UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004972 |
|---|---|
| Receipt number | 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 18:44:22 |
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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
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
hirouto@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University hospital, Center for Gastroenterology, Gastroenterological Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003022
