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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032505
Receipt No. R000037071
Scientific Title The effects of ingestion of citrulline -containing protein nutritional supplement on rehabilitation patients
Date of disclosure of the study information 2018/05/08
Last modified on 2018/05/08

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Basic information
Public title The effects of ingestion of citrulline -containing protein nutritional supplement on
rehabilitation patients
Acronym The effects of ingestion of citrulline -containing protein nutritional supplement on
rehabilitation patients
Scientific Title The effects of ingestion of citrulline -containing protein nutritional supplement on
rehabilitation patients
Scientific Title:Acronym The effects of ingestion of citrulline -containing protein nutritional supplement on
rehabilitation patients
Region
Japan

Condition
Condition stroke patients, femoral neck fracture patients, Vertebral compression fractures
Classification by specialty
Orthopedics Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to evaluate whether the ingestion of citrulline-containing protein nutritional supplement in rehabilitation units patients could be effected with the physical performance, nutrition status and reactive oxygen species (ROS)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes fim, functional independence measure
Key secondary outcomes body composition, physical performance,nutritional status, blood flow, reactive oxygen species

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 protein nutritional supplement on rehabilitation patients for 28 days
Interventions/Control_2 citrulline (1 g)-containing protein nutritional supplement
on rehabilitation patients for 28 days
Interventions/Control_3 citrulline (3 g)-containing protein nutritional supplement
on rehabilitation patients for 28 days
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
40 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria The stable condition rehabilitation patients with stroke, femoral neck fracture and vertebral compression fractures
Key exclusion criteria acute heart failure, chronic kidney disease,liver failure
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuya Yamauchi
Organization Hamamatsu University School of Medicine, University Hospital
Division name Division of Rehabilitation
Zip code
Address 1-20-1 Handayama Higashiku, Hamamatsu, Shizuoka, Japan
TEL 053-435-2747
Email yamakatu@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuya Yamauchi
Organization Hamamatsu University School of Medicine, University Hospital
Division name Division of Rehabilitation
Zip code
Address 1-20-1 Handayama Higashiku, Hamamatsu, Shizuoka, Japan
TEL 053-435-2747
Homepage URL
Email yamakatu@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine, University Hospital Division of Rehabilitation
Enshyu Hospital Division of Rehabilitation
Institute
Department

Funding Source
Organization Otsuka phamaceutical factory
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
2018 Year 05 Month 08 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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 08 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
2018 Year 05 Month 08 Day
Last modified on
2018 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037071

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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