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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025875
Receipt No. R000029715
Scientific Title Study of connection between various masticatory indices according to phagodynamometer and lifestyle disease risk factors, and of mastication intervention effects
Date of disclosure of the study information 2017/01/27
Last modified on 2019/01/29

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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
Middle name
Last name Yutaka Kimura
Organization Kansai Medical University Hospital
Division name Health Science
Zip code
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
Middle name
Last name Nagisa Hidaka
Organization 1)Osaka Sangyo University 2)Kansai Medical University Hospital
Division name 1)Faculty of Human Environment 2)Health Science
Zip code
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 27 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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
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
2019 Year 01 Month 29 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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