Alcohol-associated Fatty Liver DiseasePhase 1/2NCT07897981
High-Plant-Protein-Diet or High-Animal-Protein-Diet for Improving Alcoholic Fatty Liver Disease
A Phase 1/2 study testing whey protein powder and soy protein powder in people with Alcohol-associated Fatty Liver Disease, run by Li Lab,MD at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Alcohol-associated Fatty Liver Disease
- What is being tested?
- whey protein powder and soy protein powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2026to 31 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 74 years old.
- Able to understand the study and voluntarily sign the informed consent form.
- 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%).
Who cannot join
- Average daily ethanol intake >80 g/d.
- Presence of other hepatobiliary diseases, such as autoimmune liver disease, viral hepatitis, liver fibrosis, or cirrhosis.
- Presence of severe cardiovascular or cerebrovascular diseases, or renal insufficiency.
- Patients with tumors or other severe systemic diseases.
- Patients with gastrointestinal disorders, or those with known protein allergy or intolerance.
- Long-term use of medications known to cause hepatic steatosis or steatohepatitis (e.g., amiodarone or tamoxifen), nutritional supplements, or probiotics.
- Total daily energy intake (excluding energy from alcohol) <1900 kcal or ≥2900 kcal.
- Participation in another interventional study within the past year, or scheduled to receive non-study treatments during the trial period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Chinese Medical University
Hangzhou, None Selected, 310053
Songtao Li, +8618989487582, lisongtao@zcmu.edu.cn
About this study
Official title: Efficacy and Safety of a High-Plant-Protein-Diet or High-Animal-Protein-Diet in Patients With Alcoholic Fatty Liver Disease: A Randomized Controlled Trial
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.
- Conditions
- Alcohol-associated Fatty Liver Disease
- Being tested
- whey protein powder, soy protein powder
- Keywords
- alcohol-associated fatty liver disease（AFLD）, high-animal-protein-diet, high-plant-protein-diet, Intrahepatic lipid (IHL), liver iron concentration (LIC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whey protein powderDietary supplement
In addition to following the baseline diet, participants received daily supplementation with animal-based protein isolate powder.
soy protein powderDietary supplement
In addition to following the baseline diet, participants received daily supplementation with plant-based protein isolate powder.
| Study group | Role | What they receive |
|---|---|---|
| high animal protein diet group | Experimental | In addition to the baseline diet, participants received daily supplementation with plant-based protein isolate powder. Receives: Dietary Supplement: whey protein powder |
| high plant protein diet group | Experimental | In addition to the baseline diet, participants received daily supplementation with animal-based protein isolate powder. Receives: Dietary Supplement: soy protein powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrahepatic lipid (IHL)
IHL content was assessed by MRI using a 3.0-T scanner
Measured: Baseline, up to 60 days of the study
Secondary outcomes (9)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline, up to 60 days of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start10 Oct 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alcohol-associated Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: high animal protein diet group Group 2: high plant protein diet group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Lab,MD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Li Lab,MD, Zhejiang Chinese Medical University
- Investigators
- Songtao Li, Study chair, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897981
- Sponsor's protocol ID
- HPPD-HAPD-AFLD-RCT
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protect volunteers' personal health data and personal privacy
Publications
Mackowiak B, Fu Y, Maccioni L, Gao B. Alcohol-associated liver disease. J Clin Invest. 2024 Feb 1;134(3):e176345. doi: 10.1172/JCI176345.
PubMed 38299591Markova M, Pivovarova O, Hornemann S, Sucher S, Frahnow T, Wegner K, Machann J, Petzke KJ, Hierholzer J, Lichtinghagen R, Herder C, Carstensen-Kirberg M, Roden M, Rudovich N, Klaus S, Thomann R, Schneeweiss R, Rohn S, Pfeiffer AF. Isocaloric Diets High in Animal or Plant Protein Reduce Liver Fat and Inflammation in Individuals With Type 2 Diabetes. Gastroenterology. 2017 Feb;152(3):571-585.e8. doi: 10.1053/j.gastro.2016.10.007. Epub 2016 Oct 17.
PubMed 27765690Skytte MJ, Samkani A, Petersen AD, Thomsen MN, Astrup A, Chabanova E, Frystyk J, Holst JJ, Thomsen HS, Madsbad S, Larsen TM, Haugaard SB, Krarup T. A carbohydrate-reduced high-protein diet improves HbA1c and liver fat content in weight stable participants with type 2 diabetes: a randomised controlled trial. Diabetologia. 2019 Nov;62(11):2066-2078. doi: 10.1007/s00125-019-4956-4. Epub 2019 Jul 23.
