Alcohol-associated Fatty Liver DiseasePhase 1/2HP-AFLD-RCTNCT07632222
High-Protein Diet for Improving Alcoholic Fatty Liver Disease
A Phase 1/2 study testing high protein diet and perilla peptide dietary group in people with Alcohol-associated Fatty Liver Disease, run by Li Lab,MD.
Trial summary
Alcohol-associated liver disease (ALD) is a major cause of mortality from malignant liver diseases, accounting for 47.9% of cirrhosis-related deaths and 30% of liver cancer-related deaths annually. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Alcohol-associated Fatty Liver Disease
- What is being tested?
- high protein diet and perilla peptide dietary group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2027
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 30 and 65 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of a High-Protein Diet Versus a Standard Diet in Patients With Alcoholic Fatty Liver Disease: A Randomized Controlled Trial
Alcohol-associated liver disease (ALD) is a major cause of mortality from malignant liver diseases, accounting for 47.9% of cirrhosis-related deaths and 30% of liver cancer-related deaths annually. In China, both alcohol consumption and the prevalence of ALD (approximately 5.15%) are on the rise, making ALD an increasingly significant health concern for the population. Alcohol-associated fatty liver disease (AFLD), as the initial and most reversible stage of ALD, is primarily characterized by excessive hepatic lipid deposition, mild liver injury accompanied by mild inflammation. It can progressively develop into alcoholic hepatitis, and in some patients, advance to liver fibrosis, cirrhosis, and even hepatocellular carcinoma. Currently, there is a lack of effective clinical treatments for AFLD. Although alcohol abstinence remains the optimal choice for reversing AFLD, it is often difficult for individuals with alcohol dependence to maintain.
A high-protein diet generally refers to a dietary pattern where protein accounts for more than 20% of total energy intake. A protein contribution of 30% is a common ratio in research investigating high-protein dietary interventions for metabolic diseases. Population-based intervention studies have demonstrated that a high-protein diet at this ratio significantly reduces hepatic fat content. For instance, a study published in Gastroenterology (2017) reported that a 6-week isocaloric high-protein diet (macronutrient distribution: 30% protein, 40% carbohydrates, 30% fat) significantly improved hepatic lipid deposition in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes mellitus (T2DM). Research in Diabetologia (2019) showed that a 6-week isocaloric high-protein diet (30% protein, 30% carbohydrates, 40% fat) significantly reduced hepatic fat content in patients with T2DM. Additionally, a study in Liver International (2020) indicated that a 3-week energy-restricted high-protein diet (30% protein, 35%-45% carbohydrates, 25%-30% fat) significantly decreased hepatic fat content in NAFLD patients. Importantly, none of the aforementioned studies reported adverse events associated with the high-protein dietary interventions. Furthermore, a population-based intervention study published in Annals of Internal Medicine revealed that a low-carbohydrate, high-fat diet was more effective than a high-carbohydrate, low-fat diet in reducing hepatic fat content over a 6-month period in patients with NAFLD and T2DM. These findings suggest that increasing the percentage of energy from protein by reducing carbohydrate intake may yield superior improvements. Based on the macronutrient distributions from the referenced population interventions, and considering that a 30% fat energy contribution closely aligns with the typical dietary fat intake of the Chinese AFLD population, we established the macronutrient distribution for the high-protein diet group as 30% protein, 40% carbohydrates, and 30% fat.
This study intends to conduct a randomized controlled trial to investigate the effects of increasing the percentage of energy from protein under an isocaloric dietary pattern on liver function, hepatic fat content, and glucose-lipid metabolism in individuals with AFLD. The aim is to elucidate the mechanisms underlying its beneficial effects on AFLD, thereby providing population-based evidence and strategies for health promotion in this patient group.
