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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007260
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Iwate Medical University
Division of Gastroenterology and Hepatology, Department of Internal Medicine, School 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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008568

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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