UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020737 |
|---|---|
| Receipt number | R000023927 |
| Scientific Title | To evaluate the effect of customized online nutrition guidance system for treating of patients with NAFLD undergoing diet therapy at home. |
| Date of disclosure of the study information | 2016/01/27 |
| Last modified on | 2016/01/26 14:10:30 |
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Basic information
Public title
To evaluate the effect of customized online nutrition guidance system for treating of patients with NAFLD undergoing diet therapy at home.
Acronym
customized online nutrition guidance system for patients with NAFLD
Scientific Title
To evaluate the effect of customized online nutrition guidance system for treating of patients with NAFLD undergoing diet therapy at home.
Scientific Title:Acronym
customized online nutrition guidance system for patients with NAFLD
Region
| Japan |
Condition
Condition
non-alcoholic fatty liver disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of customized online nutrition guidance system for treating of patients with NAFLD undergoing diet therapy at home.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We evaluate body weight and serum ALT/AST levels before and after this study.
Key secondary outcomes
We evaluate food habits before and after this study.
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The instructors advised the patients by e-mail every 10 days.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with clinically diagnosed non-alcoholic fatty liver disease.
Key exclusion criteria
Patients with other liver diseases
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonori Aoyama |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5802-1060
aoyama@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonori Aoyama |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5802-1060
Homepage URL
aoyama@juntendo.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Hitachi, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
| 2016 | Year | 01 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 26 | Day |
Last modified on
| 2016 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023927
