UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061009 |
|---|---|
| Receipt number | R000069634 |
| Scientific Title | Nutritional improvement trial to reduce early undernutrition risk in healthy older adults (pilot): a four-arm randomized controlled trial comparing add-on nutritional supplementation or nutrition counseling within a community-based multimodal program |
| Date of disclosure of the study information | 2026/03/23 |
| Last modified on | 2026/03/17 01:29:00 |
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Basic information
Public title
Community-based multimodal program with nutritional support to improve early undernutrition risk in healthy older adults: pilot trial
Acronym
EUNS-Nutrition Pilot
Scientific Title
Nutritional improvement trial to reduce early undernutrition risk in healthy older adults (pilot): a four-arm randomized controlled trial comparing add-on nutritional supplementation or nutrition counseling within a community-based multimodal program
Scientific Title:Acronym
EUNS-NUT pilot
Region
| Japan |
Condition
Condition
Early undernutrition risk
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To pilot-test and compare the effects of three add-on nutritional support options (balanced ONS, protein-fortified beverage, or nutrition counseling) within a community-based multimodal program on early undernutrition risk (EUNS) and related outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in early undernutrition risk score (EUNS) from baseline to 6 months
Key secondary outcomes
MNA-SF, CL-15, GDS-5, body weight, BMI, FFMI, SNAQ, handgrip strength, five-times sit-to-stand test, etc. (baseline and 6 months)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Arm A: Balanced oral nutritional supplement (125 mL twice/day; 400 kcal/day; 15 g protein/day)
Interventions/Control_2
Arm B: Protein-fortified beverage (200 mL once/day; 15 g protein/day)
Interventions/Control_3
Arm C: Nutrition counseling targeting dietary diversity
Interventions/Control_4
Arm D: Control (no additional nutrition component)
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Older adults living in the target community
2) Able to participate in group sessions and home-based activities/self-monitoring
3) Provided written informed consent
Key exclusion criteria
1) Individuals with blood pressure or pulse significantly deviating from normal ranges (e.g., resting systolic blood pressure >=180 mmHg or diastolic blood pressure >=110 mmHg, resting pulse rate >=110 beats/min or <=50 beats/min, etc.), or showing marked differences from usual levels
2) Individuals with severe heart disease, kidney disease, liver disease, respiratory disease, circulatory disease, musculoskeletal disease, or other progressive chronic conditions or symptoms
3) Individuals exhibiting significant cognitive decline
4) Individuals with food allergies or lactose intolerance symptoms (frequent abdominal pain or diarrhea after consuming dairy products)
5) Individuals requiring protein intake restriction
6) Individuals who participated in any other clinical trial within the 3 months prior to the study, including the present trial
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shoji |
| Middle name | |
| Last name | Shinkai |
Organization
Kagawa Nutrition University
Division name
Faculty of Nutrition, Department of Nutrition Sciences
Zip code
350-0288
Address
3-9-21, Chiyoda, Sakado-city, Saitama
TEL
+81-49-282-3464
shinkai.shoji@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Narita |
Organization
Tokyo Online University
Division name
Faculty of Human Welfare
Zip code
160-0023
Address
1-7-3, Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
+81-3-3344-2222
Homepage URL
narita.miki@internet.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Name of secondary funder(s)
Japan Diary Association (J-milk), Dairy Products Health Science Council
IRB Contact (For public release)
Organization
Kagawa Nutrition University Research Support Division
Address
3-9-21, Chiyoda, Sakado-city, Saitama
Tel
+81-49-282-1353
kenshien@eiyo.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 | 03 | Month | 23 | 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
80
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Results posting is delayed due to final data verification (including sensitivity analyses) and manuscript preparation.
Results will be posted on UMIN-CTR by 30 Sep 2026.
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
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was conducted before clinical trial registration, and retrospectively registered.
Retrospective registration occurred due to transition of responsibility.
The registration record reflects the original study plan.
Management information
Registered date
| 2026 | Year | 03 | Month | 22 | Day |
Last modified on
| 2026 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069634
