UMIN-CTR Clinical Trial

Basic information
Public title	Study of connection between various masticatory indices according to phagodynamometer and lifestyle disease risk factors, and of mastication intervention effects
Acronym	Study of connection between various masticatory indices according to phagodynamometer and lifestyle disease risk factors, and of mastication intervention effects
Scientific Title	Study of connection between various masticatory indices according to phagodynamometer and lifestyle disease risk factors, and of mastication intervention effects
Scientific Title:Acronym	Study of connection between various masticatory indices according to phagodynamometer and lifestyle disease risk factors, and of mastication intervention effects
Region	Japan

Condition
Condition	1. metabolic syndrome 2. obesity 3. healthy subjects
Classification by specialty	Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Using a phagodynanometer to examine the connection between mastication frequency and other mastication-related indices and obesity-related factors (BMI, body composition, insulin resistance index), and then clarifying the connection between various masticatory indices and lifestyle disease risk factors.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Connection between mastication-related indices measured using a phagodynamometer and obesity-related factors, and the amount of change before and after dietary counseling intervention * Mastication-related indices: mastication frequency, mastication time (time to chew each piece of food), masticatory force (intensity of force when chewing)
Key secondary outcomes	1)BMI (Body Mass Index), 2)body composition (Dexa, INBody), 3)insulin resistance index, biochemical (serum) 4)arteriosclerotic index, 5)content of experimental food (cabbage, rice ball, doughnut), 6)experimental food order (1. cabbage, 2. rice ball, 3. doughnut), 7)cognitive function (cognitive function balancer: PC assignment for examining cognitive function), 8)personality characteristics (survey form for TEG, NEO, perfectionism, self-efficacy, social support, etc.), 9)Sakata eating habit questionnaire

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Mastication and dietary counseling intervention for 6 months for lifestyle disease patient.
Interventions/Control_2	Lifestyle disease patient(diet treatment only)
Interventions/Control_3	healthy volunteer(No treatment)
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	[Lifestyle disease patient] 1)Independent person 20 years or older at time of consent 2)Is receiving lifestyle disease counseling at health sciences center 3)Understands the tools, tests and other elements of this study, and is capable of using and implementing them 4)Has received a full explanation of participation in this study and given their written consent of their own accord [Healthy volunteer] 1)Independent person 20 years or older at time of consent 2)Understands the tools, tests and other elements of this study, and is capable of using and implementing them 3)Has received a full explanation of participation in this study from staff of the health sciences center or other relevant person, and given their written consent of their own accord
Key exclusion criteria	[Exclusion criteria] 1)Person having a mastication disorder due to cranial neuropathy or an oral disease 2)Has an otitis disorder 3)Has a mental illness which has been determined to make participation in the study difficult 4)Has otherwise been deemed unsuitable as a research subject by an investigator
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yutaka Middle name Last name Kimura
Organization	Kansai Medical University Hospital
Division name	Health Science
Zip code	573-1010
Address	2-5-1 Shin-machi, Hirakata City, Osaka 573-1010 Japan
TEL	072-804-0101
Email	kimuray@hirakata.kmu.ac.jp

Public contact
Name of contact person	1st name Nagisa Middle name Last name Hidaka
Organization	1)Osaka Sangyo University 2)Kansai Medical University Hospital
Division name	1)Faculty of Human Environment 2)Health Science
Zip code	574-8530
Address	3-1-1 Nakagaito, Daito City, Osaka 574-8530 Japan
TEL	072-875-3001
Homepage URL
Email	hidaka@int.osaka-sandai.ac.jp

Sponsor
Institute	Kansai Medical University Hospital Health Science
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kansai Medical University Hospital
Address	2-5-1 Shin-machi, Hirakata City, Osaka 573-1010 Japan
Tel	072-804-0101
Email	kimuray@hirakata.kmu.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	2017 Year 01 Month 27 Day

Related information
URL releasing protocol	https://www.mdpi.com/2072-6643/14/14/2990/review_report
Publication of results	Published

Result
URL related to results and publications	https://www.mdpi.com/2072-6643/14/14/2990/review_report
Number of participants that the trial has enrolled	87
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	2016 Year 12 Month 02 Day
Date of IRB	2016 Year 12 Month 02 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2021 Year 12 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 27 Day
Last modified on	2022 Year 07 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029715