UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060107 |
|---|---|
| Receipt number | R000068749 |
| Scientific Title | Study on Improving Articulation Through Oral Training |
| Date of disclosure of the study information | 2025/12/19 |
| Last modified on | 2025/12/17 17:57:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on Improving Articulation Through Oral Training
Acronym
Study on Improving Articulation Through Oral Training
Scientific Title
Study on Improving Articulation Through Oral Training
Scientific Title:Acronym
Study on Improving Articulation Through Oral Training
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study on Improving Articulation Through Oral Training
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Oral diadochokinesis(pa,ta,ka)
Key secondary outcomes
Masticatory function, bite force, tongue pressure, lip closure force
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
No need to know
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Maneuver |
Interventions/Control_1
Non-intervention group
Interventions/Control_2
Tongue Training group
Interventions/Control_3
Food training group
Interventions/Control_4
Voice Training group
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Subjects giving written informed consent
(2) Subjects who enjoy eating test food
Key exclusion criteria
(1) Subjects with symptoms that may affect test food intake
(2) Subjects currently undergoing dental treatment, including orthodontic treatment (excluding routine cleanings)
(3) Subjects taking medications that may potentially affect the results
(4) Subjects planning to become pregnant or breastfeed during the trial period
(5) Subjects at risk of developing allergies related to the trial
(6) Subjects deemed unsuitable for participation in this trial by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Okabayashi |
Organization
Lotte Co., Ltd.
Division name
Research and Development Center, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
okabayashi_kazuto@lotte.co.jp
Public contact
Name of contact person
| 1st name | Kazuto |
| Middle name | |
| Last name | Okabayash |
Organization
Lotte Co., Ltd.
Division name
Research and Development Center, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
Homepage URL
okabayashi_kazuto@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
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
Shiba Palace Clinic
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1590
jimukyoku@mail.souken-r.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 19 | 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
| 2025 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068749
