UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059498 |
|---|---|
| Receipt number | R000068057 |
| Scientific Title | A case study on nutritional management of hospitalized patients receiving viscosity-adjusted liquid diets in actual clinical practice |
| Date of disclosure of the study information | 2025/10/23 |
| Last modified on | 2025/10/22 10:48:24 |
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Basic information
Public title
A case study on nutritional management of hospitalized patients receiving viscosity-adjusted liquid diets in actual clinical practice
Acronym
A case study on nutritional management using viscosity-adjusted liquid diets
Scientific Title
A case study on nutritional management of hospitalized patients receiving viscosity-adjusted liquid diets in actual clinical practice
Scientific Title:Acronym
A case study on nutritional management using viscosity-adjusted liquid diets
Region
| Japan |
Condition
Condition
Patients receiving enteral nutrition
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the effects of viscosity-adjusted liquid diets on nutritional status, fever, and gastrointestinal symptoms such as diarrhea and vomiting
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
body weight
Key secondary outcomes
gastrointestinal symptoms (frequency of vomiting and diarrhea), bowel movement status (frequency and stool characteristics), frequency of fever, and nutritional status (serum albumin levels)
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
Administer a viscosity-adjusted liquid diet 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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Subjects receiving enteral nutrition
2.Subjects aged 50 years or older
3.Subjects expected to continue enteral nutrition for at least one month
Key exclusion criteria
1.Subjects in a severe condition with unstable symptoms due to liver, kidney, heart, lung, digestive system, hematological, endocrine, or metabolic disorders, who may be at risk of death during the study period
2.Subjects with a history of drug allergy or severe food allergy
3.Subjects currently participating in clinical trials related to pharmaceuticals
4.Subjects whose administered caloric intake via enteral nutrition has not been stable within the past month
5.Subjects judged by the principal investigator or sub-investigator to be unsuitable as study subjects
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Serita |
Organization
Michinoo Hospital
Division name
Psychiatry
Zip code
852-8055
Address
1-1, Nijigaoka, Nagasaki, Nagasaki, Japan
TEL
095-856-1111
dr-serita@michinoo.or.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Serita |
Organization
Michinoo hospital
Division name
Psychiatry
Zip code
852-8055
Address
1-1, Nijigaoka, Nagasaki, Nagasaki, Japan
TEL
095-856-1111
Homepage URL
dr-serita@michinoo.or.jp
Sponsor or person
Institute
Michinoo 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
Ethics Review Committee, Michinoo Hospital
Address
1-1, Nijigaoka, Nagasaki, Nagasaki, Japan
Tel
095-856-1111
dr-serita@michinoo.or.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 | 10 | 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
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 | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2025 | Year | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068057
