Exercise Training Decreases Alcohol Consumption and Tissue Injury by an FGF21-dependent Mechanism
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
This randomized study will examine whether a 12-week supervised home-based endurance exercise program can reduce alcohol use and alcohol craving in adults with alcohol use disorder (AUD) and alcohol-related liver disease (ALD). Thirty participants will be assigned in a 1:1 ratio to endurance exercise plus standard of care or standard of care alone. Participants in the exercise group will cycle at home three days per week for approximately 60 minutes per session with remote supervision. The study will also evaluate effects of exercise on FGF21, liver injury markers, exercise capacity, physical function, body composition, fatigue, skeletal muscle and mitochondrial function, and exploratory molecular and microbiome measures. The investigators hypothesize that endurance exercise will reduce alcohol use and craving while improving liver and skeletal muscle outcomes, potentially through an FGF21-related mechanism.
Sponsor: The Cleveland Clinic
You may qualify if…
- ✓ • Adults age 18 years or older, of either sex.
- ✓ Clinical diagnosis of alcohol use disorder (AUD) / alcohol-related liver disease (ALD).
- ✓ Meets NIAAA hazardous-drinking criteria: at least 7 drinks/week for women or 14 drinks/week for men for more than 6 months, with ongoing alcohol use within 2 months of evaluation.
- ✓ MELD score less than 21.
- ✓ Able to safely participate in exercise testing and endurance exercise.
- ✓ Able to provide informed consent.
- ✓ No concurrent renal, cardiac, pulmonary, cerebrovascular, or malignant illness that affects skeletal muscle mass; no diabetes mellitus; and no use of medications that affect skeletal muscle mass/protein turnover as described in the protocol, including anabolic steroids, high-dose corticosteroids, or anticoagulants.
You may not qualify if…
- ✕ • Pedal edema above the ankle or grade 2 pedal edema.
- ✕ Liver transplant.
- ✕ Active malignancy.
- ✕ Gastrointestinal bleed within the previous 4 weeks.
- ✕ Hepatic encephalopathy within the previous 6 months.
- ✕ Grade 2 or greater active esophageal varices.
- ✕ Active infection.
- ✕ Large ascites by clinical and/or imaging criteria.
Where it's recruiting
Cleveland
Source: ClinicalTrials.gov · NCT07824089 · last updated 2026-09-17