UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of BCAA-enriched supplement for older patients with hip fracture surgery in Kaifukuki Rehabilitation Ward.
Title of the study (Brief title)	Prospective study of BCAA-enriched supplement for older patients with hip fracture surgery in Kaifukuki Rehabilitation Ward.
Region	Japan

Condition
Condition	sarcopenia/hip fracture
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of Branched-Chain Amino Acid(BCAA)-enriched supplement on muscle mass and strength and ADL status in older patients with hip fracuture surgery in Kaifukuki Rehabilitation Ward.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Muscle mass/muscle strength/ADL once every 2-4 weeks 1) Muscle mass(BIA method) 2) Muscle strength(hand grip, knee extension muscle strength) 3) ADL(FIM,10m walk test)
Key secondary outcomes

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	Daily intake of BCAA-enriched supplement after rehabilitation
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	Postoperative hip fracture patients in Kaifukuki Rehabilitation Ward. 1) Patients with adequate oral intake 2) BMI<25
Key exclusion criteria	1) Patients with co-morbid disease which might affect evaluation of study, such as infectious disease. 2) Patients allergic to milk and soybeans. 3) Patients who are judged inappropriate for the study by the physician. 4) Patients with decreased renal function (eGFR<30)
Target sample size	45

Research contact person
Name of lead principal investigator	Yoshihiro Miyata
Organization	Research Institute for Radiation Biology and Medicine
Division name	surgical oncology
Address	1-2-3, Kasumi, Minami-ku
TEL	082-257-5869
Email	ymiyata@hiroshima-u.ac.jp

Public contact
Name of contact person	Keizo Misumi
Organization	Research Institute for Radiation Biology and Medicine
Division name	surgical oncology
Address	1-2-3, Kasumi, Minami-ku
TEL	082-257-5869
Homepage URL
Email	misumik@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima university
Institute
Department

Funding Source
Organization	Clinico Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 28 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 08 Month 03 Day
Anticipated trial start date	2016 Year 10 Month 28 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	2016 Year 09 Month 14 Day
Last modified on	2016 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027689