UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051159 |
|---|---|
| Receipt number | R000058287 |
| Scientific Title | Translational research of nutritional therapy focusing on maintaining and improving ADL of the older inpatient |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/11/24 10:59:27 |
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Basic information
Public title
Nutritional intervention study focusing on maintaining and improving ADL of the older inpatient
Acronym
Nutritional intervention study for older inpatient
Scientific Title
Translational research of nutritional therapy focusing on maintaining and improving ADL of the older inpatient
Scientific Title:Acronym
Nutritional intervention study for older inpatient
Region
| Japan |
Condition
Condition
sarcopenia, frailty, fracture, cerebral infarction
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop effective nutritional therapy focusing on maintenance and improvement of ADL in older inpatient.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in muscle mass, strength and physical function over 2 months
Key secondary outcomes
Changes in stratum corneum water content, changes in skin elasticity, and changes in blood test results (hemoglobin, aspartate aminotransferase, alanine aminotransferase, creatinine, blood urea nitrogen, estimate glomerular filtration rate, serum albumin, C-reactive protein, rapid turnover protein) over the 2 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
In the intensive nutrition group, 3 equal and enhanced protein meals (protein 1.5g/kgBW/day) are provided every day.
Interventions/Control_2
The control group will be provided with the usual hospital meals (protein 1.0g/kgBW/day).
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 old or older and who are admitted to the Recovery Rehabilitation Ward
(2) Subjects who have decreased muscle mass or grip strength
(3) Subjects who can take oral intake
Key exclusion criteria
(1) Subjects with serious heart disease, renal disease, or liver disease
(2) Those who are using steroids
(3) Individuals who have difficulty observing and evaluating dietary guidance due to dementia, mental illness, etc.
(4) Those who have implanted cardiac pacemakers or implanted cardioverter-defibrillators
(5) Individuals who are deemed inappropriate for this clinical study by the research implementation supervisor or research co-investigator
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Makabe |
Organization
Kansai Electric Power Hospital
Division name
Center for Metabolism and Clinical Nutrition
Zip code
5530003
Address
2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
TEL
+81-6-6458-5821
n-makabe@umin.ac.jp
Public contact
Name of contact person
| 1st name | Noboru |
| Middle name | |
| Last name | Makabe |
Organization
Kansai Electric Power Hospital
Division name
Center for Metabolism and Clinical Nutrition
Zip code
5530003
Address
2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
TEL
+81-6-6458-5821
Homepage URL
n-makabe@umin.ac.jp
Sponsor or person
Institute
Kansai Electric Power Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Japan Society of Metabolism and Clinical Nutrition
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
Kansai Electric Power Hospital Research Ethics Committee
Address
2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
Tel
+81-6-6458-5821
koga.kazuhiro@c3.kepco.co.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
関西電力病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 01 | 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
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | 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
| 2023 | Year | 05 | Month | 24 | Day |
Last modified on
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058287
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
