UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054336 |
|---|---|
| Receipt number | R000062068 |
| Scientific Title | Study to verify the effect and feasibility of intervention with foods with high chewing frequency on oral function (pilot study) |
| Date of disclosure of the study information | 2024/05/08 |
| Last modified on | 2025/05/13 14:53:50 |
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Basic information
Public title
Oral and Eating Health Study
Acronym
Oral and Eating Health Study
Scientific Title
Study to verify the effect and feasibility of intervention with foods with high chewing frequency on oral function (pilot study)
Scientific Title:Acronym
Study to verify the effect and feasibility of intervention with foods with high chewing frequency on oral function (pilot study)
Region
| Japan |
Condition
Condition
oral hypofunction
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the effect on oral functions including masticatory ability by continuous intake of the food that are already commercially available and are considered to have a high number of chewing cycles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in indices related to oral function (number of corresponding items in the assessment of oral frailty or oral hypofunction) following 3 months of continuous consumption of sausage (Schauessen (NH Foods Ltd.)).
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Participants consume one or two pieces of sausage (Schauessen (NH Foods Ltd.)) per day, daily for 3 months.
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Persons who are 65 years of age or older at the time of participation in the study.
(2) Those who have received a full explanation about this study, and who have given their consent of their own free will based on a full understanding of the subject.
(3) Persons whose oral functions have deteriorated (Those who answered "yes" to the questions "Do you have any difficulty eating tough foods compared to 6 months ago?" or "Have you choked on your tea or soup recently?")
Key exclusion criteria
(1) Persons who are allergic to any of the foods used in the study.
(2) Persons who are currently participating in another study, within 4 weeks of the completion of the study, or are scheduled to participate in the next study.
(3) Persons who consume at least one rough sausage a day for at least 5 days a week.
(4) Persons who are unable to measure body composition by the impedance method due to a pacemaker, artificial arm, artificial leg, etc.
(5) Persons who do not take meals orally.
(6) Persons who are on a restricted diet as instructed by a doctor.
(7) Any other person who is deemed inappropriate as a participant by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Watanabe |
Organization
Hokkaido University
Division name
Gerodontology, Department of Oral Health Science, Faculty of Dental Medicine
Zip code
060-8586
Address
Nishi-7, Kita-13, Kita-ku, Sapporo, Hokkaido
TEL
011-706-4582
ywata@den.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhito |
| Middle name | |
| Last name | Miura |
Organization
Hokkaido University
Division name
Gerodontology, Department of Oral Health Science, Faculty of Dental Medicine
Zip code
060-8586
Address
Nishi-7, Kita-13, Kita-ku, Sapporo, Hokkaido
TEL
011-706-4582
Homepage URL
kmiura@den.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
NH Foods Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Research & Development Center, NH Foods Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Nishi-5, Kita-14, Kita-ku, Sapporo, Hokkaido
Tel
011-701-7636
crjimu@huhp.hokudai.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 | 05 | Month | 08 | 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
36
Results
32 participants were analyzed. When the number of applicable endpoints of oral hypofunction was defined as improved when it decreased after the intervention, unchanged when there was no change, and worsened when it increased, 22 (68.8%) participants were improved, 7 (21.9%) were unchanged, and 3 (9.4%) were worsened. In addition, Wilcoxon signed-rank test was performed on the number of applicable endpoints before and after the intervention, and a significant difference was found (P<0.001).
Results date posted
| 2025 | Year | 05 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
There are no adverse events.
Outcome measures
The number of applicable endpoints of oral hypofunction
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 05 | Month | 08 | Day |
Last modified on
| 2025 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062068
