Plant or animal protein diet in alcoholic fatty liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares the effects of two protein-rich diets on alcohol-associated fatty liver disease. Participants will receive either whey or soy protein powder as part of a dietary plan and will be followed to assess liver fat and related health markers. The trial includes adults with AFLD who consume alcohol and meet diagnostic criteria, with exclusions for other liver diseases and major health conditions. The study is conducted in Zhejiang, China, and is sponsored by Li Lab, MD. Outcomes will inform whether protein source influences intrahepatic lipid and liver-related measures in AFLD.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhejiang Chinese Medical University
  Hangzhou, None Selected, China Recruiting

Study contacts

• Study coordinator: Qingling Huang
• Email: hqingling0306@163.com
• Phone: +8615267148306

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Glucagon resistance in MASLD and type 2 diabetes

  This will see if people with type 2 diabetes, with or without MASLD, respond differently to glucagon in liver fat oxidation and VLDL-triglyceride secretion.

  Recruiting University of Aarhus · Aarhus · NCT07246421

• Rifaximin treatment for metabolic-associated fatty liver disease

  This trial tests whether taking oral rifaximin for 24 weeks helps adults with metabolic-associated fatty liver disease (MAFLD) and is safe.

  Recruiting Early Phase 1 Shanghai Changzheng Hospital · Shanghai, Shanghai Municipality · NCT07185932

• New MRI methods to measure metabolism and predict outcomes in metabolic-associated fatty liver disease

  This project tests whether new MRI techniques can measure body metabolism and help predict disease status and prognosis for people with metabolic-associated fatty liver disease.

  Recruiting Tongji Hospital · Wuhan, Hubei · NCT07149571

• Non-invasive blood and imaging tests for metabolic liver disease

  This project tests whether blood tests and imaging scans can diagnose and stage metabolic-associated steatohepatitis (MASH) and liver fibrosis in adults with metabolic risk factors.

  Recruiting at 4 sites Foundation for the National Institutes of Health · Miami, Florida and 3 other locations · NCT07122700

• Effects of a Low Valine Diet on Weight and Metabolism

  This study is testing if meal replacements with less valine can help overweight and obese people lose weight and improve their metabolism compared to regular meal replacements.

  Recruiting Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT06883578

• Investigating the prevalence of metabolic associated fatty liver disease in patients with type 2 diabetes in Jiangsu Province, China

  This study looks at how common fatty liver disease is in people with type 2 diabetes in Jiangsu Province, China, and how it relates to their insulin levels.

  Recruiting Wuxi Hisky Medical Technology Co Ltd · Nanjing, Jiangsu · NCT05597709

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.