UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062163 |
|---|---|
| Receipt number | R000071139 |
| Scientific Title | A multicenter randomized controlled study investigating whether the use of concentrated liquid dashi for oral care increases food intake in dementia patients with reduced food intake. |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/07 16:34:24 |
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Basic information
Public title
Research on applying dashi to oral care to increase food intake
Acronym
FIDO study
Scientific Title
A multicenter randomized controlled study investigating whether the use of concentrated liquid dashi for oral care increases food intake in dementia patients with reduced food intake.
Scientific Title:Acronym
FIDO study
Region
| Japan |
Condition
Condition
all-cause dementia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As aged society is progressing rapidly, the number of elderly with dementia is increasing. As dementia progresses, physical assistance becomes necessary for various activities of daily living (ADL). Difficulty in eating independently leads to reduced food intake and diminished vitality, creating a vicious cycle of further decline in ADL. In many cases involving elderly with dementia, cognitive decline makes it difficult to recognize food, leading to a loss of appetite and reduced food intake. In these cases, we will apply dashi to oral care and investigate whether bonito dashi's stimulation of the sense of smell, taste, and physical stimulation of the oral cavity can increase food intake. This is a multicenter randomized controlled study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Dietary intake; changes in body weight and BMI; calf circumference; changes in grip strength; presence or absence of edema; changes in nutritional status (MNA-SF, GLIM criteria).
Key secondary outcomes
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Dashi group; Oral care is performed using a frozen oral care sponge impregnated with concentrated liquid dashi diluted fourfold. This regimen is continued for two weeks, and food intake is recorded.
Interventions/Control_2
Control group; Routine care.
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
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases with dementia in which food intake over the past week decreased to 40% or less of the amount provided, based on an assessment by a registered dietitian.
Key exclusion criteria
Cases with advanced dementia where conversation is difficult and communication is extremely challenging are excluded.
Cases with severe physical complications (e.g., severe dysphagia, pneumonia, severe heart failure, chronic kidney disease stage G4 or higher, liver cirrhosis, severe ileus). If a subject in the dashi group develops pneumonia or a similar condition during the study period, their participation will be discontinued, and they will be excluded from the study.
Cases where the individual refuses to consume dashi.
Cases where consent could not be obtained from the individual or their family.
Cases where allergies or similar conditions are suspected.
Cases that participated in the "Research on increasing food intake by utilizing the dashi-flavor."
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Sadao |
| Middle name | |
| Last name | Yoshida |
Organization
Nakagami Nishi Hospital
Division name
Department of Internal Medicine
Zip code
904-2143
Address
6-25-5 Chibana, Okinawa-city
TEL
+81-98-921-0024
sadao.yoshida@mac.com
Public contact
Name of contact person
| 1st name | Sadao |
| Middle name | |
| Last name | Yoshida |
Organization
Nakagami Nishi Hospital
Division name
Department of Internal Medicine
Zip code
904-2143
Address
6-25-5 Chibana, Okinawa-city
TEL
+81-98-921-0024
Homepage URL
sadao.yoshida@mac.com
Sponsor or person
Institute
Hirosaki Aiseikai Hospital, Takutoku Ishioka
Ibusuki Takemoto Hospital, Daisuke Fukuyoshi
Kanno Hospital, Akiko Wada
Green Hills Wakakusa Hospital, Natsuko Shibahara
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Nakagami Hospital
Address
Noborikawa 610, Okinawa City
Tel
+81-98-939-1300
research@nakagami.or.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
弘前愛成会病院、指宿竹元病院、菅野病院、グリーンヒルズ若草病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | 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
| 2026 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2026 | Year | 07 | Month | 07 | Day |
Last modified on
| 2026 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071139