PubMed 31338545Xu C, Markova M, Seebeck N, Loft A, Hornemann S, Gantert T, Kabisch S, Herz K, Loske J, Ost M, Coleman V, Klauschen F, Rosenthal A, Lange V, Machann J, Klaus S, Grune T, Herzig S, Pivovarova-Ramich O, Pfeiffer AFH. High-protein diet more effectively reduces hepatic fat than low-protein diet despite lower autophagy and FGF21 levels. Liver Int. 2020 Dec;40(12):2982-2997. doi: 10.1111/liv.14596. Epub 2020 Jul 21.
PubMed 32652799Sun P, Huang L, Shuai P, Wan Z, Liu Y, Xue J, Liu Y. Effect of a High Protein, Low Glycemic Index Dietary Intervention on Metabolic Dysfunction-Associated Fatty Liver Disease: A Randomized Controlled Trial. Front Nutr. 2022 Apr 27;9:863834. doi: 10.3389/fnut.2022.863834. eCollection 2022.
PubMed 35571881Papakonstantinou E, Triantafillidou D, Panagiotakos DB, Koutsovasilis A, Saliaris M, Manolis A, Melidonis A, Zampelas A. A high-protein low-fat diet is more effective in improving blood pressure and triglycerides in calorie-restricted obese individuals with newly diagnosed type 2 diabetes. Eur J Clin Nutr. 2010 Jun;64(6):595-602. doi: 10.1038/ejcn.2010.29. Epub 2010 Mar 10.
PubMed 20216558Marin-Alejandre BA, Abete I, Cantero I, Monreal JI, Elorz M, Herrero JI, Benito-Boillos A, Quiroga J, Martinez-Echeverria A, Uriz-Otano JI, Huarte-Muniesa MP, Tur JA, Martinez JA, Zulet MA. The Metabolic and Hepatic Impact of Two Personalized Dietary Strategies in Subjects with Obesity and Nonalcoholic Fatty Liver Disease: The Fatty Liver in Obesity (FLiO) Randomized Controlled Trial. Nutrients. 2019 Oct 22;11(10):2543. doi: 10.3390/nu11102543.
PubMed 31652512
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a High-Plant-Protein-Diet or High-Animal-Protein-Diet in Patients With Alcoholic Fatty Liver Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07897981
- Acronym / sponsor ID
- HPPD-HAPD-AFLD-RCT
- Conditions
- Alcohol-associated Fatty Liver Disease
- Keywords
- alcohol-associated fatty liver disease（AFLD）, high-animal-protein-diet, high-plant-protein-diet, Intrahepatic lipid (IHL), liver iron concentration (LIC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Li Lab,MDOther government
- Study start
- 10 Oct 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1: high animal protein diet group Group 2: high plant protein diet group
| Arm | Type | Receives |
|---|---|---|
| high animal protein diet group | Experimental | Dietary Supplement: whey protein powderIn addition to the baseline diet, participants received daily supplementation with plant-based protein isolate powder. |
| high plant protein diet group | Experimental | Dietary Supplement: soy protein powderIn addition to the baseline diet, participants received daily supplementation with animal-based protein isolate powder. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 and 74 years old.
- Able to understand the study and voluntarily sign the informed consent form.
- 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%).
Key exclusion criteria (8 listed)
- Average daily ethanol intake >80 g/d.
- Presence of other hepatobiliary diseases, such as autoimmune liver disease, viral hepatitis, liver fibrosis, or cirrhosis.
- Presence of severe cardiovascular or cerebrovascular diseases, or renal insufficiency.
- Patients with tumors or other severe systemic diseases.
- Patients with gastrointestinal disorders, or those with known protein allergy or intolerance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whey protein powderIn addition to following the baseline diet, participants received daily supplementation with animal-based protein isolate powder. | Dietary supplement | high animal protein diet group |
| soy protein powderIn addition to following the baseline diet, participants received daily supplementation with plant-based protein isolate powder. | Dietary supplement | high plant protein diet group |
Primary outcome
Intrahepatic lipid (IHL)
Time frame: Baseline, up to 60 days of the study
IHL content was assessed by MRI using a 3.0-T scanner
9 secondary outcomes
alanine aminotransferase (ALT, U/L)
Time frame: Baseline, up to 60 days of the study
γ-glutamyltransferase (GGT, U/L)
Time frame: Baseline, up to 60 days of the study
aspartate aminotransferase (AST, U/L)
Time frame: Baseline, up to 60 days of the study
Hemoglobin A1c (HbA1c, %)
Time frame: Baseline, up to 60 days of the study
Fasting blood glucose (FBG, mmol/L)
Time frame: Baseline, up to 60 days of the study
serum triglycerides (TG, mmol/L)
Time frame: Baseline, up to 60 days of the study
total cholesterol (TC, mmol/L)
Time frame: Baseline, up to 60 days of the study
low-density lipoprotein cholesterol (LDL-C, mmol/L)
Time frame: Baseline, up to 60 days of the study
high-density lipoprotein cholesterol (HDL-C, mmol/L)
Time frame: Baseline, up to 60 days of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publication: PubMed 38299591Mackowiak B, Fu Y, Maccioni L, Gao B. Alcohol-associated liver disease. J Clin Invest. 2024 Feb 1;134(3):e176345. doi: 10.1172/JCI176345.
