UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000057734 |
|---|---|
| Receipt number | R000065924 |
| Scientific Title | Evaluation of the Effects of Preference-Oriented Dietary Modification on Swallowing Function in Acute Elderly Stroke Patients |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/15 10:15:08 |
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Basic information
Public title
Evaluation of the Effects of Preference-Oriented Dietary Modification on Swallowing Function in Acute Elderly Stroke Patients
Acronym
Evaluation of the Effects of Preference-Oriented Dietary Modification on Swallowing Function in Acute Elderly Stroke Patients
Scientific Title
Evaluation of the Effects of Preference-Oriented Dietary Modification on Swallowing Function in Acute Elderly Stroke Patients
Scientific Title:Acronym
Evaluation of the Effects of Preference-Oriented Dietary Modification on Swallowing Function in Acute Elderly Stroke Patients
Region
| Japan |
Condition
Condition
Acute stroke
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of palatability-conscious meal adjustments on swallowing function in acute stroke patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.The Mann Assessment of Swallowing Ability (MASA)
2.Functional Oral Intake Scale (FOIS), Oral Nutritional Intake
3.Simplified Nutritional Appetite Questionnaire-Japanese (SNAQ-J)
Baseline, Week1, Week2, Week3, Discharge
Key secondary outcomes
Basic information: disease information, age, gender, complications, medical history, hospitalization, hospital stay, medications, etc.
Biochemical data: ALB, WBC, CRP, BUN, Cre, Tf, Pre-ALB, etc.
Vital data: temperature, blood pressure, blood oxygen saturation, heart rate, pulse rate, etc.
Physical function: grip strength, tongue pressure, Barthel Index, Inbody, physical and cerebral palsy symptoms, etc.
Imaging data: CT, MRI, VE, VF, chest X-ray, etc.
Nutritional status: BMI, GNRI, CRP, Tf, Pre ALB, etc.
Cognitive function: MMSE, presence of dementia, etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Dining,Selection of 10 commercially available seasonings to suit your tastes
For both the intervention and control groups, the standard frequency and duration of swallowing training will be "20 minutes per session, at least 5 times per week" and will be standardized for both groups.In addition, the method of talking to and assisting the patients during the training will be uniformly applied in both groups.
Interventions/Control_2
Regular meals served
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with swallowing dysfunction (MASA score of 177 or less) as determined by our swallowing evaluation protocol.
2. Patients who are 65 years of age or older at the time of obtaining consent to participate in the study.
Key exclusion criteria
1. Patients who could not be assessed for swallowing function within 48 hours of onset
2. Patients with severe impaired consciousness, severe cognitive decline, or severe aphasia that would make intervention difficult and would make cooperation in the study difficult
3. Patients who will receive central venous nutrition with meals during the study period
4. Patients with diagnosis of lacunar infarction or subarachnoid hemorrhage (to limit stroke classification)
5. Patients with a history of dysphagia or a history of high risk of developing dysphagia (e.g., stroke, aspiration pneumonia, neuromuscular disease)
6. Patients whose general condition is poor and for whom it is deemed difficult to obtain the established assessment items
7. Patients with the following food allergies: shrimp, wheat, sesame, soybean, apple *Allergens contained in seasonings
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Yoneoka |
Organization
Niigata University Regional Medical Education Center Uonuma kikan Hospital
Division name
neurosurgery
Zip code
949-7302
Address
4132 Urasa, Minamiuonuma City, Niigata Prefecture
TEL
025-777-3200
yone.bri@niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Yoneoka |
Organization
Niigata University Regional Medical Education Center Uonuma kikan Hospital
Division name
neurosurgery
Zip code
949-7302
Address
4132 Urasa, Minamiuonuma City, Niigata Prefecture
TEL
025-777-3200
Homepage URL
yone.bri@niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Regional Medical Education Center Uonuma kikan Hospital
Institute
Department
Personal name
Funding Source
Organization
Niigata University Regional Medical Education Center Uonuma kikan Hospital
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
Uonuma kikan Hospital Ethics Committee
Address
4132 Urasa, Minamiuonuma City, Niigata Prefecture
Tel
025-777-3200
m-kaise@ncmi.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | 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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | 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 | 04 | Month | 28 | Day |
Last modified on
| 2025 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065924
