UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022730 |
|---|---|
| Receipt number | R000026157 |
| Scientific Title | Research on nutritional therapy for non-alcoholic fatty liver disease. |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2023/12/20 11:15:15 |
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Basic information
Public title
Research on nutritional therapy for non-alcoholic fatty liver disease.
Acronym
Research on nutritional therapy for NAFLD.
Scientific Title
Research on nutritional therapy for non-alcoholic fatty liver disease.
Scientific Title:Acronym
Research on nutritional therapy for NAFLD.
Region
| Japan |
Condition
Condition
non-alcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effective nutritional interventions for Japanese NAFLD patients.
Basic objectives2
Others
Basic objectives -Others
This study assesses the changes of vegetables intake, dietary intake behavior modification and physical status of Japanese individuals with NAFLD by frequent nutritional intervention motivated vegetables intake in addition to general dietary education.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in vegetables intake, body weight, BMI and liver fat in 6 months intervention.
Key secondary outcomes
Change in nutritional intakes, AST, ALT, FIB4 index, behavior modification stage, eating behavior psychology and intestinal flora in 6 months intervention.
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
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Nutritional intervention using teaching materials motivated vegetables intake increase (twice a month), Visits of examination and nutritional guidance (once every three months)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
NAFLD patients
Key exclusion criteria
1) NAFLD stage 4
2) Patients judged by the investigator/ sub investigator to be ineligible for some other reason.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Sumida |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroentroerology and Hepatology
Zip code
602-8566
Address
Kajii-cho, Kamigyo, Kyoto
TEL
075-251-5519
sumida@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Kobayashi |
Organization
Kyoto Prefectural University
Division name
Graduate School of Life and Environmental Sciences
Zip code
6068522
Address
Shimogamo, Sakyo, Kyoto
TEL
075-703-6017
Homepage URL
yukicoba@kpu.ac.jp
Sponsor or person
Institute
Molecular Gastroentroerology and Hepatology, Kyoto Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Life and Environmental Sciences, Kyoto Prefectural University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Life and Environmental Sciences, Kyoto Prefectural University
Address
1-5 Shimogamo-hangicho, Sakyo, Kyoto, Japan
Tel
075-703-6017
yukicoba@kpu.ac.jp
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
京都府立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | 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
15
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
| 2016 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2016 | Year | 06 | Month | 14 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026157
| Research Plan | |
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| 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 |
