UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Leucine-rich essential amino acid mixture food (amino care jelly Leucine 40) on exercise therapy in NAFLD (Pilot Trial)
Title of the study (Brief title)	Amino L40 Trial
Region	Japan

Condition
Condition	Non-alcoholic fatty liver disease
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This pilot trial aims to evaluate of effect of intake of "amino care jelly Leucine 40" after exercise therapy on improvements in skeletal muscle tissue fat accumulation and glucose metabolism in NAFLD
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Longitudinal change in skeletal muscle tissue fat accumulation by IMAC
Key secondary outcomes	Skeletal muscle volume, insulin resistance, liver function, serum lipid, glucose metabolism, inflammatory markers, and each parameter

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	(1) Diet and exercise therapy (+) amino care jelly Leucine 40 (-) 0 - 12 weeks (2) Diet and exercise therapy (+) amino care jelly Leucine 40 (100g / day) (+) 12 - 24 weeks
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	50 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Cases were clinically diagnosed as NAFLD (2) More than 50 years of age and less than 80 years (3) Informed consent is obtained by sentence
Key exclusion criteria	(1) Patients with viral hepatitis (2) Liver cirrhosis patients (3) Patients with malignant tumor (not included after radical) (4) Individuals with a history of cardiovascular or cerebrovascular Diseases (5) Severe liver disease (6) Severe renal disease (7) Patients with rush by "amino care jelly Leucine 40"
Target sample size	20

Research contact person
Name of lead principal investigator	Yuichiro Eguchi
Organization	Faculty of Medicine, Saga University
Division name	Division of Hepatology
Address	5-1-1 Nabeshima,Saga City, Saga Prefecture, Japan
TEL	0952-34-2362
Email	eguchiyu@cc.saga-u.ac.jp

Public contact
Name of contact person	Hirokazu Takahashi
Organization	Faculty of Medicine, Saga University
Division name	Department of Internal Medicine
Address	5-1-1 Nabeshima,Saga City, Saga Prefecture, Japan
TEL	0952-34-2362
Homepage URL
Email	takahas2@cc.saga-u.ac.jp

Sponsor
Institute	Faculty of Medicine, Saga University
Institute
Department

Funding Source
Organization	Faculty of Medicine, Saga University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Eguchi Hospital
Name of secondary funｄer(s)	Ajinomoto Co.,Ltd.

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	佐賀大学医学部（佐賀県）

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 09 Month 11 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
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	2015 Year 11 Month 02 Day
Last modified on	2018 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022653