UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057213 |
|---|---|
| Receipt number | R000065390 |
| Scientific Title | Clinical study on the effects of a nutritional supplement intake on nutritional status and appetite. |
| Date of disclosure of the study information | 2025/03/05 |
| Last modified on | 2025/09/03 11:34:51 |
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Basic information
Public title
Clinical study on the effects of a nutritional supplement intake on nutritional status and appetite.
Acronym
Clinical study on the effects of a nutritional supplement intake on nutritional status and appetite.
Scientific Title
Clinical study on the effects of a nutritional supplement intake on nutritional status and appetite.
Scientific Title:Acronym
Clinical study on the effects of a nutritional supplement intake on nutritional status and appetite.
Region
| Japan |
Condition
Condition
Under-nutritional condition
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of a nutritional supplement on the nutritional status and appetite of the hospitalized patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anthropometry(weight, body composition), blood tests (Alb, glucose metabolism, etc.), hospital meal eating rate, appetite survey (questionnaire form)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Taking orally one pack of nutritional supplement per day for 12 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who are 65 years of age or older
(2) Patients who are hospitalized at Tsurukawa Sanatorium Hospital
(3) Patients who are able to eat and drink orally
(4) Patients who obtain their daily required energy from hospital meals must meet either condition 1 or condition 2 below
Condition 1: Patients whose stable intake are more than 70% but less than 80% of their hospital meal
Condition 2: Patients whose stable intake are more than 80% of their hospital meal and their BMI are less than 21.5
(5) Patients who have blood tests conducted once every three months
Key exclusion criteria
(1) Patients receiving tube feeding or intravenous nutrition
(2) Patients with severe edema, ascites, or pleural effusion
(3) Patients who have allergic symptoms due to intake of milk or soy-derived ingredients
(4) Persons who are participating in other clinical trials or who plan to participate in other clinical trials during the study period
(5) Patients who are judged to be unsuitable as subjects by the investigator or subinvestigator based on the subject background, symptoms, clinical laboratory values, etc.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shigemitsu |
| Middle name | |
| Last name | Hayashi |
Organization
IMS Group Medical Corporation Meirikai
Division name
Tsurukawa Sanatorium Hospital
Zip code
195-0051
Address
197 Shinkoji-machi, Machida-city, Tokyo
TEL
042-735-2222
hayashi.shigemitsu@ims.gr.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Ito |
Organization
Morinaga Milk Industry Co., Ltd.
Division name
Health Care & Nutritional Science Institute, R&D Division
Zip code
252-8583
Address
1-83, 5-Chome, Higashihara, Zama-City, Kanagawa-Pref, Japan
TEL
046-252-3057
Homepage URL
a-asao@morinagamilk.co.jp
Sponsor or person
Institute
IMS Group Medical Corporation Meirikai Tsurukawa Sanatorium Hospital
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Meirikai Tsurukawa Sanatorium Hospital Ethics committee
Address
197 Shinkoji-machi, Machida-city, Tokyo
Tel
042-735-2222
eiyouka3710@ims.gr.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 | 03 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | 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 | 03 | Month | 05 | Day |
Last modified on
| 2025 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065390
