UMIN-CTR Clinical Trial

Basic information
Public title	The study of CHEWING ability in patients with LIFEstyle disease
Acronym	CHEWING-LIFE Study
Scientific Title	The study of CHEWING ability in patients with LIFEstyle disease
Scientific Title:Acronym	CHEWING-LIFE Study
Region	Japan

Condition
Condition	lifestyle disease
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal chewing ability of outpatients with lifestyle diseases in clinical practice
Basic objectives2	Others
Basic objectives -Others	investigation of actual conditions
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Prevalence of impaired masticatory performance in patients with lifestyle diseases evaluated by Gluco Sensor GS-II
Key secondary outcomes	1. Distribution of masticatory performance in patients with lifestyle diseases evaluated by Gluco Sensor GS-II 2. Distribution of masticatory performance in patients with lifestyle diseases evaluated by colour-changeable chewing gum 3. Prevalence and distribution of oral dryness in patients with lifestyle diseases 4. Prevalence of tongue and lip dysfunction and distribution of tongue and lip functions in patients with lifestyle diseases

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	Patients who meet all of the following criteria are included in this study. 1) Outpatients with lifestyle diseases (at least one of diabetes mellitus, dyslipidemia, hypertension, and hyperuricemia) in Shiraiwa Medical Clinic 2) male and female who are aged of 20 years or older when giving their consent 3) patients who provide written consent form to participate in this study after full explanation of the study
Key exclusion criteria	Patients who fall into any of the following criteria are excluded from participating in the study. 1) patients who need legal representatives 2) patients who are considered inappropriate to participate in this study by physicians
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Iichiro Middle name Last name Shimomura
Organization	Osaka University
Division name	Graduate School of Medicine, Department of Metabolic Medicine
Zip code	565-0871
Address	2-15 Yamadaoka, Suita-shi, Osaka
TEL	06-6879-5111
Email	shimomura@endmet.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Hiroki Middle name Last name Takayama
Organization	Soiken, Inc.
Division name	Clinical Study Support Division
Zip code	101-0052
Address	NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL	03-3295-1350
Homepage URL
Email	takayama@soiken.com

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	LOTTE Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Clinical Research Review Committee
Address	2-2 Yamadaoka, Suita-shi, Osaka
Tel	06-6210-8296
Email	rinri@hp-crc.osaka-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	2019 Year 09 Month 30 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	Completed
Date of protocol fixation	2019 Year 08 Month 07 Day
Date of IRB	2019 Year 09 Month 26 Day
Anticipated trial start date	2019 Year 11 Month 01 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study conducts masticatory function test by gluco sensor GS-II, masticatory function test by color-changeable chewing gum, oral dryness test, and tongue and lip function test in outpatients with lifestyle diseases.

Management information
Registered date	2019 Year 08 Month 29 Day
Last modified on	2021 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043150