- Conditions
- Alcohol-associated Fatty Liver Disease
- Being tested
- high protein diet, control diet, perilla peptide dietary group
- Keywords
- alcohol-associated fatty liver disease（AFLD）, high protein, MRI-PDFF, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high protein dietDietary supplement
high protein diet
control dietDietary supplement
control diet
perilla peptide dietary groupDietary supplement
perilla peptide dietary group
| Study group | Role | What they receive |
|---|---|---|
| high protein diet group | Experimental | Arm Description: High-protein meals will be provided for 6 days per week, and high-protein recipes will be provided for the remainder of the week. Receives: Dietary Supplement: high protein diet |
| control diet group | Placebo comparator | Control meals will be provided for 6 days per week, and control recipes will be provided for the remainder of the week. Receives: Dietary Supplement: control diet |
| perilla peptide dietary group | Experimental | The perilla peptide alternative maintains the same total protein intake by partially replacing conventional protein sources with hydrolyzed vegetable protein. Receives: Dietary Supplement: perilla peptide dietary group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging proton density fat fraction in hepatic steatosis
Magnetic Resonance Imaging (MRI) technology utilizes magnetic fields and radiofrequency pulses to conduct non-invasive examinations of tissues. When measuring liver fat content, MRI employs water-fat separation techniques to quantify the proton density of water molecules and fat molecules (PDFF) within the liver, thereby providing a quantitative analysis of fat content.
Measured: Baseline, up to 60 days of the study
Secondary outcomes (3)
Liver function
Alanine aminotransferase (ALT, U/L), aspartate aminotransferase (AST, U/L), γ-glutamyltransferase (γ-GT, U/L), alkaline phosphatase (ALP, U/L), total bilirubin (TBIL, μmol/L), direct bilirubin (DBIL, μmol/L), indirect bilirubin (IBIL, μmol/L), alcohol dehydrogenase (ADH, U/L), aldehyde dehydrogenase (ALDH, U/L).
Measured: Baseline, up to 60 days of the study
Glucose metabolism
Hemoglobin A1c (HbA1c, %), Fasting blood glucose (FBG, mmol/L)
Measured: Baseline, up to 60 days of the study
Lipid metabolism
Serum triglycerides (TG, mmol/L), total cholesterol (TC, mmol/L), low-density lipoprotein cholesterol (LDL-C, mmol/L), high-density lipoprotein cholesterol (HDL-C, mmol/L), apolipoprotein A-I (ApoA-I, g/L), apolipoprotein B (Apo B, g/L).
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 posted8 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (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
- Intervention Group: high protein diet Intervention Group: perilla peptide dietary group Control Group: control diet
- 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
- Collaborators
- Harbin Medical University
- Responsible party
- Sponsor-investigator, Li Lab,MD, Zhejiang Chinese Medical University
- Investigators
- Songtao Li, Study chair, Zhejiang Chinese Medical UniversityRennan Ren, Study chair, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632222
- Sponsor's protocol ID
- HP-AFLD-RCT
- Acronym
- HP-AFLD-RCT
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 29 Jun 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
Marin-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 31652512Papakonstantinou 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 20216558Sun 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 35571881Xu 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 32652799Skytte 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 31338545Markova 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 27765690Mackowiak 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 38299591
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a High-Protein Diet Versus a Standard Diet in Patients With Alcoholic Fatty Liver Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07632222
- Acronym / sponsor ID
- HP-AFLD-RCT / HP-AFLD-RCT
- Conditions
- Alcohol-associated Fatty Liver Disease
- Keywords
- alcohol-associated fatty liver disease（AFLD）, high protein, MRI-PDFF, RCT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Li Lab,MDOther government
- Collaborators
- Harbin Medical University
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Jun 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 malignant liver diseases, accounting for 47.9% of cirrhosis-related deaths and 30% of liver cancer-related deaths annually. In China, both alcohol consumption and the prevalence of ALD (approximately 5.15%) are on the rise, making ALD an increasingly significant health concern for the population. Alcohol-associated fatty liver disease (AFLD), as the initial and most reversible stage of ALD, is primarily characterized by excessive hepatic lipid deposition, mild liver injury accompanied by mild inflammation. It can progressively develop into alcoholic hepatitis, and in some patients, advance to liver fibrosis, cirrhosis, and even hepatocellular carcinoma. Currently, there is a lack of effective clinical treatments for AFLD. Although alcohol abstinence remains the optimal choice for reversing AFLD, it is often difficult for individuals with alcohol dependence to maintain.
