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Exercise Training Decreases Alcohol Consumption and Tissue Injury by an FGF21-dependent Mechanism

Sponsor: The Cleveland Clinic • ClinicalTrials.gov ID: NCT07824089

Registry updated: 2026-09-17

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Description

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.

Interventions

Endurance Exercise (Behavioral)
Stationary/recumbent cycling three days per week for approximately 60 minutes per session for 12 weeks. Exercise intensity is targeted at approximately 60-70% heart rate reserve and adjusted for safety, tolerance, and beta-blocker use. Sessions are remotely monitored by the study team. Participants who cannot exercise continuously may use rest breaks and complete the prescribed exercise within the limits described in the protocol.

Eligibility criteria

Inclusion Criteria: * • 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. Exclusion Criteria: * • 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. * Advanced cardiac disease (NYHA class 3 or 4) or advanced pulmonary disease (GOLD class 3 or 4). * Use of medications affecting muscle protein turnover, including corticosteroids, or medications used to prevent clotting. * Prior orthopedic surgery or chronic joint pain that, in the opinion of the PI, may inhibit participation. * INR greater than 1.7 or platelet count less than 60,000/mL. * Unable to provide informed consent; judged likely to be unable to perform exercise or unlikely to complete the study in the opinion of the investigators. * End-stage kidney disease defined as eGFR less than 15 mL/min/1.73 m² or dialysis. * Considered unsafe for exercise in the opinion of the PI. * Failure to pass the exercise stress test.

Conditions

Alcohol Use Disorder (AUD) Alcohol Related Liver Disease

Locations

Cleveland Clinic — Cleveland, Ohio, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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