UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054056 |
|---|---|
| Receipt number | R000061701 |
| Scientific Title | Changes in grinding movement during chewing by physical properties, dosage, and form of food |
| Date of disclosure of the study information | 2024/04/05 |
| Last modified on | 2024/04/04 10:28:24 |
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Basic information
Public title
Changes in grinding movement during chewing by physical properties, dosage, and form of food
Acronym
Changes in grinding movement during chewing by physical properties, dosage, and form of food
Scientific Title
Changes in grinding movement during chewing by physical properties, dosage, and form of food
Scientific Title:Acronym
Changes in grinding movement during chewing by physical properties, dosage, and form of food
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effects of foods of varying physical properties and morphology on chewing trajectories.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Width of masticatory pathway
Key secondary outcomes
Angle of mouth opening and closing
Distance of mouth opening
Chewing speed
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
10
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test food1
Interventions/Control_2
Test food2
Interventions/Control_3
Test food3
Interventions/Control_4
Test food4
Interventions/Control_5
Test food5
Interventions/Control_6
Test food6
Interventions/Control_7
Test food7
Interventions/Control_8
Test food8
Interventions/Control_9
Test food9
Interventions/Control_10
Test food10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Those who can eat the test foods
(2) Those who have no dental symptoms and are not under dental treatment (periodic dental cleanings are acceptable)
(3) Those who have received sufficient explanation of the purpose and content of the study, have the ability to consent, have voluntarily volunteered to participate with a good understanding, and have agreed to participate in this study in writing
Key exclusion criteria
(1) Those who may develop allergies related to the study
(2) Those who are judged by the study representative to be inappropriate to participate in this study
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Takemasa |
Organization
Tokyo Denki University
Division name
School of science and engineering
Zip code
350-0394
Address
Ishizaka, Hatoyama-machi, Hiki-gun, Saitama
TEL
049-296-5969
takemasa@mail.dendai.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Kanno |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
Homepage URL
kanno_susumu@lotte.co.jp
Sponsor or person
Institute
Tokyo Denki University.
Institute
Department
Personal name
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
Tokyo Denki University
Address
5 Senju Asahi-cho, Adachi-ku, Tokyo
Tel
03-5284-5230
kenkyu-k@jim.dendai.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
| 2024 | Year | 04 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Separately, there are test foods 11-12 as interventions 11-22 and control food 1 as control 1, for a total of 23 groups.
Management information
Registered date
| 2024 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061701
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
