UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061417 |
|---|---|
| Receipt number | R000070276 |
| Scientific Title | Designing elderly meals focused on high-calorie density |
| Date of disclosure of the study information | 2026/04/30 |
| Last modified on | 2026/04/30 16:56:28 |
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Basic information
Public title
Designing elderly meals focused on high-calorie density
Acronym
Designing elderly meals focused on high-calorie density
Scientific Title
Designing elderly meals focused on high-calorie density
Scientific Title:Acronym
Designing elderly meals focused on high-calorie density
Region
| Japan |
Condition
Condition
elderly
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Meal planning for high-calorie-density diets that ensure adequate energy intake for older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint will be a subjective assessment using the VAS test.
(Before and after food intake)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
We will conduct visual and taste tests.
Interventions/Control_2
We will conduct visual and taste tests.
Interventions/Control_3
We will conduct visual and taste tests.
Interventions/Control_4
We will conduct visual and taste tests.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
There is no evidence of impaired swallowing function, and the patient is able to consume meals of the same consistency as their usual diet without difficulty.
Key exclusion criteria
People who have difficulty consuming the meals provided.In addition,people who cannot obtain permission to participate in the study from their physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hisami |
| Middle name | |
| Last name | Okumura |
Organization
Doshisha Women's College of Liberal Arts
Division name
Division of Food and Nutritional Sciences, Department of Life Sciences
Zip code
602-0893
Address
Teramachi Nishiiru, Imadegawa-dori, Kamigyo-ku, Kyoto-city
TEL
075-251-4247
hls007@dwc.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Hisami |
| Middle name | |
| Last name | Okumura |
Organization
Doshisha Women's College of Liberal Arts
Division name
Division of Food and Nutritional Sciences, Department of Life Sciences
Zip code
602-0893
Address
Teramachi Nishiiru, Imadegawa-dori, Kamigyo-ku, Kyoto-city
TEL
075-251-4247
Homepage URL
hls007@dwc.doshisha.ac.jp
Sponsor or person
Institute
Division of Food and Nutritional Sciences, Department of Life Sciences
Institute
Department
Personal name
Funding Source
Organization
Division of Food and Nutritional Sciences, Department of Life Sciences
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Doshisha Women's College of Liberal Arts Academic Research Support Section, Academic Information Department
Address
Koudo Minami Hokodate,97-1, Kyotanabe-city, Kyoto
Tel
0774-65-8679
research@dwc.doshisha.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
| 2026 | Year | 04 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2030 | Year | 06 | 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
| 2026 | Year | 04 | Month | 30 | Day |
Last modified on
| 2026 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070276
