A Phase 1/2 interventional study of whey protein powder and soy protein powder in Alcohol-associated Fatty Liver Disease, sponsored by Li Lab,MD. Recruiting at 1 site in China. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Li Lab,MD · Phase 1/2, Interventional, and Treatment
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 abstinence is often difficult to achieve among individuals with alcohol dependence. Dietary protein source may independently influence metabolic health beyond total protein intake. Plant proteins (primarily derived from legumes and cereals) are rich in arginine, glutamine, and fiber-associated bioactive compounds, whereas animal proteins (mainly from dairy and poultry) are abundant in branched-chain amino acids (BCAAs) and sulfur-containing amino acids. Preclinical studies have demonstrated that, compared with animal proteins such as casein, plant proteins more effectively attenuate high-fat- or alcohol-induced hepatic steatosis by upregulating hepatic PPAR-α expression and suppressing SREBP-1c activity. Human intervention studies further suggest that long-term higher intake of plant protein is associated with lower hepatic fat content and reduced risk of insulin resistance. However, no randomized controlled trial has yet directly compared the effects of high-purity plant protein versus animal protein supplementation on clinical outcomes in patients with AFLD under isocaloric and isonitrogenous conditions. Therefore, this study aims to conduct a randomized controlled trial to evaluate the effects of plant protein versus animal protein supplementation within an isocaloric dietary framework on liver function, hepatic fat content, and glucose-lipid metabolism in individuals with AFLD. The findings will elucidate the efficacy and underlying mechanisms of protein-source modulation in ameliorating AFLD, thereby providing population-based evidence and strategic guidance for health promotion in this patient population.
662 studies on the registry are indexed under Fatty Liver; 184 are open to participants now.
This study's planned enrollment of 74 is above the median of 60 across 431 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →Li Lab,MD is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In addition to the baseline diet, participants received daily supplementation with plant-based protein isolate powder.
Dietary Supplement: whey protein powder
In addition to the baseline diet, participants received daily supplementation with animal-based protein isolate powder.
Dietary Supplement: soy protein powder
In addition to following the baseline diet, participants received daily supplementation with animal-based protein isolate powder.
In addition to following the baseline diet, participants received daily supplementation with plant-based protein isolate powder.
Intrahepatic lipid (IHL)
IHL content was assessed by MRI using a 3.0-T scanner
Time frame: Baseline, up to 60 days of the study
alanine aminotransferase (ALT, U/L)
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. AST was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Time frame: Baseline, up to 60 days of the study
γ-glutamyltransferase (GGT, U/L)
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. GGT was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Time frame: Baseline, up to 60 days of the study
aspartate aminotransferase (AST, U/L)
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. AST was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Time frame: Baseline, up to 60 days of the study
Hemoglobin A1c (HbA1c, %)
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. HbA1c was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Time frame: Baseline, up to 60 days of the study
Fasting blood glucose (FBG, mmol/L)
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. FBG was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Time frame: Baseline, up to 60 days of the study
serum triglycerides (TG, mmol/L)
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. TG was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Time frame: Baseline, up to 60 days of the study
total cholesterol (TC, mmol/L)
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. TC was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Time frame: Baseline, up to 60 days of the study
low-density lipoprotein cholesterol (LDL-C, mmol/L)
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. LDL-C was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Time frame: Baseline, up to 60 days of the study
high-density lipoprotein cholesterol (HDL-C, mmol/L)
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. HDL-C was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Time frame: Baseline, up to 60 days of the study
Tumor necrosis factor (TNF-α, pg/mL)
Serum TNF-α was performed using a cytometric bead array (CBA) method with a commercially available human inflammatory cytokine kit (BD Biosciences, Heidelberg, Germany).
Time frame: Baseline, up to 60 days of the study
interleukins (IL-1β, pg/mL)
Serum IL-1β was performed using a cytometric bead array (CBA) method with a commercially available human inflammatory cytokine kit (BD Biosciences, Heidelberg, Germany).
Time frame: Baseline, up to 60 days of the study
Blood creatinine (CREA, μmol/L)
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. CREA was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Time frame: Baseline, up to 60 days of the study
urea nitrogen (BUN, mmol/L)
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. BUN was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Time frame: Baseline, up to 60 days of the study
Intestinal flora
16s rRNA sequencing
Time frame: Baseline, up to 60 days of the study
serum untargeted metabolomics
Serum untargeted metabolomics was performed using a Vanquish UHPLC system coupled to an Orbitrap Exploris 120 mass spectrometer (Thermo Fisher Scientific, USA)
Time frame: Baseline, up to 60 days of the study
Plan to share: No — Protect volunteers' personal health data and personal privacy
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Whey Protein Isolate · Soybean Proteins
Li Lab,MD