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

Phase 1

Recruiting

• Conditions: AFLD/NASH; D065626

• Registration Number: JPRN-jRCT1030210391
• Lead Sponsor: agayama Manabu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified