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

JRCT ID: jRCT1030210391

Registered date:27/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: NAFLD/NASH
• Date of first enrollment: 27/10/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Low-protein diet for 2 weeks

Outcome(s)

• Primary Outcome: Safety assessments including hypotrophic status (nutritional assessment SGA, blood albumin level, total lymphocyte count, free fatty acids) and sarcopenia (sarcopenia screening items).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Nagayama Manabu