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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004972
Receipt No. R000003022
Scientific Title Effect of branched-chain amino acids (BCAA) supplementation for patients with non alcoholic fatty liver disease (NAFLD)
Date of disclosure of the study information 2011/02/01
Last modified on 2016/05/25

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Basic information
Public title Effect of branched-chain amino acids (BCAA) supplementation for patients with non alcoholic fatty liver disease (NAFLD)
Acronym Effect of BCAA for NAFLD
Scientific Title Effect of branched-chain amino acids (BCAA) supplementation for patients with non alcoholic fatty liver disease (NAFLD)
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name HirohitoTsubouchi
Organization Kagoshima University Hospital
Division name Center for Gastroenterology
Zip code
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
1st name
Middle name
Last name Hirofumi Uto
Organization Kagoshima University Hospital
Division name Center for Gastroenterology
Zip code
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

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)

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 鹿児島大学病院

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

Related information
URL releasing protocol
Publication of results Partially published

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
2010 Year 07 Month 28 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000003022

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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