RecruitingNot ApplicableNCT05290285

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

Efficacy and Tolerability of a Specific Blend of Amino Acids in Patients With Anorexia Nervosa Treated in a Hospital Setting. Double-blind Randomized Study Versus Placebo

Sponsor

Villa Garda Hospital

Enrollment

92 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

Anorexia Nervosa

Summary

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.

Eligibility

Min Age: 16 YearsMax Age: 50 Years

Inclusion Criteria3

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

Exclusion Criteria6

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