UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of BCAA food additional intake added to dosage of medicine made of BCAA
Acronym	Efficacy of BCAA food addition intake in BCAA replenishment treatment
Scientific Title	Efficacy of BCAA food additional intake added to dosage of medicine made of BCAA
Scientific Title:Acronym	Efficacy of BCAA food addition intake in BCAA replenishment treatment
Region	Japan

Condition
Condition	decompensated cirrhosis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effectiveness of the BCAA food addition intake in the BCAA substitution therapy to serum BTR and serum albumin is examined
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Serum BTR (branched chain amino acids / tyrosine molar ratio) and serum albumin revel after 12 weeks from the beginning of the dairy branched-chain amino acid supplementation intake
Key secondary outcomes	Quality of Life(SF-36) and Urinary 8-OHdG(8-Hydroxydeoxyguanosine) excretion after 12 weeks from the beginning of the dairy branched-chain amino acid supplementation intake

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Medicine made of BCAA granules (4.0g) is taken 12 weeks continuously three times a day. In addition, the BCAA supplementation (3.2g) is taken as late evening snack every day.
Interventions/Control_2	Medicine made of BCAA granules (4.0g) is taken 12 weeks continuously three times a day.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Decompensated cirrhosis 2. The dietary intake is possible. 3. Hypoalbuminemia 4. Patients who give documentary informed consent voluntarily 5. Patient who fills all of the above-mentioned 1-4
Key exclusion criteria	1. Patient who doesn't belong to application object of LIVACT 2. Patient who has the past of hepatic encephalopathy 3. Patient who has allergy in element of AMINOFEEL 4. The dietary intake is not enough in anorexia etc. , and the serum albumin is patients who decreased 0.1mg/dL or more in the past two months. 5. Patient who has infectious disease that becomes problem in clinical 6. Patient with serious glucose intolerance, respiratory failure and renal failure 7. Patient inappropriate for participating to this study decided by the attending physicians
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Shuhei Middle name Last name Nishiguchi
Organization	Hyogo College of Medicine
Division name	Division of Hepatobiliary and Pancreatic Diseases
Zip code	663-8501
Address	1-1 Mukogawa, Nishinomiya, Hyogo, JAPAN
TEL	0798-45-6472
Email	nishiguc@hyo-med.ac.jp

Public contact
Name of contact person	1st name Masaki Middle name Last name Saito
Organization	Hyogo College of Medicine
Division name	Division of Hepatobiliary and Pancreatic Diseases
Zip code	663-8501
Address	1-1 Mukogawa, Nishinomiya, Hyogo, JAPAN
TEL	0798-45-6472
Homepage URL
Email	he-jishu@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hyogo College of Medicine
Address	Mukogawa-cho 1-1, Mishinomiya, Hyogo
Tel	0798-45-6154
Email	shomu@hyo-med.ac.jp

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	2009 Year 12 Month 14 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000003511
Publication of results	Unpublished

Result
URL related to results and publications	No publication
Number of participants that the trial has enrolled	0
Results	No entry
Results date posted	2020 Year 03 Month 31 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	No entry
Participant flow	No entry
Adverse events	No entry
Outcome measures	No entry
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 09 Month 01 Day
Date of IRB	2009 Year 10 Month 15 Day
Anticipated trial start date	2009 Year 11 Month 01 Day
Last follow-up date	2011 Year 03 Month 01 Day
Date of closure to data entry	2011 Year 06 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 12 Month 14 Day
Last modified on	2020 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003511