Amino Acids in Patients With Anorexia Nervosa: Double-blind Randomized Study Versus Placebo

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Anorexia Nervosa

In brief

Amino acids (AAs) are crucial for protein synthesis, in influencing nutritional status, as sources of vital elements (e.g., nucleotides, neurotransmitters) and as signal molecules for the modulation of gene expression and epigenetic mechanisms. Data on the role of amino acids in underweight patients with anorexia nervosa (AN) are unknown. This study aims to evaluate whether a blend of essential amino acids (EAA) could influence the change in lean body mass (LBM) in patients with AN during weight restoration, treated with intensive inpatient enhanced cognitive behavior therapy (CBT-E). A total of 92 patients will be randomized to EAA supplementation or placebo supplementation upon admission to inpatient treatment. LBM, but also body weight, specific and general psychopathology, impairment assessment will be assessed at baseline and after 13 weeks of treatment.

Key facts

Study ID

NCT05290285

Run by

Villa Garda Hospital

People needed

92

Starts

2022-07-01

Expected to finish

2027-01-01

Last updated by the study team

2025-09-05

Who can join

Age: 16 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of anorexia nervosa
• Age between 16 and 50 years
• Written informed consent

You may not qualify if…

• Schizophrenia or other psychotic disorders
• Diagnosis of bulimia nervosa
• Current and ongoing substance use disorder
• Medical complications capable of hindering the interpretation of the results (e.g. a a medical disease that induces weight loss)
• Presence of physical treatments (including drugs) hindering the interpretation of the results (e.g. chemotherapy for cancer)
• Being pregnant or intending to become pregnant during treatment

Where it is running

• Department of Eating and Weight Disorders, Villa Garda Hospital — Garda, Italy, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.