UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037588 |
|---|---|
| Receipt number | R000042850 |
| Scientific Title | The effects of BCAA enriched nutritional supplementation and exercise on nutritional status in a long term care ward: parallel, open-labeled, randomized control trial |
| Date of disclosure of the study information | 2019/08/04 |
| Last modified on | 2020/11/09 11:04:15 |
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Basic information
Public title
The effects of BCAA enriched nutritional supplementation and exercise on nutritional status in a long term care ward: parallel, open-labeled, randomized control trial
Acronym
The effects of BCAA enriched nutritional supplementation and exercise on nutritional status in a long term care ward - RCT -
Scientific Title
The effects of BCAA enriched nutritional supplementation and exercise on nutritional status in a long term care ward: parallel, open-labeled, randomized control trial
Scientific Title:Acronym
The effects of BCAA enriched nutritional supplementation and exercise on nutritional status in a long term care ward - RCT -
Region
| Japan |
Condition
Condition
Patients with walking difficulties
Classification by specialty
| Medicine in general | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study is aimed to examine the effects of BCAA enriched nutritional supplementation and exercise on nutritional status in a long term care ward.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Degree of improvement of FIM
FIM is estimated as initiation and every one month
Key secondary outcomes
Nutritional status(physical status and blood test), motor function, mascle mass(InBodyS10)
Contents are estimated as initiation and every one month
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
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Stand/Gait training by therapist and BCAA enriched nutritional supplementation(1 bag per day)
Interventions/Control_2
Stand/Gait training by therapist
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with walking difficulties in a long term care ward
The patients who are available for a caloric intake
The patients who can conduct study continuously
Patients with agreement of study.
Key exclusion criteria
Severe endocrinal disorder, liver disfunction. Patient with cancer.
The patients who cannot take in jelly
Target sample size
86
Research contact person
Name of lead principal investigator
| 1st name | Yasunori |
| Middle name | |
| Last name | Miyamoto |
Organization
Miyamoto hospital
Division name
Department of internal medicine
Zip code
300-0606
Address
1247, Kouda, Inashiki, Ibaraki
TEL
0299-79-2114
miyamoto.h.1247@ceres.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Yasunori |
| Middle name | |
| Last name | Miyamoto |
Organization
Miyamoto hospital
Division name
Department of internal medicine
Zip code
300-0606
Address
1247, Kouda, Inashiki, Ibaraki
TEL
0299-79-2114
Homepage URL
miyamoto.h.1247@ceres.ocn.ne.jp
Sponsor or person
Institute
Miyamoto hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miyamoto hospital
Address
1247, Kouda, Inashiki, Ibaraki
Tel
0299792114
miyamoto.h.1247@ceres.ocn.ne.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
| 2019 | Year | 08 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 02 | Day |
Last modified on
| 2020 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042850
