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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024044
Receipt No. R000027689
Scientific Title Prospective study of BCAA-enriched supplement for older patients with hip fracture surgery in Kaifukuki Rehabilitation Ward.
Date of disclosure of the study information 2016/10/28
Last modified on 2016/09/14

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Basic information
Public title Prospective study of BCAA-enriched supplement for older patients with hip fracture surgery in Kaifukuki Rehabilitation Ward.
Acronym Prospective study of BCAA-enriched supplement for older patients with hip fracture surgery in Kaifukuki Rehabilitation Ward.
Scientific Title Prospective study of BCAA-enriched supplement for older patients with hip fracture surgery in Kaifukuki Rehabilitation Ward.
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshihiro Miyata
Organization Research Institute for Radiation Biology and Medicine
Division name surgical oncology
Zip code
Address 1-2-3, Kasumi, Minami-ku
TEL 082-257-5869
Email ymiyata@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keizo Misumi
Organization Research Institute for Radiation Biology and Medicine
Division name surgical oncology
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 28 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 Enrolling by invitation
Date of protocol fixation
2016 Year 08 Month 03 Day
Date of IRB
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

Other
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027689

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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