UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized trial to evaluate the efficacy of Branched-Chain Amino Acid fortified supplements in post-stroke rehabilitation patients.
Title of the study (Brief title)	A randomized trial to evaluate the efficacy of Branched-Chain Amino Acid fortified supplements in post-stroke rehabilitation patients.
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Geriatrics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of Branched-Chain Amino Acid fortified supplements on improvement of activities of daily living in post-stroke rehabilitation patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Activities of daily living Assessment in baseline and three months after treatment
Key secondary outcomes	1. Skeletal muscle mass (by body composition analysis) 2. Muscle strength (hand grip) 3. Swallowing ability (tongue pressure, eating and swallowing status) 4.Nutritional status

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	1.Branched-Chain Amino Acid fortified supplements Jelly type supplements 1bag per day(BCAA2500mg) Three month intervention 2.Rehabilitation
Interventions/Control_2	1.Rehabilitation
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.Stroke patients aged 65 or older 2.Appropriate nutritional management 3.Patients who can stand with or without assistance
Key exclusion criteria	1. Decreased level of consciousness 2. Severe dysphagia 3. Severe renal dysfunction 4. Obesity 5. Patients who are judged inappropriate for the study by the physician
Target sample size	60

Research contact person
Name of lead principal investigator	Rei Fujii
Organization	Yamaguchi Rehabilitation Hospital
Division name	Rehabilitation center
Address	3380Kurokawa,Yamaguchi-city,Yamaguchi prefecture
TEL	0839211616
Email	rei.suzu.rin@gmail.com

Public contact
Name of contact person	Rei Fujiii
Organization	Yamaguchi Rehabilitation Hospital
Division name	Rehabilitation center
Address	3380Kurokawa,Yamaguchi-city,Yamaguchi prefecture
TEL	0839211616
Homepage URL
Email	rei.suzu.rin@gmail.com

Sponsor
Institute	Yamaguchi Rehabilitation Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	1.Clinico Co., Ltd. 2.Kumamoto Rehabilitation Hospital Department of Rehabilitation Yoshihiro Yoshimura
Name of secondary funｄer(s)

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	山口リハビリテーション病院（山口県）

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 10 Month 30 Day
Anticipated trial start date	2015 Year 11 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 10 Month 31 Day
Last modified on	2016 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022615