UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052084 |
|---|---|
| Receipt number | R000059445 |
| Scientific Title | The effect of difference in food categories on masticatory pattern. |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/03/07 19:56:03 |
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Basic information
Public title
The effect of difference in food categories on masticatory pattern.
Acronym
The effect of difference in food categories on masticatory pattern.
Scientific Title
The effect of difference in food categories on masticatory pattern.
Scientific Title:Acronym
The effect of difference in food categories on masticatory pattern.
Region
| Japan |
Condition
Condition
Adult (range in age from 21 to 59)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of different food categories on mastication patterns is verified using surface electromyography data of mastication-related muscles.
Basic objectives2
Others
Basic objectives -Others
Surface electromyography data of mastication-related muscles when chewing foods of different food classifications is used for analysis.
Multiple features are extracted from surface electromyography data, patterned, and cluster analyzed to evaluate differences and similarities between foods.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Surface electromyography data of mastication-related muscles
Key secondary outcomes
Compare surface electromyography data with maximum bite force, sensory evaluation during mastication, and measured values from a mastication simulator.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
9 kinds of general foods, 18 items for total + water
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
| 21 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Volunteers of employees.
2. Adults between the ages of 21 and 59 at the time of informed consent.
3. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1. Subjects who have food allergies to gelatin, milk, wheat, beef, soybeans, pork, or squid.
2. Subjects who take medicines that may reduce saliva secretion daily .
3. Subjects with missing teeth other than third molars (wisdom teeth).
4. Subjects who feel uncomfortable with mastication.
5. Subjects who have a diagnosis of bite abnormality.
6. Subjects who have teeth under treatment.
7. Subjects who do not like samples.
8. Subjects who get involved in this research project and might be biased to results.
9. Subjects who are judged unsuitable for this study by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Toyama |
Organization
Meiji Co., Ltd
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL
042-632-5824
yoshio.toyama@meiji.com
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Kubota |
Organization
Meiji Co., Ltd
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL
042-632-5824
Homepage URL
takayuki.kubota@meiji.com
Sponsor or person
Institute
R&D Division of Meiji Co., Ltd
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
Tel
042-632-5900
MEIJI.IRB@meiji.com
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
株式会社 明治 イノベーションセンター（東京都）
（Meiji Co., Ltd Meiji Innovation center (Tokyo)）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | 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
30
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
| 2023 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059445