- Results publication: PubMed 27765690Markova M, Pivovarova O, Hornemann S, Sucher S, Frahnow T, Wegner K, Machann J, Petzke KJ, Hierholzer J, Lichtinghagen R, Herder C, Carstensen-Kirberg M, Roden M, Rudovich N, Klaus S, Thomann R, Schneeweiss R, Rohn S, Pfeiffer AF. Isocaloric Diets High in Animal or Plant Protein Reduce Liver Fat and Inflammation in Individuals With Type 2 Diabetes. Gastroenterology. 2017 Feb;152(3):571-585.e8. doi: 10.1053/j.gastro.2016.10.007. Epub 2016 Oct 17.
- Results publication: PubMed 31338545Skytte MJ, Samkani A, Petersen AD, Thomsen MN, Astrup A, Chabanova E, Frystyk J, Holst JJ, Thomsen HS, Madsbad S, Larsen TM, Haugaard SB, Krarup T. A carbohydrate-reduced high-protein diet improves HbA1c and liver fat content in weight stable participants with type 2 diabetes: a randomised controlled trial. Diabetologia. 2019 Nov;62(11):2066-2078. doi: 10.1007/s00125-019-4956-4. Epub 2019 Jul 23.
- Results publication: PubMed 32652799Xu C, Markova M, Seebeck N, Loft A, Hornemann S, Gantert T, Kabisch S, Herz K, Loske J, Ost M, Coleman V, Klauschen F, Rosenthal A, Lange V, Machann J, Klaus S, Grune T, Herzig S, Pivovarova-Ramich O, Pfeiffer AFH. High-protein diet more effectively reduces hepatic fat than low-protein diet despite lower autophagy and FGF21 levels. Liver Int. 2020 Dec;40(12):2982-2997. doi: 10.1111/liv.14596. Epub 2020 Jul 21.
- Results publication: PubMed 35571881Sun P, Huang L, Shuai P, Wan Z, Liu Y, Xue J, Liu Y. Effect of a High Protein, Low Glycemic Index Dietary Intervention on Metabolic Dysfunction-Associated Fatty Liver Disease: A Randomized Controlled Trial. Front Nutr. 2022 Apr 27;9:863834. doi: 10.3389/fnut.2022.863834. eCollection 2022.
- Results publication: PubMed 20216558Papakonstantinou E, Triantafillidou D, Panagiotakos DB, Koutsovasilis A, Saliaris M, Manolis A, Melidonis A, Zampelas A. A high-protein low-fat diet is more effective in improving blood pressure and triglycerides in calorie-restricted obese individuals with newly diagnosed type 2 diabetes. Eur J Clin Nutr. 2010 Jun;64(6):595-602. doi: 10.1038/ejcn.2010.29. Epub 2010 Mar 10.
- Results publication: PubMed 31652512Marin-Alejandre BA, Abete I, Cantero I, Monreal JI, Elorz M, Herrero JI, Benito-Boillos A, Quiroga J, Martinez-Echeverria A, Uriz-Otano JI, Huarte-Muniesa MP, Tur JA, Martinez JA, Zulet MA. The Metabolic and Hepatic Impact of Two Personalized Dietary Strategies in Subjects with Obesity and Nonalcoholic Fatty Liver Disease: The Fatty Liver in Obesity (FLiO) Randomized Controlled Trial. Nutrients. 2019 Oct 22;11(10):2543. doi: 10.3390/nu11102543.
- Individual participant dataSharing planned: No. Protect volunteers' personal health data and personal privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Songtao Li study chair
Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing whey protein powder and soy protein powder in people with Alcohol-associated Fatty Liver Disease, run by Li Lab,MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingling Huang (+8615267148306, hqingling0306@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrahepatic lipid (IHL) (time frame: Baseline, up to 60 days of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07897981, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.