UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019131 |
|---|---|
| Receipt number | R000022118 |
| Scientific Title | Effect of the medical walking and leucine enriched amino acid containing food for non-alcoholic fatty liver disease : Randomized controled trial |
| Date of disclosure of the study information | 2015/09/27 |
| Last modified on | 2015/10/07 23:40:59 |
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Basic information
Public title
Effect of the medical walking and leucine enriched amino acid containing food for non-alcoholic fatty liver disease : Randomized controled trial
Acronym
Effect of the medical walking and leucine enriched amino acid containing food for NAFLD : Randomized controled trial
Scientific Title
Effect of the medical walking and leucine enriched amino acid containing food for non-alcoholic fatty liver disease : Randomized controled trial
Scientific Title:Acronym
Effect of the medical walking and leucine enriched amino acid containing food for NAFLD : Randomized controled trial
Region
| Japan |
Condition
Condition
Nonalcoholic fatty liver disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify safety and efficacy of medical walking and leucine enriched amino acid containing food for NAFLD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of ALT before the treatment and 12 weeks later
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
medical walking (3 months,8,000 steps / day)
Interventions/Control_2
medical walking (3 months,8,000 steps / day)and leucine enriched amino acid containing food (3 months, 1 pack / day)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)20 years old or older
2)The patients who had a diagnosis of NAFLD or NASH clinically or histologically
3)The ALT within four weeks is 40 IU/l or more
4)Enough informed consent is obtained.
Key exclusion criteria
1)Participant of other clinical trials
2)The patients whom doctors judged to be inadequate as subjects
3)The patients with allergy to apple
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Naganuma |
Organization
Takasaki General Medical Center, National Hospital Organization
Division name
Department of Gastroenterology
Zip code
Address
36 Takamatsu-machi, Takasaki-city, Gunma
TEL
+81273225901
anaganuma@takasaki-hosp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Ozawa |
Organization
Takasaki General Medical Center, National Hospital Organization
Division name
Clinical Research Department
Zip code
Address
36 Takamatsu-machi, Takasaki-city, Gunma
TEL
+81273225901
Homepage URL
tcr-jimu1@takasaki-hosp.jp
Sponsor or person
Institute
Takasaki General Medical Center, National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
Takasaki General Medical Center, National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | 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
| 2015 | Year | 09 | Month | 27 | Day |
Last modified on
| 2015 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022118
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
