UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050862 |
|---|---|
| Receipt number | R000057965 |
| Scientific Title | Evaluation of the Effectiveness of Nutritional Guidance for Preventing the Development of Oral Frailty |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2025/10/18 22:01:54 |
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Basic information
Public title
Evaluation of the Effectiveness of Nutritional Guidance for Preventing the Development of Oral Frailty
Acronym
Evaluation of the Effectiveness of Nutritional Guidance for Preventing the Development of Oral Frailty
Scientific Title
Evaluation of the Effectiveness of Nutritional Guidance for Preventing the Development of Oral Frailty
Scientific Title:Acronym
Evaluation of the Effectiveness of Nutritional Guidance for Preventing the Development of Oral Frailty
Region
| Japan |
Condition
Condition
Oral frailty
Classification by specialty
| Geriatrics | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify nutritional and dietary interventions that are useful in preventing the development of oral frailty.
Basic objectives2
Others
Basic objectives -Others
To identify the characteristics of subjects who are prone to oral frailty and the nutritional and dietary factors that define them.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral frailty
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Nutritional Guidance
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
Men and women over 65 years old living in the area
Key exclusion criteria
Those who have difficulty communicating or living independently due to cognitive decline
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Chika |
| Middle name | |
| Last name | Momoki |
Organization
Setsunan University
Division name
Department of food science and human nutrition, Faculty of agriculture
Zip code
5730101
Address
45-1 Nagao-toge-cho, Hirakata City
TEL
0728966207
chika.momoki@setsunan.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Nakata |
Organization
Setsunan University
Division name
Department of food science and human nutrition, Faculty of agriculture
Zip code
5730101
Address
45-1 Nagao-toge-cho, Hirakata City
TEL
0728966206
Homepage URL
eriko.nakata@setsunan.ac.jp
Sponsor or person
Institute
Setsunan University
Institute
Department
Personal name
Funding Source
Organization
Setsunan University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Setsunan University Ethical Review Committee for Medical and Health Research Involving Human Subjects
Address
45-1 Nagao-toge-cho, Hirakata City
Tel
0728001160
setsunan.kenkyu.shakai@josho.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
| 2023 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.jscn.gr.jp/activities/gakkaishi/4701.html
Publication of results
Published
Result
URL related to results and publications
https://www.jscn.gr.jp/activities/gakkaishi/4701.html
Number of participants that the trial has enrolled
13
Results
In the non-OF group, changes were observed in some nutrients and food groups after nutritional guidance was implemented, but in the OF group, no significant changes were observed in nutrient intake.In both the non-OF and OF groups, no significant changes were observed in OF status or oral function.
Results date posted
| 2025 | Year | 10 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirteen patients aged 40 or older who regularly visit one cooperating dental clinic
Participant flow
Participants were recruited by posting posters at a cooperating dental clinic and by dentists contacting them. The inclusion criteria were patients aged 40 years or older. Exclusion criteria were: 1) those with dental-oral diseases that affect oral function, 2) those who have difficulty communicating due to cognitive impairment, 3) those certified as requiring nursing care, and 4) those whose energy intake calculated from a dietary survey was less than 600 kcal or more than 4000 kcal, which are considered to be underestimates or overestimates.
Adverse events
None.
Outcome measures
Oral function, oral frailty status, nutrient and food group intakes.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 17 | Day |
Last modified on
| 2025 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057965
