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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006238
Receipt No. 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

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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
Email

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
Email hanley.belfus@gmail.com

Sponsor
Institute Sakurajyuji Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007380

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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