Can a High-Protein diet reverse fatty liver from alcohol?
NCT ID NCT07632222
First seen Jun 25, 2026 · Last updated Jun 30, 2026 · Updated 3 times
Summary
This phase 2 trial tests whether a high-protein diet (30% protein, 40% carbs, 30% fat) can reduce liver fat and improve liver function in 72 adults with alcoholic fatty liver disease. Participants will be randomly assigned to either the high-protein diet or a standard diet for 6 weeks. The main goal is to measure changes in liver fat using MRI, along with other markers of liver health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- high-protein diet (30% protein, 40% carbohydrates, 30% fat)
- What this could lead to
- If it works, this could point toward a simple dietary strategy to reduce liver fat and improve liver health in people with alcoholic fatty liver disease.
- What could go wrong
- This is a small, early-phase trial with only 72 participants. The diet may be hard to follow long-term, and results may not apply to everyone. No serious risks are expected, but the benefit is uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jul 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
30 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged between 30 and 65 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Alcohol-associated fatty liver disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.