UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of a combination of dietary intervention and functional therapy using ingredient analytical instrument in fatty liver patients: a randomized controlled trial.
Title of the study (Brief title)	Dietary and functional intervention study.
Region	Japan

Condition
Condition	fatty liver diseases Non-alcoholic Fatty Liver Diseases Non-alcoholic steatohepatitis
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Non-alcoholic fatty liver disease (NAFLD) and a nonalcoholic steatohepatitis (NASH) is required management of diet, and recommended to do a continued exercise. Purpose of this study is to explore the efficacy of the multidisciplinary team approach to support diet therapy accompanying nutritional guidance and exercise instruction accompanying exercise instruction together.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Changes from baseline of skeletal muscle mass; body fat mass; basal metabolism rate; and visceral fat area, at one, two, three, six, nine, and 12 months after the start of the intervention.
Key secondary outcomes	Motor function test (6 minutes walking distance, grip strength,Knee extension muscle strength), blood biochemical test (AST,ALT, GTP, TG,HDL-cho LDL-cho, BS, insulin, iron, ferritin, FFA Hyaluronic acid, type IV collagen 7S, etc.), abdominal supersonic Wave test (liver hardness, rate of change of hepatic fat mass).

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Educational intervention
Interventions/Control_2	12 months
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	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patient diagnosed as fatty liver 2. Patient aged over 20 years old and under 75 3. PS 0 - 1 (ECOG) 4. Patient can intake orally 5. Informed Consent has been obtained in writing form.by himself / herself about examination participation
Key exclusion criteria	1. Patient who has been infected with hepatitis virus 2. Patient has a clear drinking history (Alcohol amount: over 20 g / day) 3. patient who has difficulties in doing exercise, such as any joint pain, kidney dysfunction or heart disease 4. Patient who has poorly controlled diabetes 5. Patient who was judged as inappropriate for this research by physichans.
Target sample size	26

Research contact person
Name of lead principal investigator	Masashi FURUTA
Organization	National Center for Global Health and Medicine
Division name	The Research Center for Hepatitis and Immunology
Address	1-7-1 Kohnodai, Ichikawa-City, Chiba, Japan
TEL	047-372-3501
Email	masashi.furuta@med.toho-u.ac.jp

Public contact
Name of contact person	Masashi FURUTA
Organization	National Center for Global Health and Medicine
Division name	The Research Center for Hepatitis and Immunology
Address	1-7-1 Kohnodai, Ichikawa-City, Chiba, Japan
TEL	047-372-3501
Homepage URL
Email	masashi.furuta@med.toho-u.ac.jp

Sponsor
Institute	National Center for Global Health and Medicine The Research Center for Hepatitis and Immunology Department of Liver Disease
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	国立国際医療研究センター国府台病院(千葉県） National Center for Global Health and Medicine　Konodai　Hospital

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 22 Day
Anticipated trial start date	2014 Year 05 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 06 Day
Last modified on	2018 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034018