UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057621 |
|---|---|
| Receipt number | R000065836 |
| Scientific Title | Validation of the Methodology and Validity of Malnutrition Diagnosis Using the GLIM Criteria in Older Adults with Dementia |
| Date of disclosure of the study information | 2025/04/16 |
| Last modified on | 2025/04/15 16:25:07 |
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Basic information
Public title
Validation Study of a Novel Diagnostic Method for Accurately Detecting Malnutrition in Older Adults with Dementia
Acronym
VaNDA Study: Validation of a Novel Diagnostic Tool for Undernutrition in Dementia and Aging
Scientific Title
Validation of the Methodology and Validity of Malnutrition Diagnosis Using the GLIM Criteria in Older Adults with Dementia
Scientific Title:Acronym
VaNDA Study: Validation of a Novel Diagnostic Tool for Undernutrition in Dementia and Aging
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the methodology of the GLIM criteria and assess its validity in older adults with dementia who require support or long-term care but are not hospitalized, this study will (1) cross-sectionally examine the cutoff value of calf circumference for estimating reduced muscle mass, and (2) longitudinally investigate three-year survival rates stratified by nutritional status.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Three-year survival rate by nutritional status
Key secondary outcomes
Cutoff value of calf circumference
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 105 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Older adults with dementia who use group homes or small-scale multifunctional in-home care services at collaborating research facilities, and who are able to provide informed consent either personally or through a legal representative (e.g., a family member).
Key exclusion criteria
Individuals who cannot provide informed consent either personally or through a legal representative (e.g., a family member) will be excluded.
Additionally, those who are hospitalized at the time of the baseline assessment or who have been judged to be in the terminal stage with a life expectancy of several months will also be excluded.
No restrictions will be placed on the type of dementia, sex, age, or medication use at the time of recruitment.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Yasutake |
Organization
Nakamura Gakuen University
Division name
Department of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan
TEL
0928512531
yasutake@nakamura-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Yasutake |
Organization
Nakamura Gakuen University
Division name
Department of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan
TEL
092-851-2531
Homepage URL
yasutake@nakamura-u.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Nakamura Gakuen 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
Nakamura Gakuen University
Address
5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan
Tel
092-851-2531
kks@nakamura-u.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
| 2025 | Year | 04 | Month | 16 | 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
| 2024 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This observational study aims to validate the GLIM criteria for accurately assessing undernutrition in community-dwelling older adults with dementia who require support or long-term care. Through both cross-sectional and longitudinal analyses, the study seeks to contribute to improving the quality of nutritional assessment in real-world clinical settings.
Management information
Registered date
| 2025 | Year | 04 | Month | 15 | Day |
Last modified on
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065836
