UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046852 |
|---|---|
| Receipt number | R000053456 |
| Scientific Title | The study to verify the level of "Kamigotae". -A comparison between ratio of gummy's textural properties and ratio of masseter muscle's total muscle activity- |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2022/12/14 12:28:54 |
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Basic information
Public title
The study to verify the level of "Kamigotae".
-A comparison between ratio of gummy's textural properties and ratio of masseter muscle's total muscle activity-
Acronym
The study to verify the level of "Kamigotae".
Scientific Title
The study to verify the level of "Kamigotae".
-A comparison between ratio of gummy's textural properties and ratio of masseter muscle's total muscle activity-
Scientific Title:Acronym
The study to verify the level of "Kamigotae".
Region
| Japan |
Condition
Condition
Healthy adult (range in age from 20 to 50s)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify correlation between ratios of gummy's textural properties and ratios of masseter muscle's total muscle activity. Gummy's textural properties will be measured by specific measuring equipment. Masseter muscle's total muscle activity will be measured by surface electrode.
Basic objectives2
Others
Basic objectives -Others
To verify correlation between ratios of masseter muscle's total muscle activity when chewing different types of gummies.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A comparison between ratio of gummy's textural properties that measured by specific measuring equipment and masseter muscle's total muscle activity that measured by surface electromyograohy (EMG) of masseter.
Key secondary outcomes
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
4 kinds of gummies, 12 pieces 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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Volunteers from employees of Meiji co., Ltd.
2.Healthy adults range in age from 20 to 50s at the time of informed consent.
3.Subjects who agree to participate in this study with a written informend consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1.Subjects who have gelatin, apple or dairy product allergy.
2.Subjects who take medicines that may reduce saliva secretion often.
3. Subjects with missing teeth other than third molars (wisdom teeth).
4.Subjects who feel uncomfortable with mastication.
5.Subjects who has teeth under treatment.
6.Subjects who does not like samples.
7.Subjects who get involved in this research project and might be biased to results.
8.Subjects who are judged unsuitable for this study by the principal investigator.
Target sample size
10
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 | Reina |
| Middle name | |
| Last name | Kanda |
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
reina.kanda@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 clinical review committee
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
| 2022 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://www.meiji.co.jp/corporate/pressrelease/2022/1006_01/index.html
Number of participants that the trial has enrolled
10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 04 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 04 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 07 | Day |
Last modified on
| 2022 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053456
