UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042609 |
|---|---|
| Receipt number | R000048618 |
| Scientific Title | A study on the safety of a low-protein diet for patients with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH) |
| Date of disclosure of the study information | 2021/01/01 |
| Last modified on | 2021/07/19 14:27:18 |
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Basic information
Public title
A study on the safety of a low-protein diet for patients with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH)
Acronym
A study on the safety of a low-protein diet for patients with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH)
Scientific Title
A study on the safety of a low-protein diet for patients with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH)
Scientific Title:Acronym
A study on the safety of a low-protein diet for patients with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH)
Region
| Japan |
Condition
Condition
Patients with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety of a low-protein diet for patients with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety assessments including hypotrophic status (nutritional assessment SGA, blood albumin level, total lymphocyte count, free fatty acids) and sarcopenia (sarcopenia screening items).
Key secondary outcomes
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 |
Interventions/Control_1
Low-protein diet for 2 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with liver damage (ALT 40 U/L or higher) due to nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH)
BMI 25 or higher
CAP value 248 db/m or higher at the first FibroScan
Key exclusion criteria
Sarcopenia (AWGS2019)
Liver cirrhosis, alcoholic liver damage, autoimmune hepatitis, primary cholangitis, viral hepatitis, Wilson disease, and other liver diseases
Severe heart failure, diabetes mellitus, hypertension, interstitial pneumonitis, renal failure, autoimmune diseases, and infections
Insulin or steroids use, under hemodialysis
Malignant diseases
Under other dietary intervention
Pregnancy
Others
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Nagayama |
Organization
Jichi Medical University
Division name
Department of Medicine, Division of Gastroenterology
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7348
nagayama@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Nagayama |
Organization
Jichi Medical University
Division name
Department of Medicine, Division of Gastroenterology
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7348
Homepage URL
nagayama@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Keio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
Tel
0285-58-8960
rinri@jichi.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 12 | Month | 01 | Day |
Last modified on
| 2021 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048618
| 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 |
