UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006238 |
|---|---|
| Receipt number | R000007380 |
| Scientific Title | Efficacy of BCAA and Vitamin D Enriched Nutritional Support for Resistance Training in Elderly Patients with Sarcopenia; A Single center, Randomized, Open-Label, Comparative Study |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2013/06/11 09:26:54 |
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Basic information
Public title
Efficacy of BCAA and Vitamin D Enriched Nutritional Support for Resistance Training
in Elderly Patients with Sarcopenia; A Single center, Randomized, Open-Label, Comparative Study
Acronym
Efficacy of BCAA and Vitamin D Enriched Nutritional Support for Resistance Training
in Elderly Patients with Sarcopenia
Scientific Title
Efficacy of BCAA and Vitamin D Enriched Nutritional Support for Resistance Training
in Elderly Patients with Sarcopenia; A Single center, Randomized, Open-Label, Comparative Study
Scientific Title:Acronym
Efficacy of BCAA and Vitamin D Enriched Nutritional Support for Resistance Training
in Elderly Patients with Sarcopenia
Region
| Japan |
Condition
Condition
Sarcopenia
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the effect of resistance training, associated or not with BCAA and Vitamin D enriched nutritional support in elderly patients with sarcopenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The change in Physical function.
Measured by Barthel Index (BI) and Functional Independence Measure (FIM).
Assessment in baseline and three months after treatment.
Key secondary outcomes
1.Muscle mass (AMA,AC,AMC,CC)
2.Muscle strength (MMT)
3.Nutritional assessment (MNA,BMI,Alb,Hb,T-Cho,ChE,TLC,BUN,Cr,vitamin-D,CRP)
4.Cognitive function (HDS-R,FIM)
Assessment in baseline and three months after treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Resistance training with Dietary Supplement; Resource PemPal ACTIVE
Interventions/Control_2
Resistance training
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.Elderly patients over 65 years of age hospitalized in Sakurajyuji-Hospital, Recovery rehabilitation unit, since September 2011.
2.Diagnosed of sarcopenia by measurement of AMA; AMA<28.32cm2 for male, AMA<20.93cm2 for female (JARD 2011,5th percentile of AMA)
3.Good general condition
4.Good wakefulness (Japan coma scale<I-1)
5.Appropriate nutritional management (Energy administration meets TEE)
Key exclusion criteria
1.Uncontrolled co-morbidities
2.Severe dementia (Revised Hasegawa's dementia scale; HDS-R<10 points)
3.Severe renal dysfunction (eGFR<60)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Yoshimura |
Organization
Sakurajyuji Hospital
Division name
medical office
Zip code
Address
1-1-1 Miyuki-kibe, Kumamoto City, Kumamoto Prefecture
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Yoshimura |
Organization
Sakurajyuji Hospital
Division name
medical office
Zip code
Address
TEL
Homepage URL
hanley.belfus@gmail.com
Sponsor or person
Institute
Sakurajyuji Hospital
Institute
Department
Personal name
Funding Source
Organization
nestle
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
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
桜十字病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | 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
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 26 | Day |
Last modified on
| 2013 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007380
