UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of branched-chain amino acids (BCAA) supplementation for patients with non alcoholic fatty liver disease (NAFLD)
Title of the study (Brief title)	Effect of BCAA for NAFLD
Region	Japan

Condition
Condition	nonalcoholic fatty liver disease
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of study is to evaluate the effect of branched-chain amino acid supplementation for patients with fatty liver disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	To evaluate the liver function and insulin resistance at 12 weeks
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Branched-chain amino acids (BCAA)
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patient with fatty liver. 2. Patient with insulin resistance (HOMA-R>=2) or hyperglycemia [fasting blood glucose >=126mg/dl or (blood glucose at 2 hr)>=200mg/dl in oral glucose tolerance test]. 3. Patient with abnormal ALT and/or ganma-GTP.
Key exclusion criteria	1. Patient with viral hepatitis. 2. Alcohol consumer [alcohol intake (ethanol)>=20g/day]. 3. Patient with Hepatocellular carcinoma. 4. Diabetes patients treated with insulin or oral antihyperglycemic drug or uncontrolled patients (HbA1c>=8). 5. Patients who have already been taking BCAA. 6. Subjects who have already been taking amino-acid supplement. 7. Patients with amino-acid metabolism abnormality. 8. Subjects who are judged for non-approved by principal investigator.
Target sample size	15

Research contact person
Name of lead principal investigator	HirohitoTsubouchi
Organization	Kagoshima University Hospital
Division name	Center for Gastroenterology
Address	8-35-1 Sakuragaoka, Kagoshima, Japan
TEL	099-275-5326
Email	htsubo@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Hirofumi Uto
Organization	Kagoshima University Hospital
Division name	Center for Gastroenterology
Address	8-35-1 Sakuragaoka, Kagoshima, Japan
TEL	099-275-5326
Homepage URL
Email	hirouto@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University hospital, Center for Gastroenterology, Gastroenterological Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Organization
Division
Category of Funding Organization	Self funding
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	鹿児島大学病院

Other administrative information
Date of disclosure of the study information	2011 Year 02 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 07 Month 28 Day
Anticipated trial start date	2010 Year 08 Month 01 Day
Last follow-up date	2013 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 01 Month 27 Day
Last modified on	2016 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003022