A study on the safety of a low-protein diet for patients with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1030210391

Enrollment

Registered

2021-10-27

Start date

2021-10-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAFLD/NASH

Interventions

Low-protein diet for 2 weeks

D018753

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Fulfill three criteria below, 1. Patients with liver damage (ALT 40 U/L or higher) due to nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH) 2. BMI 25 or higher 3. CAP value 248 db/m or higher at the first FibroScan

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Safety assessments including hypotrophic status (nutritional assessment SGA, blood albumin level, total lymphocyte count, free fatty acids) and sarcopenia (sarcopenia screening items).	—

Contacts

Public ContactManabu Nagayama

Jichi Medical University

nagayama@jichi.ac.jp+81-285-58-7348

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026