UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007260 |
|---|---|
| Receipt number | R000008568 |
| Scientific Title | Efficacy of oral supplementation with branched-chain amino acid granules for patients with non-alcoholic fatty liver disease(NAFLD):pilot study |
| Date of disclosure of the study information | 2012/02/10 |
| Last modified on | 2013/08/20 18:22:40 |
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Basic information
Public title
Efficacy of oral supplementation with branched-chain amino acid granules for patients with non-alcoholic fatty liver disease(NAFLD):pilot study
Acronym
LIVACT NAFLD Trial
Scientific Title
Efficacy of oral supplementation with branched-chain amino acid granules for patients with non-alcoholic fatty liver disease(NAFLD):pilot study
Scientific Title:Acronym
LIVACT NAFLD Trial
Region
| Japan |
Condition
Condition
nonalcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of branched-chain amino acid granules for patients with with nonalcoholic fatty liver disease(NAFLD)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
insulin resistance(HOMA-IR)
Key secondary outcomes
thioredoxin, oxidative stress
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 acid granules
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. BMI>25 kg/m2
2. Patient with fatty liver.
3. Obesty, Metabolic syndrome, Diabetes mellitus, Hypertension, dyslipidemia
4. HBs antigen negative, HCV antibody negative, Antinuclear antibody negative, Antimitochondrial antibody negative
5. Alcohol intake(ethanol)<=20g/day
Key exclusion criteria
1. Subjects with a history of oral branched-chain amino acid granule use within 6 months
2. Patients with branched-chain amino acid metabolism abnormality
3. Diabetes patients treated with insulin
4. Patients with nonalcoholic steatohepatitis
5. Subjects who are judged for non-approved by investigator.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Suzuki |
Organization
Iwate Medical University
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine
Zip code
Address
19-1 Uchimaru, Morioka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryujin Endo |
Organization
Iwate Medical University
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine
Zip code
Address
19-1 Uchimaru, Morioka, Japan
TEL
019-651-5111
Homepage URL
Sponsor or person
Institute
Iwate Medical University
Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine
Institute
Department
Personal name
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
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
岩手医科大学附属病院（岩手県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 10 | 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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 10 | Day |
Last modified on
| 2013 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008568
