Pilot trials of oral betaine in participants with metabolic dysfunction-associated steatotic liver disease and elevated alanine aminotransferase

Lim AS, Cruz SN, Uddin AA, et al. · Hepatology

The dose-finding follow-up to the failed 20 g trial: ALT, AST, cytokeratin 18, pro-C3 and the MASEF fibrosis score all fell significantly at 8, 4 and 2 g/day but not at 1 g/day, and LDL cholesterol did not change at these doses. About 35% reported mild transient gastrointestinal symptoms.

Population

Adults with non-cirrhotic metabolic dysfunction-associated steatotic liver disease and ALT at or above 50 U/L, across three pilot trials

Intervention

Betaine 8, 4, 2 or 1 g/day for 12-24 weeks

Comparator

Randomised dose comparison (4 vs 8 g) and within-subject baseline comparison at 2 and 1 g

Limitations

Three small pilot trials; the 1 g and 2 g arms had no placebo group and were compared with their own baselines; serologic markers rather than biopsy; nothing measured in joints.