UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025875 |
|---|---|
| Receipt number | 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 | 2022/07/31 22:00:17 |
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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 | 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
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
hidaka@int.osaka-sandai.ac.jp
Sponsor or person
Institute
Kansai Medical University Hospital
Health Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029715
