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High-Plant-Protein-Diet or High-Animal-Protein-Diet for Improving Alcoholic Fatty Liver Disease

RecruitingPhase 1, Phase 2Ages 18 Years - 74 YearsAllLi Lab,MD
NCT07897981 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Alcohol-associated liver disease (ALD) is a major cause of mortality from advanced liver disease, accounting for 47.9% of cirrhosis-related deaths and 30% of hepatocellular carcinoma-related deaths annually. In China, both per capita alcohol consumption and the prevalence of ALD (approximately 5.15%) are on the rise, making ALD an increasingly significant public health burden. Alcohol-associated fatty liver disease (AFLD), the initial and most reversible stage of ALD, is pathologically characterized by excessive hepatic lipid accumulation, mild hepatocellular injury, and low-grade inflammation. It can progress to alcoholic hepatitis, and in some patients, advance to hepatic fibrosis, cirrhosis, or even hepatocellular carcinoma. Currently, there is no established effective pharmacotherapy for AFLD; although alcohol abstinence remains the optimal strategy for disease reversal, sustained ab

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Aged between 18 and 74 years old. 2. Able to understand the study and voluntarily sign the informed consent form. 3. Meet the clinical diagnostic criteria for alcohol-associated fatty liver disease (AFLD): a history of alcohol consumption for ≥5 years, with an average daily ethanol intake of ≥20 g/d; clinically diagnosed with fatty liver (indicated by abdominal ultrasound or a liver MRI proton density fat fraction \[MRI-PDFF\] ≥5.2%). Exclusion Criteria: 1. Average daily ethanol intake \>80 g/d. 2. Presence of other hepatobiliary diseases, such as autoimmune liver disease, viral hepatitis, liver fibrosis, or cirrhosis. 3. Presence of severe cardiovascular or cerebrovascular diseases, or renal insufficiency. 4. Patients with tumors or other severe systemic diseases. 5. Patients with gastrointestinal disorders, or those with known protein allergy or intolerance. 6. Long-term use of medications known to cause hepatic steatosis or steatohepatitis (e.g., amiodarone or tamoxifen), nutritional supplements, or probiotics. 7. Total daily energy intake (excluding energy from alcohol) \<1900 kcal or ≥2900 kcal. 8. Participation in another interventional study within the past year, or scheduled to receive non-study treatments during the trial period.
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What it tests

  • whey protein powder
  • soy protein powder
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Where

1 site
Zhejiang Chinese Medical University
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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