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

Conditions

• Alcohol Related Liver Disease
• Alcohol Use Disorder (AUD)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

First listed

Sep 17, 2026

Start date

Oct 25, 2026

Status verified

Sep 2026

Primary completion

Dec 31, 2031

Completion

Dec 31, 2031

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Endurance Exercise
  Participants will receive standard of care and complete a 12-week supervised home-based endurance exercise program using a recumbent exercise bike.
• No Intervention: Standard of Care
  Participants will continue usual clinical care and their current pattern of physical activity and will not participate in the structured endurance exercise intervention

Primary Outcome Measure

Change in Alcohol Consumption Measured by Timeline Follow Back (TLFB) [ Time Frame: Baseline to 12 weeks ]

Central Contacts

• Annette Bellar, PhD
  216-445-6268
  [email protected]
• Research Coordinator
  216-445-6268

Locations (1)

Find similar trials in Cleveland, OH

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