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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Diagnosis of anorexia nervosa - Age between 16 and 50 years - Written willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Diagnosis of anorexia nervosa * Age between 16 and 50 years * Written informed consent Exclusion Criteria: * 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

Treatments Being Tested

DIETARY_SUPPLEMENT

Amino-Ther Pro

Food supplements

DIETARY_SUPPLEMENT

Placebo

Maltodextrin

Locations (1)

Department of Eating and Weight Disorders, Villa Garda Hospital
Garda, Italy, Italy