UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060618 |
|---|---|
| Receipt number | R000069334 |
| Scientific Title | Impact of Enhanced Visual Contrast on Food Intake in Older Adults on Texture-Modified Diets: A Randomized Crossover Controlled Trial |
| Date of disclosure of the study information | 2026/02/09 |
| Last modified on | 2026/02/08 14:55:18 |
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Basic information
Public title
Effect of Visually Enhanced Texture-Modified Diet on Food Intake in Older Adults
Acronym
Visual Enhancement of Texture-Modified Diet
Scientific Title
Impact of Enhanced Visual Contrast on Food Intake in Older Adults on Texture-Modified Diets: A Randomized Crossover Controlled Trial
Scientific Title:Acronym
Visual Enhancement Trial for Improvement of Texture-Modified Diet Intake
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine whether black tableware, compared with white tableware, increases food intake in older adults aged 65 years or older who consume texture-modified diets. Using a randomized controlled crossover design, this study also examines the effects of tableware color on meal duration and evaluates the effectiveness of a practical nutritional intervention that enhances visual appearance without additional cooking costs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean energy intake (kcal)
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
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A texture-modified diet will be served on black tableware (standard care) once daily at lunch for 3 consecutive days.
Interventions/Control_2
A texture-modified diet will be served on white tableware (standard care) once daily at lunch for 3 consecutive days.
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.Aged 65 years or older at the time of enrollment
2.Consuming texture-modified diets classified as Code 2 or Code 3 according to the Japanese Society of Dysphagia Rehabilitation Classification 2021
3.Capable of independent oral intake
Key exclusion criteria
1.Withdrawal of consent to participate in the study
2.Inability to perform independent oral intake
3.Medically unstable condition (requiring intravenous infusion, oxygen therapy, presence of fever, or continuous vital sign monitoring)
4.Severe visual impairment with official certification of visual disability
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Ueshima |
Organization
Hospital, National Center for Geriatrics and Gerontology
Division name
Department of Geriatric Medicine
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi 474-8511, Japan
TEL
0562-46-2311
junko.ueshima@east.ntt.co.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Ueshima |
Organization
NTT Medical Center Tokyo
Division name
Department of Nutritional service
Zip code
141-8625
Address
5-9-22 Higashi-Gotanda, Shinagawa, Tokyo, Japan
TEL
03-3448-6111
Homepage URL
junko.ueshima@east.ntt.co.jp
Sponsor or person
Institute
Hospital, National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT), Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
NTT Medical Center Tokyo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hospital, National Center for Geriatrics and Gerontology
Address
7-430 Morioka-cho, Obu, Aichi 474-8511, Japan
Tel
0562-46-2311
yaday@ncgg.go.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 | 02 | Month | 09 | 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 | 11 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 05 | 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 | 02 | Month | 08 | Day |
Last modified on
| 2026 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069334
