the study information 2021/06/01
Last modified on 2022/11/08 12:03:47

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Basic information

Public title

Examination of simple intervention using genetic constitution information of alcohol-metabolizing enzyme for excessive drinking

Acronym

Examination of intervention for excessive drinking constitutional information of alcohol-metabolizing enzymes

Scientific Title

Examination of simple intervention using genetic polymorphism information for excessive drinking

Scientific Title:Acronym

Examination of intervention using genetic polymorphism information for excessive drinking

Region

Japan


Condition

Condition

Excessive drinking that increases the risk of lifestyle-related diseases

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

We will study individual simple intervention methods by providing information on enzyme-active types of ALDH2 and ADH1B in young adults with excessive drinking, and verify their efficacy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Average amount of alcohol consumed per day when drinking

Key secondary outcomes

Stage of Change in drinking behavior, Health care and sleep and fatigue status


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Gene Behavior,custom

Interventions/Control_1

Intervention group:Intervention materials and notification of alcohol constitution test results

Interventions/Control_2

Control group:Alcohol Handbook (conventional teaching materials)

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

30 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Research participants at the University of Tsukuba (university students, graduate students, staff)

2. Drinkers who drink more than the average amount of alcohol per day increases the risk of lifestyle-related diseases (4 drinks for men = 40g of pure alcohol, 2 drinks for women = 20g of pure alcohol)

Key exclusion criteria

1. Those who do not want to know the result of the alcohol constitution test

2. Those who have difficulty communicating in Japanese

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Hisashi
Middle name
Last name Yoshimoto

Organization

University of Tsukuba

Division name

Faculty of medicine

Zip code

305-8575

Address

1-1-1 Tennodai, Tsukuba 305-8575

TEL

029-853-3101

Email

hisashiyoshi@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name Yukiko
Middle name
Last name Owaki

Organization

University of Tsukuba

Division name

Faculty of medicine

Zip code

305-8575

Address

1-1-1 Tennodai, Tsukuba 305-8575

TEL

029-853-3101

Homepage URL


Email

Oowaki.yuki@md.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba, Faculty of medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education,
Grants-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Sanwa Shurui Company, Sanwa Laboratory

Name of secondary funder(s)

Sanwa Shurui Company, Sanwa Laboratory


IRB Contact (For public release)

Organization

University of Tsukuba

Address

1-1-1 Tennodai, Tsukuba 305-8575

Tel

029-853-3022

Email

sien.ningenss@un.tsukuba.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

2021 Year 06 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


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

2021 Year 04 Month 25 Day

Date of IRB

2021 Year 04 Month 19 Day

Anticipated trial start date

2021 Year 06 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Protocol published.

https://pubmed.ncbi.nlm.nih.gov/36028843


Management information

Registered date

2021 Year 05 Month 09 Day

Last modified on

2022 Year 11 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050379


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name