Garda

Researchers are evaluating the effects of a specific blend of essential amino acids (EAA) on lean body mass (LBM) changes in patients with anorexia nervosa (AN) during weight restoration. The study focuses on patients undergoing intensive inpatient enhanced cognitive behavior therapy (CBT-E) and aims to compare EAA supplementation to placebo. This 13-week randomized, double-blind, placebo-controlled study also investigates weight recovery, physical fitness, eating disorder and general psychopathology, as well as psychosocial impairment. Participants will be randomly assigned to receive either the amino acid supplement Amino-Ther Pro or a placebo (maltodextrin) upon admission to inpatient or day hospital treatment. The treatment includes a structured nutritional rehabilitation protocol targeting weight gain with a goal BMI of 19, alongside two weekly physiotherapist-led calisthenics sessions for patients with BMI above 15. The CBT-E treatment is individualized and delivered in four phases over 13 weeks, focusing on behavioral change, addressing eating disorder maintenance mechanisms, weight maintenance, and preparation for outpatient therapy. After the treatment, participants may continue EAA supplementation for an additional 24 weeks to assess long-term effects. Participants will undergo assessments at baseline and after 13 weeks, measuring lean body mass, body weight, eating disorder symptoms, general psychopathology, and psychosocial functioning. Safety and treatment adherence will be monitored throughout the study. Follow-up evaluations are planned at 24 weeks to observe sustained outcomes. The study is conducted at the Nutritional Rehabilitation Unit of Villa Garda Hospital in Italy, with oversight by expert clinicians and a rigorous informed consent process.