UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of administering at early stage of BCAA supplementation
Acronym	Efficacy of administering at early stage of BCAA supplementation
Scientific Title	Efficacy of administering at early stage of BCAA supplementation
Scientific Title:Acronym	Efficacy of administering at early stage of BCAA supplementation
Region	Japan

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

Objectives
Narrative objectives1	The effectiveness of administering at the early stage of the BCAA food in the compensatory cirrhosis patient to the glucose intolerance is examined.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	75g oral glucose tolerance test, HOMA-IR (homeostasis model assessment-insulin resistance) and after 12 weeks from the beginning of the dairy branched-chain amino acid supplementation intake
Key secondary outcomes	Serum albumin revel, BTR, Zn, platelet, Quality of Life(SF-36) and Urinary 8-OHdG excretion after 12 weeks from the beginning of the dairy BCAA 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	BCAA supplementation (BCAA3.2g) is taken 12 weeks continuously three times a day.
Interventions/Control_2	Dietary intake of 12 weeks according to usual nourishment guidance
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. Compensated cirrhosis 2. Serum albumin revel; 3.5-4.0mg/dL 3. Patients who give documentary informed consent voluntarily 4. Patient who fills all of the above-mentioned 1-3
Key exclusion criteria	1. Decompensated cirrhosis 2. Patient with serious glucose intolerance 3. Patient who has allergy in element of AMINOFEEL 4. Patient who has infectious disease that becomes problem in clinical 5. Patient inappropriate for participating to this study decided by the attending physicians
Target sample size	40

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

Public contact
Name of contact person	1st name Middle name Last name Masaki Saito
Organization	Hyogo College of Medicine
Division name	Division of Hepatobiliary and Pancreatic Diseases
Zip code
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	None
Organization
Division
Category of Funding Organization	Self funding
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	2009 Year 12 Month 14 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	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=R000003515