UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016232 |
|---|---|
| Receipt number | R000018836 |
| Scientific Title | The intervention study of leucine enriched jelly on ADL improvement in the elderly requiring long-term care. |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2017/07/19 10:20:20 |
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Basic information
Public title
The intervention study of leucine enriched jelly on ADL improvement in the elderly requiring long-term care.
Acronym
The intervention study of leucine enriched jelly on ADL improvement in the elderly requiring long-term care.
Scientific Title
The intervention study of leucine enriched jelly on ADL improvement in the elderly requiring long-term care.
Scientific Title:Acronym
The intervention study of leucine enriched jelly on ADL improvement in the elderly requiring long-term care.
Region
| Japan |
Condition
Condition
The elderly requiring long-term care
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of leucine enriched jelly for ADL improvement in the elderly requiring long-term care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
FIM (Functional Independence Measure)
Key secondary outcomes
Nutrition and clinical test data, muscle mass and muscle strength.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Leucine enriched jelly
Period of 12 weeks
Daily dose 100 g
Number-frequency once a day
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
Geriatric health services facilities residents.
Aged 65 years and older.
Oral ingestion of universal design Food Category 4 or more is possible.
Key exclusion criteria
Unable to understand the explanation of study.
Leucine enriched jelly intake denial cases.
Apple allergy.
Stage of chronic kidney disease G4, G5 without dialysis.
Vitamin D intake in sum of diet and nutritional supplements is more than 4000IU.
Inappropriate to participate judged by doctors.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetaka Wakabayashi |
Organization
Yokohama City University Medical Center
Division name
Department of Rehabilitation Medicine
Zip code
Address
4-57 Urafune-chou, Minami ward, Yokohama city
TEL
045-261-5656
noventurenoglory@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuko Karibe |
Organization
Nursing home Rihab-park Maioka
Division name
Nutrition Division
Zip code
Address
3048-4 Maioka-cho, Totsuka ward, Yokohama city
TEL
045-825-3388
Homepage URL
Karibe-yasuko@shinzen.jp
Sponsor or person
Institute
Nursing home Rihab-park Maioka
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
Ajinomoto Co., Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
介護老人保健施設 リハパーク舞岡(神奈川県)
Nursing home Rihab-park Maioka (Kanagawa Prefecture)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2016 | 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
| 2015 | Year | 01 | Month | 16 | Day |
Last modified on
| 2017 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018836
| Research Plan | |
|---|---|
| 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 |