A high-protein diet generally refers to a dietary pattern where protein accounts for more than 20% of total energy intake. A protein contribution of 30% is a common ratio in research investigating high-protein dietary interventions for metabolic diseases. Population-based intervention studies have demonstrated that a high-protein diet at this ratio significantly reduces hepatic fat content. For instance, a study published in Gastroenterology (2017) reported that a 6-week isocaloric high-protein diet (macronutrient distribution: 30% protein, 40% carbohydrates, 30% fat) significantly improved hepatic lipid deposition in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes mellitus (T2DM). Research in Diabetologia (2019) showed that a 6-week isocaloric high-protein diet (30% protein, 30% carbohydrates, 40% fat) significantly reduced hepatic fat content in patients with T2DM. Additionally, a study in Liver International (2020) indicated that a 3-week energy-restricted high-protein diet (30% protein, 35%-45% carbohydrates, 25%-30% fat) significantly decreased hepatic fat content in NAFLD patients. Importantly, none of the aforementioned studies reported adverse events associated with the high-protein dietary interventions. Furthermore, a population-based intervention study published in Annals of Internal Medicine revealed that a low-carbohydrate, high-fat diet was more effective than a high-carbohydrate, low-fat diet in reducing hepatic fat content over a 6-month period in patients with NAFLD and T2DM. These findings suggest that increasing the percentage of energy from protein by reducing carbohydrate intake may yield superior improvements. Based on the macronutrient distributions from the referenced population interventions, and considering that a 30% fat energy contribution closely aligns with the typical dietary fat intake of the Chinese AFLD population, we established the macronutrient distribution for the high-protein diet group as 30% protein, 40% carbohydrates, and 30% fat.
This study intends to conduct a randomized controlled trial to investigate the effects of increasing the percentage of energy from protein under an isocaloric dietary pattern on liver function, hepatic fat content, and glucose-lipid metabolism in individuals with AFLD. The aim is to elucidate the mechanisms underlying its beneficial effects on AFLD, thereby providing population-based evidence and strategies for health promotion in this patient group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Intervention Group: high protein diet Intervention Group: perilla peptide dietary group Control Group: control diet
| Arm | Type | Receives |
|---|---|---|
| high protein diet group | Experimental | Dietary Supplement: high protein dietArm Description: High-protein meals will be provided for 6 days per week, and high-protein recipes will be provided for the remainder of the week. |
| control diet group | Placebo comparator | Dietary Supplement: control dietControl meals will be provided for 6 days per week, and control recipes will be provided for the remainder of the week. |
| perilla peptide dietary group | Experimental | Dietary Supplement: perilla peptide dietary groupThe perilla peptide alternative maintains the same total protein intake by partially replacing conventional protein sources with hydrolyzed vegetable protein. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 30 and 65 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 |
|---|---|---|
| high protein diethigh protein diet | Dietary supplement | high protein diet group |
| control dietcontrol diet | Dietary supplement | control diet group |
| perilla peptide dietary groupperilla peptide dietary group | Dietary supplement | perilla peptide dietary group |
Primary outcome
Magnetic Resonance Imaging proton density fat fraction in hepatic steatosis
Time frame: Baseline, up to 60 days of the study
Magnetic Resonance Imaging (MRI) technology utilizes magnetic fields and radiofrequency pulses to conduct non-invasive examinations of tissues. When measuring liver fat content, MRI employs water-fat separation techniques to quantify the proton density of water molecules and fat molecules (PDFF) within the liver, thereby providing a quantitative analysis of fat content.
3 secondary outcomes
Liver function
Time frame: Baseline, up to 60 days of the study
Glucose metabolism
Time frame: Baseline, up to 60 days of the study
Lipid metabolism
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 29 Jun 2026.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- 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
Rennan Ren study chair
Harbin Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing high protein diet and perilla peptide dietary group in people with Alcohol-associated Fatty Liver Disease, run by Li Lab,MD.
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: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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, Dr. (+8615267148306, hqingling0306@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Imaging proton density fat fraction in hepatic steatosis (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 NCT07632222, 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 29 Jun 2026.