UMIN-CTR Clinical Trial

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
Email	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
Email	nagayama@jichi.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048618