UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019598 |
|---|---|
| Receipt number | R000022653 |
| Scientific Title | Effect of Leucine-rich essential amino acid mixture food (amino care jelly Leucine 40) on exercise therapy in NAFLD (Pilot Trial) |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2018/02/01 10:48:29 |
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Basic information
Public title
Effect of Leucine-rich essential amino acid mixture food (amino care jelly Leucine 40) on exercise therapy in NAFLD (Pilot Trial)
Acronym
Amino L40 Trial
Scientific Title
Effect of Leucine-rich essential amino acid mixture food (amino care jelly Leucine 40) on exercise therapy in NAFLD (Pilot Trial)
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yuichiro Eguchi |
Organization
Faculty of Medicine, Saga University
Division name
Division of Hepatology
Zip code
Address
5-1-1 Nabeshima,Saga City, Saga Prefecture, Japan
TEL
0952-34-2362
eguchiyu@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirokazu Takahashi |
Organization
Faculty of Medicine, Saga University
Division name
Department of Internal Medicine
Zip code
Address
5-1-1 Nabeshima,Saga City, Saga Prefecture, Japan
TEL
0952-34-2362
Homepage URL
takahas2@cc.saga-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Saga University
Institute
Department
Personal name
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.
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
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 09 | Month | 11 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022653
